tretinoin and Acne-Vulgaris

Scarring is a common but difficult to manage consequence of acne vulgaris. The intricate balance between the degradation of collagen and its inhibition is disturbed during the formation of acne scars. We mostly rely on invasive, non-topical modalities for the treatment of acne scars which may not be indicated in all patients. There is also a need for maintainence therapies after these procedures.. The topical agents can be utilized as individual therapy, in combination with other modalities or delivered through assisted technology like iontophoresis. Retinoids have long been tried to prevent and treat acne scars. Tacrolimus and glycolic acid are among the newer sole agents that have been explored. Ablative lasers like Er:YAG, CO2 and Microneedling are being used in combination with topical agents like silicone gel, plasma gel, lyophilized growth factors, platelet rich plasma, insulin, and mesenchymal stem cells. These procedures not only increase the permeability of the topical agents but also concomitantly improve acne scars. Iontophoresis has proven beneficial in increasing the delivery of topical estriol and tretinoin.. There is lack of evidence to support the widespread use of these topical agents, and therefore, there is need for further well designed studies.

Topics: Acne Vulgaris; Administration, Topical; Cicatrix; Combined Modality Therapy; Humans; Treatment Outcome; Tretinoin

Topical tretinoin has historically been limited by poor tolerability and molecular instability. Research advances have enhanced its efficacy and tolerability, along with reducing oxidation and photodegradation. By overcoming historical limitations, tretinoin use can be extended to patient populations and clinical situations previously not suitable. This review discusses historical limitations of tretinoin, methods employed to overcome those limitations, use within clinical practice, and new formulations of tretinoin for the treatment of acne. J Drugs Dermatol. 2023;22(1):35-40. doi:10.36849/JDD.7146.

Topics: Acne Vulgaris; Administration, Cutaneous; Double-Blind Method; Humans; Keratolytic Agents; Severity of Illness Index; Treatment Outcome; Tretinoin

To assess the efficacy, safety, and clinical application of tretinoin 0.1%-benzoyl peroxide 3% cream for the topical treatment of acne vulgaris.. A systematic review of the literature was performed using the terms. All human studies published in English prior to November 2022 related to pharmacology, clinical trials, safety, and efficacy were evaluated for inclusion.. In two 12-week, phase 3, randomized, vehicle-controlled clinical trials, tretinoin 0.1%-benzoyl peroxide 3% cream significantly reduced inflammatory and noninflammatory facial acne lesions and significantly improved Investigator Global Assessment (IGA) rating to clear or almost clear. The cream has a suitable safety profile, with application site pain and dryness as the most common adverse events.. Tretinoin-BPO had similar IGA success compared to other topical retinoid and retinoid-BPO treatments for acne vulgaris. Compared to individual tretinoin and benzoyl peroxide therapy, the combination product streamlines application, which will improve medication adherence; however, the cost of tretinoin-BPO cream may be prohibitive.. Tretinoin 0.1%-benzoyl peroxide 3% cream is safe and effective for the treatment of moderate-to-severe acne. Long-term trial data on efficacy and tolerability are not yet available.

Topics: Acne Vulgaris; Benzoyl Peroxide; Dermatologic Agents; Gels; Humans; Immunoglobulin A; Retinoids; Treatment Outcome; Tretinoin

Microencapsulation has received extensive attention because of its various applications. Since its inception in the 1940s, this technology has been used across several areas, including the chemical, food, and pharmaceutical industries. Over-the-counter skin products often contain ingredients that readily and unevenly degrade upon contact with the skin. Enclosing these substances within a silica shell can enhance their stability and better regulate their delivery onto and into the skin. Silica microencapsulation uses silica as the matrix material into which ingredients can be embedded to form microcapsules. The FDA recognizes amorphous silica as a safe inorganic excipient and recently approved two new topical therapies for the treatment of rosacea and acne. The first approved formulation uses a novel silica-based controlled vehicle delivery technology to improve the stability of two active ingredients that are normally not able to be used in the same formulation due to potential instability and drug degradation. The formulation contains 3.0% benzoyl peroxide (BPO) and 0.1% tretinoin topical cream to treat acne vulgaris in adults and pediatric patients. The second formulation contains silica microencapsulated 5.0% BPO topical cream to treat inflammatory rosacea lesions in adults. Both formulations use the same amorphous silica sol-gel microencapsulation technology to improve formulation stability and skin compatibility parameters.

Topics: Acne Vulgaris; Adult; Benzoyl Peroxide; Child; Dermatologic Agents; Drug Combinations; Gels; Humans; Nonprescription Drugs; Pharmaceutical Vehicles; Rosacea; Treatment Outcome; Tretinoin

Acne and rosacea are common inflammatory skin conditions present in numerous racial and ethnic groups. There are distinct differences in clinical presentation, exacerbating factors, potential triggers and consequences of both conditions in individuals with skin of colour (SOC), classified as Fitzpatrick skin types III-VI. For example, acne can be complicated by the development of postinflammatory hyperpigmentation and keloid scarring in SOC, and this can influence treatment choice. Although rosacea is reported less frequently in SOC, this may be the result of delayed diagnosis or late presentation due to the difficulty in discerning the classic features of erythema in darker skin tones. In such cases, additional clues in the medical history and clinical examination may assist in making the diagnosis. This review aims to summarize nuances in both the diagnosis and management of these two common skin conditions in patients with SOC to support clinicians in providing an individualized treatment approach.

Topics: Acne Vulgaris; Adapalene; Diagnosis, Differential; Dicarboxylic Acids; Humans; Racial Groups; Rosacea; Skin Pigmentation; Tretinoin

Acne vulgaris is a common chronic inflammatory disease with a multifactorial pathogenesis. Although myriad acne treatments are available, current options may not be sufficient because of a lack of efficacy, limited tolerability, or burden of cost to patients. In this review, we highlight recently approved topical acne treatments, as well as those currently in clinical trials. Novel formulations of tretinoin, tazarotene, and minocycline provide modifications of and improvements to existing products. Trifarotene, a novel fourth-generation retinoid, has demonstrated improved tolerability compared with existing topical retinoids. Clascoterone is a novel first-in-class antiandrogen that topically addresses the hormonal etiology of acne. The late-phase clinical trials pipeline consists of agents with bactericidal and anti-sebum mechanisms. Although it is evident that acne treatments continue to evolve, it is important to recognize the need for further comparative studies among new and existing agents to define optimal treatment algorithms that address not only safety and efficacy but also cost-effective care.

Topics: Acne Vulgaris; Dermatologic Agents; Humans; Minocycline; Retinoids; Treatment Outcome; Tretinoin

Acne vulgaris has a multifactorial pathogenesis, and combination therapy is recommended in most patients. A tretinoin 0.1%/benzoyl peroxide 3% (Tret-BPO) cream which uses a core-shell encapsulation system to enhance the stability of both active ingredients recently received approval from the Food and Drug Administration (FDA).. To review the pharmacokinetics, efficacy, and safety of recently approved Tret-BPO.. A review of literature was conducted using the EMBASE, MEDLINE (Pubmed), and Clinicaltrials.gov databases in December 2021. Articles in English discussing the use of Tret-BPO in the treatment of acne vulgaris were included.. In a phase 2 trial, Tret-BPO achieved Investigators Global Assessment (IGA) success more often (39.7%) than vehicle (12.3%; P<0.001). In 2 phase 3 trials, Tret-BPO had a higher success rate (Trial 1: 38.5% and Trial 2: 25.4%) when compared with vehicle (Trial 1: 11.5% and Trial 2: 14.7%; P<0.001 and P=0.017).. This review was limited by the lack of clinical trials assessing the efficacy and safety of Tret-BPO compared with other acne treatments.. Tret-BPO is a safe and effective novel therapy for acne vulgaris. Poor adherence is a major hurdle in management; the combination of two separate first-line drugs may address this hurdle by decreasing the complexity of treatment regimens. J Drugs Dermatol. 2022;21(10):1098-1103. doi:10.36849/JDD.6808.

Topics: Acne Vulgaris; Adapalene; Benzoyl Peroxide; Dermatologic Agents; Double-Blind Method; Drug Combinations; Gels; Humans; Immunoglobulin A; Treatment Outcome; Tretinoin

Acne vulgaris is a chronic disfiguring inflammatory disease of adolescents and adults affecting up to 90% of the population around the world. The sequence of etiopathogenesis in acne is not completely understood but involves abnormalities in sebum production, follicular plugging, proliferation of propionibacterium acnes, and chronic inflammation.. This review aims to summarize the features of the topical selective RAR agonists in treating acne vulgaris with a special emphasis on the 4th generation topical retinoid trifarotene.. Studies were identified by searching electronic databases (MEDLINE and PubMed) till August 2019 and reference lists of respective articles. Only articles published in English language were included.. Topical retinoids have been first line of treatment for more than 30 years now in treating mild to moderate acne vulgaris. Third generation retinoids like adapalene and tazarotene are selective RAR and γ agonists, having an additional anti-inflammatory action along with their comedolytic effects and work well in combinations with topical antibiotics, due to the stability of chemical composition.. Trifarotene is a new 4th generation retinoid with selective action on RAR-γ receptor alone, which is specific for skin, and it is safe for long-term maintenance therapy with good efficacy and tolerability.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Dermatologic Agents; Humans; Nicotinic Acids; Randomized Controlled Trials as Topic; Receptors, Retinoic Acid; Retinoids; Treatment Outcome; Tretinoin

Acne is an inflammatory disorder with a high global burden. It is common in adolescents and primarily affects sebaceous gland-rich areas. The clinical benefit of the topical acne treatments azelaic acid, salicylic acid, nicotinamide, sulphur, zinc, and alpha-hydroxy acid is unclear.. To assess the effects of topical treatments (azelaic acid, salicylic acid, nicotinamide, zinc, alpha-hydroxy acid, and sulphur) for acne.. We searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers.. Clinical randomised controlled trials of the six topical treatments compared with other topical treatments, placebo, or no treatment in people with acne.. We used standard methodological procedures expected by Cochrane. Key outcomes included participants' global self-assessment of acne improvement (PGA), withdrawal for any reason, minor adverse events (assessed as total number of participants who experienced at least one minor adverse event), and quality of life.. We included 49 trials (3880 reported participants) set in clinics, hospitals, research centres, and university settings in Europe, Asia, and the USA. The vast majority of participants had mild to moderate acne, were aged between 12 to 30 years (range: 10 to 45 years), and were female. Treatment lasted over eight weeks in 59% of the studies. Study duration ranged from three months to three years. We assessed 26 studies as being at high risk of bias in at least one domain, but most domains were at low or unclear risk of bias. We grouped outcome assessment into short-term (less than or equal to 4 weeks), medium-term (from 5 to 8 weeks), and long-term treatment (more than 8 weeks). The following results were measured at the end of treatment, which was mainly long-term for the PGA outcome and mixed length (medium-term mainly) for minor adverse events. Azelaic acid In terms of treatment response (PGA), azelaic acid is probably less effective than benzoyl peroxide (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.72 to 0.95; 1 study, 351 participants), but there is probably little or no difference when comparing azelaic acid to tretinoin (RR 0.94, 95% CI 0.78 to 1.14; 1 study, 289 participants) (both moderate-quality evidence). There may be little or no difference in PGA when comparing azelaic acid to clindamycin (RR 1.13, 95% CI 0.92 to 1.38; 1 study, 229 participants; low-quality evidence), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence). Low-quality evidence indicates there may be no differences in rates of withdrawal for any reason when comparing azelaic acid with benzoyl peroxide (RR 0.88, 95% CI 0.60 to 1.29; 1 study, 351 participants), clindamycin (RR 1.30, 95% CI 0.48 to 3.56; 2 studies, 329 participants), or tretinoin (RR 0.66, 95% CI 0.29 to 1.47; 2 studies, 309 participants), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence). In terms of total minor adverse events, we are uncertain if there is a difference between azelaic acid compared to adapalene (1 study; 55 participants) or benzoyl peroxide (1 study, 30 participants) (both very low-quality evidence). There may be no difference when comparing azelaic acid to clindamycin (RR 1.50, 95% CI 0.67 to 3.35; 1 study, 100 participants; low-quality evidence). Total minor adverse events were not reported in the comparison of a. Compared to benzoyl peroxide, azelaic acid probably leads to a worse treatment response, measured using PGA. When compared to tretinoin, azelaic acid probably makes little or no difference to treatment response. For other comparisons and outcomes the quality of evidence was low or very low. Risk of bias and imprecision limit our confidence in the evidence. We encourage the comparison of more methodologically robust head-to-head trials against commonly used active drugs.

Topics: Acne Vulgaris; Adapalene; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Bias; Child; Clindamycin; Dermatologic Agents; Dicarboxylic Acids; Erythromycin; Female; Glycolates; Humans; Keratolytic Agents; Male; Mandelic Acids; Niacinamide; Patient Dropouts; Pyruvic Acid; Quality of Life; Salicylic Acid; Sulfur; Tretinoin; Young Adult; Zinc

Acne vulgaris (AV) is one of the most common diseases that we encounter in our clinics every day.

Topics: Acne Vulgaris; Administration, Topical; Clindamycin; Dermatologic Agents; Drug Combinations; Humans; Severity of Illness Index; Tretinoin

Topical treatment is the mainstay of acne therapy. The most commonly prescribed topical medications for acne include benzoyl peroxide, clindamycin, and retinoids. Despite their effectiveness in treating mild to moderate acne vulgaris, these topical medications are found to be irritating, and are historically associated with poor tolerability and diminished patient adherence. Thus, choosing the right formulation that will be effective and well tolerated is essential. Novel formulations that optimize drug concentration and utilize improved delivery vehicles have helped to enhance the tolerability and efficacy, and allow for less frequent application or co-application of drugs that were previously considered incompatible. This article will review the goals of topical therapy for the treatment of acne, in addition to common therapies and their challenges. Advanced formulations and combination formulations of benzoyl peroxide, clindamycin, and tretinoin will also be discussed. J Drugs Dermatol. 2018;17(6 Suppl):s6-10.

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Drug Combinations; Drug Compounding; Exanthema; Humans; Retinoids; Treatment Outcome; Tretinoin

Hunt et al. show that olumacostat glasaretil, an inhibitor of acetyl coenzyme A carboxylase, reduces saturated and monounsaturated fatty acyl chains in sebaceous lipids. Topical olumacostat glasaretil application decreases hamster ear sebaceous gland size and shows efficacy in treating patients with acne vulgaris. Olumacostat glasaretil-mediated sebum suppression may reduce Propionibacterium acnes growth and biofilm formation, comedogenesis, and inflammation.

Topics: Acne Vulgaris; Administration, Cutaneous; Humans; Keratolytic Agents; Sebum; Tretinoin

Acne and rosacea are common inflammatory processes historically classified in the same disease category, but evolving understanding of their disparate pathophysiology and exacerbating factors have generated an enormous armamentarium of therapeutic possibilities. Patients seek over-the-counter therapies first when managing cutaneous disease; therefore, this review defines ingredients considered to be effective over-the-counter acne and rosacea products, their mechanisms, and safe formulations, including botanical components, oral supplements, and other anecdotal options in this vast skin care domain.

Topics: Acne Vulgaris; Administration, Cutaneous; Astringents; Benzoyl Peroxide; Dermatologic Agents; Detergents; Evidence-Based Medicine; Global Health; Humans; Hydroxy Acids; Kinetin; Niacinamide; Nonprescription Drugs; Phototherapy; Randomized Controlled Trials as Topic; Resorcinols; Rosacea; Salicylates; Sulfur; Sunscreening Agents; Tea Tree Oil; Treatment Outcome; Tretinoin; Zinc

Retinoic acid is a physiological compound of human blood. Blood levels range from 1000 to 7000 pg/mL (usually 1500-5000 pg/mL). Results of studies on absorption of topical retinoic acid in laboratory animals, although rather conflicting, demonstrate that it induces plasma concentrations which are well below concentrations caused by non-teratogenic oral doses. In humans, minimal percutaneous absorption of tretinoin was observed after topical applications. Neither single dose nor long-term treatment with topical tretinoin affect the endogenous levels of retinoic acid or its metabolites. Topical application of tretinoin at doses used in acne unlikely induces systemic effects. Although some clinical cases of suspected tretinoin-related embryotoxicity have been described, three prospective cohort studies clearly demonstrated the safety of topical tretinoin as an embryotoxic agent.

Topics: Acne Vulgaris; Administration, Topical; Animals; Dermatologic Agents; Dose-Response Relationship, Drug; Female; Humans; Pregnancy; Retinoids; Skin Absorption; Teratogens; Tretinoin

The Global Alliance to Improve Outcomes in Acne Group recommends retinoid-based combination therapy as first-line therapy and the preferred treatment approach for almost all acne patients except those with the most severe disease. Clindamycin 1% (as clindamycin phosphate 1.2%)/tretinoin 0.025% (Clin-RA) is a new fixed-dose retinoid-based combination therapy. The aqueous-based gel formulation of Clin-RA was designed to minimize skin irritation and optimize adherence with the therapy. It contains both solubilized and crystalline tretinoin which allows the retinoid to be slowly released onto the skin surface and decreases the potential for cutaneous irritation. A pooled analysis of three pivotal studies involving 4550 acne patients showed that Clin-RA is well tolerated and effective at treating both inflammatory and non-inflammatory acne lesions. The onset of action of Clin-RA is rapid occurring within 2 weeks of treatment initiation. It is not associated with acne flaring or an increase in clindamycin-resistant Propionibacterium acnes counts. Clin-RA is considered as effective as adapalene 0.1%/benzoyl peroxide (BPO) 2.5%, whereas Clin-RA has a more favourable tolerability profile. Clin-RA may be more effective than clindamycin 1%/BPO 5% at treating non-inflammatory acne lesions since the latter does not contain a retinoid to target comedones. Clin-RA is also easy for patients to handle and apply, and has the advantage of not containing BPO which can bleach hair and fabrics. Taken together, the profile of Clin-RA suggests Clin-RA to be a first-line treatment for patients with facial acne.

Topics: Acne Vulgaris; Anti-Bacterial Agents; Clindamycin; Drug Combinations; Drug Resistance, Bacterial; Female; Gels; Humans; Keratolytic Agents; Treatment Outcome; Tretinoin

Topical tretinoin has been a standard treatment for acne vulgaris for more than 4 decades. While tretinoin has demonstrated proven efficacy in the treatment of acne lesions, it also is associated with the potential for skin irritation. Newer formulations have been designed to optimize both the drug concentration and the delivery vehicle with the aim to enable clinicians to provide increasingly effective acne treatment that minimizes irritation. These therapies include formulations with varying concentrations of tretinoin and vehicles that utilize a microsponge delivery system, hydrogels and micronized tretinoin, or propolymers. The purpose of this review is to evaluate different formulations and combinations of tretinoin in the treatment of acne vulgaris. While these advanced formulations were designed for controlled release of active ingredient, and have the potential to reduce cutaneous irritation relative to standard tretinoin cream and gel formulations, there is a need for comparative studies to evaluate the relative benefits of each of these advanced tretinoin formulations in optimizing acne treatment.

Topics: Acne Vulgaris; Chemistry, Pharmaceutical; Drug Eruptions; Erythema; Humans; Hydrogels; Keratolytic Agents; Microspheres; Pharmaceutical Vehicles; Polypropylenes; Polyurethanes; Tretinoin

Topical tretinoin has been approved for use in dermatology for 40 years and is currently approved for the treatment of acne vulgaris and photodamage. During this time, topical tretinoin has accumulated significant efficacy and safety data in the treatment of acne and photodamaged skin and demonstrated clinical potential for treating a range of other dermatologic conditions. The diverse effects may be due to complex underlying mechanisms of action associated with tretinoin, including keratolytic activity, collagenesis, and other mechanisms associated with the activation of nuclear retinoic acid receptors (RARα, RARβ, and RARγ). In this article, we review the history of topical tretinoin use to date and outline emerging research suggesting that topical tretinoin may have potential clinical use for treating a multitude of other dermatological conditions when used either as monotherapy or in combination with other agents. We also describe newer formulations of topical tretinoin that have been designed to reduce irritation potential. In light of the substantial history of safety and efficacy of topical tretinoin in acne and photodamage, we speculate that it holds promise in treating many additional dermatological conditions, which may be explored in future research.

Topics: Acne Vulgaris; Administration, Cutaneous; Humans; Keratolytic Agents; Skin Aging; Skin Diseases; Tretinoin; Ultraviolet Rays

Vitamin A is required for the proper functioning of many important metabolic and physiologic activities, including vision, gene transcription, the immune system and skin cell differentiation. Both excessive and deficient levels of vitamin A lead to poor functioning of many human systems. The biologically active form, retinoic acid, binds to nuclear receptors that facilitate transcription that ultimately leads to it's physiological effects. Retinoids are derivatives of vitamin A that are medications used to treat acne vulgaris, psoriasis, ichthyosis (and other disorders of keratinization), skin cancer prevention as well as several bone marrow derived neoplasias. Systemic retinoids are teratogenic and have to be prescribed with caution and close oversight. Other potential adverse events are controversial. These include the relationship of retinoid derivatives in sunscreens, their effects on bone mineral density, depression and suicidal ideation and inflammatory bowel disease. These controversies will be discussed in detail.

Topics: Acne Vulgaris; Bone and Bones; Cell Differentiation; Depression; Female; Humans; Ichthyosis; Inflammatory Bowel Diseases; Male; Nutrition Policy; Psoriasis; Retinoids; Sex Factors; Skin; Suicidal Ideation; Sunscreening Agents; Tretinoin; Vitamin A; Vitamins

Crowdsourcing is a novel process of data collection that can provide insight into the effectiveness of acne treatments in real-world settings. Little is known regarding the feasibility of crowdsourcing as a means of collecting dermatology research data, the quality of collected data, and how the data compare to the published literature.. The objective of this analysis is to compare acne data collected from a medical crowdsourcing site with high-quality controlled studies from peer-reviewed medical literature.. Crowdsourced data was collected from 662 online acne patients. Online patients reported data in a Likert-type format to characterize their symptom severity (740 total responses) and their treatment outcomes (958 total responses). The crowdsourced data were compared with meta-analyses and reviews on acne treatment from August 20, 2010 to August 20, 2011.. We compared topical, oral systemic, alternative, phototherapy, and physical acne treatments of crowdsourced data to published literature. We focused on topical tretinoin due to the large number of online patient responses. While approximately 80% of tretinoin users observed clinical improvement after a 12-week treatment period in clinical trials, 46% of online users reported improvement in an unspecified time period. For most topical treatments, medication with high efficacy in clinical trials did not produce high effectiveness ratings based on the crowdsourced online data.. While limitations exist with the current methods of crowdsourced data collection, with standardization of data collection and use of validated instruments, crowdsourcing will provide an important and valuable platform for collecting high-volume patient data in real-world settings.

Topics: Acne Vulgaris; Administration, Cutaneous; Controlled Clinical Trials as Topic; Crowdsourcing; Dermatologic Agents; Humans; Phototherapy; Time Factors; Treatment Outcome; Tretinoin

Acne vulgaris affects over 80% of teenagers, and persists beyond the age of 25 years in 3% of men and 12% of women. Typical lesions of acne include comedones, inflammatory papules, and pustules. Nodules and cysts occur in more severe acne and can cause scarring and psychological distress.. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical and oral treatments in people with acne vulgaris? We searched: Medline, Embase, The Cochrane Library, and other important databases up to February 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).. We found 69 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.. In this systematic review we present information relating to the effectiveness and safety of the following interventions: topical treatments (adapalene, azelaic acid, benzoyl peroxide, clindamycin, erythromycin [alone or plus zinc]; isotretinoin, tetracycline, tretinoin); and oral treatments (doxycycline, isotretinoin, lymecycline, minocycline, oxytetracycline, tetracycline).

Topics: Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide; Humans; Isotretinoin; Lymecycline; Minocycline; Tretinoin

The science of cutaneous drug delivery is focused on overcoming the major force of resistance to drug penetration and permeation-the stratum corneum. Acne vulgaris is a multifactorial disease of the pilosebaceous unit, resulting from abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation and inflammation. Topical treatment of even mild-moderate acne requires combination topical therapy, yet often systemic therapy is needed to ultimately confer an acceptable clinical endpoint. New delivery systems have emerged in response to the limited routes of entry and therefore efficacy of topical regimens. The unique physical and optical properties of micro/nano encapsulation of known therapeutics such as benzoyl peroxide and tretinoin allow for both improved efficacy while minimizing issues of compliance and adverse events. Vehicles that offer both inherent biological reactivity and permeation enhancement have also been shown improvement over the current armament of topical drug delivery. This current and exciting path of topical drug development will likely be continued with investigative vigor.

Topics: Acne Vulgaris; Administration, Cutaneous; Benzoyl Peroxide; Dermatologic Agents; Drug Delivery Systems; Humans; Pharmaceutical Vehicles; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Animals; Clindamycin; Clinical Trials as Topic; Drug Combinations; Humans; Photosensitivity Disorders; Retinoids; Tretinoin

Increased fibroblast growth factor receptor-2 (FGFR2) signaling has been proposed to be involved in acne pathogenesis and explains acne lesions in Apert syndrome and unilateral acneiform nevus associated with gain-of-function point mutations of FGFR2. If, indeed, increased FGFR2 signaling plays a major pathogenic role in follicular hyperkeratinization and sebaceous gland hypertrophy in acne, effective anti-acne drugs may attenuate increased FGFR2 signaling. The purpose of this article is to elucidate the hypothesis that known anti-acne agents may operate by downregulation of increased FGFR2 signaling. Anti-androgens suppress FGF-ligand expression, benzoyl peroxide induces FGFR2 downregulation by lysosomal receptor degradation, azelaic acid inhibits mitochondrial ATP formation required for receptor tyrosine kinase phosphorylation, tetracyclines inhibit the expression, and activity of FGFR2b downstream matrix metalloproteinases, and retinoids attenuate the FGFR2 pathway at several regulatory levels of the signal transduction cascade critical for cell cycle control, cell proliferation, differentiation, and lipogenesis. Erythromycin, a P-450 inhibitor, may interfere with FGFR2 signaling by its inhibitory effect on retinoid catabolism. The gain-of-function mutations of FGFR2 in Apert syndrome and unilateral acneiform nevus, and the proposed synergistic inhibitory interactions of anti-acne agents at various levels of the FGFR2-signaling cascade underline the role of FGFR2 signaling in the pathogenesis of acne.

Topics: Acne Vulgaris; alpha-MSH; Androgen Antagonists; Benzoyl Peroxide; Dicarboxylic Acids; Erythromycin; Humans; Interleukin-1alpha; Isotretinoin; Reactive Oxygen Species; Receptor, ErbB-2; Signal Transduction; Tetracyclines; Tretinoin

The efficacy of the antiacne topical drugs is well established. The local side effects, however, mainly cutaneous irritation, erythema, dryness, peeling and scaling, remain major problems. Novel vesicular and particulate drug delivery systems have been proposed to reduce the side effects of drugs commonly used in the topical treatment of acne.. This review focuses on the development and evaluation of antiacne drug-loaded vesicular and particulate delivery systems (liposomes, polymeric microspheres and solid lipid nanoparticles) for topical treatment, their advantages and challenges.. All the literature available was reviewed to highlight the potential of these novel systems for the topical treatment of acne.. The encapsulation of antiacne drugs in vesicular and particulate delivery systems represents an innovative alternative to minimize side effects, while preserving their efficacy. This can be obtained by the capacity of these systems to provide controlled release or to improve the drug penetration into skin or even into the pilosebaceous unit.

Topics: Acne Vulgaris; Administration, Topical; Benzoyl Peroxide; Clindamycin; Clinical Trials as Topic; Drug Delivery Systems; Drug Stability; Humans; Imidazoles; Liposomes; Microspheres; Nanoparticles; Nitriles; Tretinoin

An aqueous gel formulation containing solubilized clindamycin phosphate 1.2% and a stable combination of both solubilized and crystalline tretinoin 0.025% (clin/tret) has been evaluated in 3 pivotal phase 3 studies, among other studies including a 52-week trial. The pivotal studies enrolled 4550 participants 12 years and older with mild, moderate, and severe acne vulgaris. The combination clin/tret gel was effective in reducing both inflammatory and noninflammatory lesions and was well-tolerated. This article reviews important vehicle characteristics of the combination gel as well as formulation stability and tolerability data that are potentially clinically relevant.

Topics: Acne Vulgaris; Administration, Cutaneous; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatitis, Irritant; Dermatologic Agents; Drug Combinations; Drug Interactions; Drug Stability; Gels; Humans; Pharmaceutical Vehicles; Skin Absorption; Tretinoin

Acne vulgaris can persist beyond adolescence into the fourth decade of life or later; most patients have a combination of inflammatory and noninflammatory lesions.. To determine whether tretinoin microsphere gel (TMG) 0.04% applied once nightly is well tolerated and effective in reducing inflammatory and noninflammatory lesions in adolescents and adults with mild to moderate facial acne.. The results of 3 randomized, double-blind, vehicle-controlled studies of TMG 0.04% applied once nightly for 12 consecutive weeks in a total of 629 patients, ages 11 to 49 years, were combined. Reductions in acne lesion counts were assessed twice monthly, and an investigator's global evaluation (IGE) was performed at the study endpoint (week 12).. Tretinoin microsphere gel 0.04% was significantly superior to the vehicle gel in reducing both inflammatory and noninflammatory lesions over the 12-week treatment period, and produced a higher successful treatment rate than the vehicle gel, as judged by IGE ratings at week 12. The most frequent adverse events were erythema, peeling, and dryness, which were mostly mild and occurred in 59.7% to 63.3% of patients with TMG 0.04%, as compared with 26.9% to 51.0% of patients with the vehicle gel (placebo).. The TMG 0.04% formulation is significantly superior when compared to its vehicle gel in reducing inflammatory and noninflammatory acne lesions over a period of 12 weeks and is well tolerated.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Middle Aged; Randomized Controlled Trials as Topic; Tretinoin

Talarozole, being developed by Barrier Therapeutics Inc under license from Johnson & Johnson, is a potent and selective inhibitor of cytochrome P450 26-mediated breakdown of endogenous all-trans retinoic acid for the treatment of psoriasis and acne. Phase II clinical trials of an oral formulation of talarozole in patients with psoriasis and with acne, and a phase I clinical trial of a topical formulation have been completed. At the time of publication, Barrier Therapeutics had suspended the development of talarozole as part of a series of cost-cutting initiatives; the company had also been acquired by Stiefel Laboratories Inc. No formal announcement had been made regarding the further development of talarozole.

Topics: Acne Vulgaris; Animals; Benzothiazoles; Clinical Trials as Topic; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Humans; Psoriasis; Structure-Activity Relationship; Tretinoin; Triazoles

Topical retinoids represent a mainstay of acne treatment because they expel mature comedones, reduce microcomedone formation, and exert anti-inflammatory effects. The first-generation retinoid tretinoin (all-trans retinoic acid) and the synthetic third-generation polyaromatics adapalene and tazarotene are approved for acne treatment by the US FDA, whereas topical tretinoin, isotretinoin (13-cis retinoic acid), and adapalene are accredited in Canada and Europe. Topical retinoids have a favorable safety profile distinct from the toxicity of their systemic counterparts. Local adverse effects, including erythema, dryness, itching, and stinging, occur frequently during the early treatment phase. Their impact varies with the vehicle formation, skin type, frequency and mode of application, use of moisturizers, and environmental factors such as sun exposure or temperature. The broad anti-acne activity and safety profile of topical retinoids justifies their use as first-line treatment in most types of non-inflammatory and inflammatory acne. They are also suitable as long-term medications, with no risk of inducing bacterial resistance, for maintenance of remission after cessation of initial combination therapy.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Drug Therapy, Combination; Humans; Isotretinoin; Naphthalenes; Nicotinic Acids; Retinoids; Safety; Tretinoin

Clindamycin phosphate 1.2% and tretinoin 0.025% gel (CLIN/RA gel [ZIANA Gel]) is a novel topical combination agent approved by the FDA for the treatment of acne vulgaris in patients 12 years of age or older. A solution of clindamycin phosphate 1.2% combined with partially solubilized and crystalline tretinoin 0.025% suspended in an aqueous-based, alcohol-free gel formulation, CLIN/RA gel was studied in 2 randomized, vehicle-controlled trials involving more than 4,500 patients. Efficacy results from these studies showed that treatment with the combination significantly reduced lesion counts and improved patients' overall appearance to a greater extent than the individual components. Individual ingredients and the combination were well-tolerated. Among those treated with the combination formulation, discontinuation rates due to adverse events were 1% or less.

Topics: Acne Vulgaris; Clindamycin; Clinical Trials, Phase III as Topic; Drug Combinations; Humans; Randomized Controlled Trials as Topic; Treatment Outcome; Tretinoin

A major issue in treating acne in individuals of color is the need to treat and prevent postinflammatory hyperpigmentation (PIH), which is common in this population. This subset analysis reports the pigmentary changes in subjects of color with acne who were enrolled in a community-based trial comparing 3 different topical therapeutic regimens. All subjects received combination clindamycin 1%-benzoyl peroxide (BPO) 5% topical gel containing glycerin and dimethicone. Subjects were randomized to receive this combination therapy in addition to either a tretinoin microsphere (RAM) gel at concentrations of either 0.04% or 0.1% or adapalene (AP) gel 0.1%. There was a trend toward better resolution of hyperpigmentation in the subjects receiving the clindamycin-BPO topical gel in combination with RAM gel 0.04%.

Topics: Acne Vulgaris; Adapalene; Anti-Bacterial Agents; Asian People; Benzoyl Peroxide; Black or African American; Clindamycin; Dermatologic Agents; Dimethylpolysiloxanes; Drug Combinations; Drug Therapy, Combination; Glycerol; Hispanic or Latino; Humans; Hyperpigmentation; Keratolytic Agents; Naphthalenes; Randomized Controlled Trials as Topic; Skin Pigmentation; Tretinoin

Newer topical therapies approved by the US Food and Drug Administration (FDA) for the treatment of acne vulgaris are dapsone gel 5% and clindamycin phosphate 1.2% and tretinoin 0.025% combination gel. Both are formulated in aqueous-based gel vehicles. These newer topical acne products have been shown to be effective and safe in pivotal 12-week phase 3 trials and long-term studies completed over 12 months. This article reviews applicable pharmacokinetic, efficacy, and safety data reported with both products.

Topics: Acne Vulgaris; Administration, Topical; Anti-Infective Agents; Clindamycin; Dapsone; Drug Combinations; Humans; Keratolytic Agents; Treatment Outcome; Tretinoin

Topics: Acne Vulgaris; Adapalene; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Dicarboxylic Acids; Doxycycline; Erythromycin; Humans; Isotretinoin; Minocycline; Naphthalenes; Tetracycline; Tretinoin; Zinc

Connetics Corporation (USA) has licensed a first-in-class, dual-action 1% clindamycin/0.025% tretinoin aqueous gel [Clindamycin phosphate/tretinoin gel, Velac, Velac Gel] from Yamanouchi Europe BV. The product combines the anti-inflammatory and antibacterial properties of clindamycin with the beneficial effects of tretinoin [all-trans-retinoic acid], and is in phase III trials for the treatment of acne. On 1 April 2005, Yamanouchi merged with Fujisawa to form Astellas Pharma. Connetics has exclusive development and commercialisation rights for clindamycin/tretinoin gel in the US and Canada, and has non-exclusive rights to the product in Mexico. Under the licensing agreement terms, Connetics initially paid Yamanouchi a dollar US 2 million licensing fee, as well as milestone payments and royalties on future products. In the fourth quarter of 2002, a dollar US 2 million milestone payment was made to Yamanouchi following the initiation of pivotal phase III trials in the US and Canada, and in the third quarter of 2004 a dollar US 3 million milestone payment was made to Yamanouchi following the filing of an NDA to the US FDA. In March 2004, Connectics reported that clindamycin/tretinoin is approved in Europe. It appears that this approval was specifically for France. In October 2004, Connetics announced that the US FDA has accepted its NDA filing for clindamycin/tretinoin. Two pivotal phase III trials of clindamycin/tretinoin have been conducted in the US and Canada. These trials included 2219 patients with acne who received 12 weeks' treatment in the double-blind, placebo- and active-controlled trials. Results of these trials were reported in March 2004. Connetics anticipates launch of the product during mid-2005. An action date of 25 June 2005 has been given by the FDA for it to respond to the NDA submission. Phase III trials in patients with acne in Europe have shown clindamycin/tretinoin gel to be as effective and safe as other leading topical therapies. Data from a combined analysis of six controlled efficacy and safety trials of clindamycin/tretinoin have been reported. The patent for clindamycin/tretinoin gel is held by Yamanouchi in the US and internationally. Other analysts, at CIBC World Markets, were quoted saying that Evoclin represents Connetics' 'first foray' into the acne market (followed by others, such as Velac), a market that has been valued at dollar US 1.7 billion, of which that for topical antibiotics is worth approximately dollar US 500 mi

Topics: Acne Vulgaris; Anti-Bacterial Agents; Anti-Inflammatory Agents; Clindamycin; Clinical Trials, Phase III as Topic; Drug Combinations; Drugs, Investigational; Gels; Humans; Keratolytic Agents; Tretinoin

Topics: Acne Vulgaris; Adapalene; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Dicarboxylic Acids; Drug Therapy, Combination; Erythromycin; Humans; Isotretinoin; Naphthalenes; Tetracycline; Tretinoin; Zinc

The choice of vehicle is an important consideration in acne therapy. Because the epidermal barrier may be impaired by both the underlying disorder and the use of some topical treatments for acne, vehicle formulations that minimize barrier impairment, help to restore barrier function, and limit signs and symptoms of skin irritation are valuable components of acne therapy, especially early in the course of treatment or with combination regimens. Formulations with ingredients that provide moisturization, such as humectants and emollients, are ideal in the management of acne. Tretinoin microsphere and tretinoin polyolprepolymer-2 are vehicle modifications designed to release tretinoin in a slow controlled manner, thus minimizing the potential for irritation associated with standard tretinoin formulations. A combination of clindamycin and benzoyl peroxide in a water-based gel formulated with the humectant glycerin and the emollient dimethicone has been shown to improve skin tolerability and overall patient preference compared with the same active ingredients formulated without the special additives that provide moisturization.

Topics: Acne Vulgaris; Clindamycin; Drug Delivery Systems; Drug Therapy, Combination; Emollients; Gels; Humans; Keratolytic Agents; Microspheres; Tretinoin

Routine everyday care of skin is an essential part of optimal patient management. Common problems such as xerosis, dermatitis, eczema, psoriasis, acne, rosacea, and photodamage leave the skin vulnerable to external insults, partly as a result of varying levels of barrier dysfunction. Cosmetic surgery procedures also typically damage the stratum corneum (SC) and leave skin with a very weak barrier during recovery phase. Cleansing is an important aspect of any skin care, since it not only removes unwanted dirt, soil, and bacteria from skin, but also removes dead surface cells, preparing skin to better absorb topically applied drugs/medication. Care must be taken to minimize any further weakening of the SC barrier during cleansing. Cleansers based on mild synthetic surfactants and/or emollients that cause minimal barrier perturbation are ideal for these patients. The present paper is a brief review of four clinical trials that evaluated the efficacy and compatibility of either mild syndet bars or cleansers in patients with atopic dermatitis, acne, rosacea, or patients who had received chemical peels or Retin-A(R) (tretinoin) treatment for sustained photodamage.

Topics: Acne Vulgaris; Clinical Trials as Topic; Dermatitis, Atopic; Detergents; Humans; Hydroxy Acids; Rosacea; Severity of Illness Index; Skin Care; Skin Diseases; Surface-Active Agents; Tretinoin

Topics: Acne Vulgaris; Anti-Bacterial Agents; Evidence-Based Medicine; Humans; Keratolytic Agents; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Adapalene; Dermatologic Agents; Humans; Keratolytic Agents; Meta-Analysis as Topic; Multicenter Studies as Topic; Naphthalenes; Nicotinic Acids; Randomized Controlled Trials as Topic; Retinoids; Treatment Outcome; Tretinoin; United States

Topical tazarotene has shown superior efficacy over other topical retinoids, including adapalene and tretinoin, in the treatment of mild to moderate acne. A meta-analysis of data from 6 multicenter, double-blind, randomized comparative trials was performed to determine how patient characteristics influence the efficacy and tolerability of topical tazarotene. Data on 468 patients who used tazarotene 0.1% gel or cream once daily for 12 weeks were collected. Topical tazarotene was effective and well tolerated, regardless of patients' acne severity, skin type, sex, or ethnicity. In general, 'using the cream formulation rather than the gel formulation optimized tolerability. These results indicate that topical tazarotene 0.1% gel and cream are efficacious and well-tolerated treatment options for clearing acne vulgaris across a broad range of patients.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Adult; Dermatologic Agents; Drug Administration Schedule; Female; Gels; Humans; Male; Multicenter Studies as Topic; Naphthalenes; Nicotinic Acids; Randomized Controlled Trials as Topic; Retinoids; Severity of Illness Index; Time Factors; Treatment Outcome; Tretinoin; United States

Adapalene (Differin) is a retinoid agent indicated for the topical treatment of acne vulgaris. In clinical trials, 0.1% adapalene gel has proved to be effective in this indication and was as effective as 0.025% tretinoin gel, 0.1% tretinoin microsphere gel, 0.05% tretinoin cream and 0.1% tazarotene gel once every two days; however, the drug was less effective than once-daily 0.1% tazarotene gel. It can be used alone in mild acne or in combination with antimicrobials in inflammatory acne and has proved efficacious as maintenance treatment. Adapalene has a rapid onset of action and a particularly favorable tolerability profile compared with other retinoids. These attributes can potentially promote patient compliance, an important factor in treatment success. Adapalene is, therefore, assured of a role in the first-line treatment of acne vulgaris.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Anti-Inflammatory Agents, Non-Steroidal; Dermatologic Agents; Drug Administration Schedule; Gels; Humans; Multicenter Studies as Topic; Naphthalenes; Nicotinic Acids; Randomized Controlled Trials as Topic; Treatment Outcome; Tretinoin

Retinoids target several pathoetiologic events of acne vulgaris. The undisputed efficacy of tretinoin, and yet its underutilization, due to apprehension of retinoid dermatitis, triggered a search for newer, well-tolerated retinoids. The discovery of nuclear retinoic acid receptors has provided clues to a rational design of synthetic, receptor-selective retinoic acid agonists. Adapalene is an addition to the arsenal of topical retinoids. It possesses the biological properties of tretinoin, but has a distinct physiochemical profile, including high lipophilicity and increased chemical and photostability. It exhibits selective affinity for nuclear retinoic acid receptors and does not bind to cytosolic retinoic acid binding proteins. It exemplifies the formulation of a novel retinoid with specific pharmacologic profile and clinical objectives. Accordingly, numerous clinical trials have compared adapalene and tretinoin in the management of acne vulgaris and concluded that tretinoin 0.05% gel exhibits a greater anti-acne efficacy than adapalene 0.1% gel, but has higher skin irritation potential. This article reviews the pharmacology of adapalene, including its retinoid receptor binding profile, antiproliferative effects, cell differentiation modulation, comedolytic and anti-inflammatory activity, and specifically focuses on the comparison of the efficacy and irritation profile of adapalene and tretinoin.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Humans; Keratolytic Agents; Naphthalenes; Tretinoin

Precise classification methods are used to define acne according to type (comedonal, papulopustular, or nodular) and severity. The relative effectiveness of several topical and systemic agents has been established in clinical trials, making possible an algorithm of specific treatment decisions based on acne classification.

Topics: Acne Vulgaris; Adapalene; Administration, Oral; Administration, Topical; Algorithms; Anti-Bacterial Agents; Benzoyl Peroxide; Contraceptives, Oral; Controlled Clinical Trials as Topic; Cost-Benefit Analysis; Decision Trees; Dermatologic Agents; Dicarboxylic Acids; Humans; Isotretinoin; Macrolides; Naphthalenes; Nicotinic Acids; Salicylates; Tretinoin; United States

Acne is a disease that can be seen in the first year of age, early childhood, prepubertal age and puberty. Neonatal acne is due mainly to considerable sebum excretion rate, and infantile acne because of high androgens of adrenal origin in girls and of adrenal and testes in boys. These pathogenic mechanisms are characteristic in these ages. Important factors like early onset of comedones and high serum levels of dehydroepiandrosterone sulfate are predictors of severe or long-standing acne in prepubertal age. Hereditary factors play an important role in acne. Neonatal, nodulocystic acne and conglobate acne has proven genetic influences. Postadolescent acne is related with a first-degree relative with the condition in 50% of the cases. Chromosomal abnormalities, HLA phenotypes, polymorphism of human cytochrome P-450 1A1 and MUC1 gene are involved in the pathogenesis of acne. Several other genes are being studied.

Topics: Acne Vulgaris; Child; Child, Preschool; Cytochrome P-450 CYP1A1; Genotype; Humans; Infant; Infant, Newborn; Keratolytic Agents; Polymorphism, Genetic; Sebaceous Glands; Tretinoin

During the last 20 years, the number of topical and systemic drugs for the treatment of acne vulgaris has been enriched. Topical drugs on the one hand have been newly discovered or further developments of already available agents such as in the group of retinoids or galenic formulation have improved efficacy or local tolerance. Topical retinoids are a mainstay in acne treatment since 1962. All-trans retinoic acid was the first and is still in use. Its irritative potential has led to the new galenics, i.e. incorporation in microsponges and in propolyomers, which increased the tolerability significantly. The isomer of tretinoin, isotretinoin, has the same clinical efficacy, but also a lower irritancy. A real breakthrough was adapalene, a retinoid-like agent, with a different retinoid receptor-binding profile, but in addition to the same clinical efficacy on inflammatory and non-inflammatory acne lesions compared to tretinoin, a better tolerability and, therefore, compliance. Unfortunately, over the past years topical retinoids have been less used in inflammatory acne than they should be, taking the the mechanisms of action into account. Topical antimicrobials, in particular topical antibiotics, should be used less often than in the past and only for short periods to avoid the development of resistances. It seems better to combine those agents with topical retinoids, with BPO or with azelaic acid to enhance the efficacy and slow down the development of resistance. BPO is still the gold standard for papular-pustular acne of mild-to-moderate type in concentrations of 2-5%. Azelaic acid is an alternative with efficacy on the comedo and is antibacterial without development of resistances. Finally, the physical removal by electrocautery or CO(2) laser of multiple densely packed closed comedones, macrocomedones and microcysts is necessary to enhance the efficacy of topical comedolytic agents and to speed up the therapeutic results. Photodynamic therapy has not yet been proven efficacious in controlled studies. Blue and red light can probably be used in association with local agents but enhancement of the irritative potential of topical and systemic agents has to be considered.

Topics: Acne Vulgaris; Administration, Topical; Humans; Keratolytic Agents; Photochemotherapy; Retinoids; Tretinoin

Retinoids have been in sharp focus ever since their introduction 30 years ago. They include any drug (s) that bind to retinoid receptors and elicit a biological response. Enormous information on the subject seems to embroil the recent literature. Practically it is impossible to clearly comprehend the undercurrents. The meticulously dispensing text envisages surmounting the perspective reader's predicaments. Accordingly, retinoids and their related facets namely retinoid receptors, classification, mode of action, and the pharmacological diversity have been precisely defined. Commonly used systemic retinoids too have been given a substantial fresh look along with their monitoring. Overall, adverse effects and relative and absolute contraindications have been scrupulously incorporated. Human immuno deficiency virus (HIV) and isoretinoid for acne, in particular, have been highlighted. Micronized isotretinoin formulations have also been taken care so also commonly used topical retinoids. Tretinoin and their newer formulation have also been accounted for along with tretinoin polymer cream. Adapalene, a new chemical entity possessing a unique physico-chemical activity similar to that of tretinoin has also been dealt with. Newer retinoids are likely to be a subject of intrigue. A focus on future potentials of retinoids is its special ingredient. The inclusion of details of rexinoid the most recent introduction in their purview is likely to invoke interest to further consolidate its reckoning in future. All in all the text of the paper should provide an insight into the current rumbling around retinoids.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Administration, Oral; Chemistry, Pharmaceutical; Humans; Isotretinoin; Naphthalenes; Psoriasis; Receptors, Retinoic Acid; Retinoids; Skin Diseases; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Clindamycin; Drug Resistance, Bacterial; Drug Therapy, Combination; Erythromycin; Humans; Keratolytic Agents; Propionibacterium acnes; Time Factors; Tretinoin

Topical retinoic acid was introduced for acne treatment three decades ago. Since that time, researchers have discovered thousands of retinoids, originally defined as chemical analogs of vitamin A. After the identification of nuclear retinoid receptors in 1987, the definition of this class expanded to include molecules that bind to and activate such receptors. The receptor-selective retinoid agents, adapalene and tazarotene, were developed in the 1990s. Other innovations of the past decade include retinoid formulations and methods aimed at limiting retinoid absorption. Cutaneous irritation may be reduced without losing retinoid efficacy by inhibiting retinoid penetration into the deep epidermis and dermis. Examples include tretinoin in slow-release vehicles and the short-contact method of tazarotene gel therapy. Only trace amounts of adapalene are absorbed after topical application, perhaps explaining its relatively low irritancy. New formulations of existing agents, such as additional concentrations of tretinoin in microsphere gel and cream formulations of tazarotene, are now under investigation for acne. Current research focused on receptor selectivity holds the promise of yielding new retinoid molecules with improved benefits and safety.

Topics: Acne Vulgaris; Adapalene; Dermatologic Agents; Drug Combinations; Humans; Keratolytic Agents; Naphthalenes; Nicotinic Acids; Receptors, Retinoic Acid; Tretinoin; Vitamin A

Acne vulgaris is one of the most common inflammatory dermatoses and is seen in both the hospital setting and in general practice. Multiple factors are involved in the pathophysiology of acne, including: an alteration in the pattern of keratinization within the pilosebaceous follicles resulting in comedone formation; an increase in sebum production which is influenced by androgens; the proliferation of Propionibacterium acnes; and the production of perifollicular inflammation. Genetic and hormonal factors may also contribute to acne. Better understanding of the pathophysiology of the disease has led to the development of novel therapies which are directed at one or more of the implicated etiologic factors. Systemic antibiotics for acne have been the mainstay of treatment for many years. The main cause for concern following the use of systemic antibiotics is the emergence of antibiotic-resistant strains of P. acnes. Concomitant use of non-antibiotic therapies such as benzoyl peroxide helps to decrease the occurrence of resistance and can be effective in the treatment of resistant and nonresistant propionibacterial strains. However, no one agent is able to eradicate resistant strains completely and as resistant strains correlate to poor clinical response to therapy, prescribing strategies are required to minimize the occurrence of resistance to P. acnes. When assessing acne it is important to take an all embracing approach and to examine carefully for both the clinical and psychologic effects of the disease process. There are numerous forms of acne scarring and it is important to be aware of these as patients who are developing scarring merit early effective therapy. Some patients with acne will develop psychologic problems as a consequence of their condition. Even mild to moderate disease can be associated with significant depression and suicidal ideation and psychologic change does not necessarily correlate with disease severity. Acne scars themselves have been shown to produce significant psychopathology. When initiating treatment it is important to consider the aims of therapy. Treatment should be aimed at achieving clearance of acne, prevention of scarring and, where necessary, relief from any psychologic stress resulting from the acne. Therapy should be commenced early in the disease process in order to prevent scarring and it is important to select appropriate therapies according to the clinical signs and psychologic disability. It is also important t

Topics: Acne Vulgaris; Administration, Cutaneous; Administration, Oral; Androgen Antagonists; Anti-Bacterial Agents; Body Image; Cicatrix; Drug Therapy, Combination; Humans; Keratolytic Agents; Patient Satisfaction; Patient Selection; Risk Factors; Self Concept; Skin Care; Stress, Psychological; Treatment Outcome; Tretinoin

Adapalene, a naphthoic-acid derivative, possesses some of the biological activities of tretinoin but has distinct physicochemical properties and binding properties for selective affinity for retinoic acid receptors. As such, adapalene is less likely to be associated with certain local tolerability problems (e.g. burning, erythema, pruritus). Over the past 5 years, numerous clinical trials have been conducted to compare the efficacy and tolerability of adapalene and tretinoin in the treatment of acne vulgaris. Three pivotal, large, well-controlled studies involving almost 900 patients showed that adapalene gel 0.1% and adapalene solution 0.1% are at least as effective as tretinoin gel 0.025%, with superior local tolerability. Adapalene cream 0.1% has proven to be significantly more effective than vehicle, with response rates comparable to those observed with the gel and solution. A meta-analysis of trials with the gel formulation confirmed these findings, showing equivalent efficacy and improved tolerability vs. tretinoin gel 0.025%. Moreover, the onset of clinical effect was shown to be significantly more rapid than that of tretinoin gel. Taken together, these studies demonstrated that adapalene has overall efficacy similar to that of topical tretinoin, but with a superior therapeutic ratio that may result in superior outcomes in clinical practice through improved compliance. This may be expected because of its lesser potential for skin irritation, especially early in treatment, and because of greater convenience in that no waiting period is required between face washing and application of the product. Therefore, 5 years of clinical experience have established that adapalene in its various formulations is a valuable addition to current treatments for acne vulgaris.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Controlled Clinical Trials as Topic; Female; Follow-Up Studies; Humans; Male; Naphthalenes; Sensitivity and Specificity; Treatment Outcome; Tretinoin

Topical retinoids are a mainstay in the treatment of acne vulgaris. In the past these agents have been associated with irritant effects, however, newer generations of topical retinoids have emerged that have been designed to be less irritating. This paper focuses on the newer topical retinoid products, and specifically looks at adapalene and recent clinical studies that evaluate its efficacy and tolerability. Most of these studies evaluate adapalene in comparison with the new tretinoin formulations, which, like adapalene, have been designed to be less irritating than their predecessors. The various studies comparing the efficacy and tolerability of adapalene with the new formulations of tretinoin are described. A summary of the findings and their implications follows.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Controlled Clinical Trials as Topic; Female; Follow-Up Studies; Humans; Male; Naphthalenes; Probability; Treatment Outcome; Tretinoin

Although management of acne is sometimes difficult, primary care physicians can offer a number of treatment plans to patients with this skin condition. Comedonal acne usually responds to topical keratolytics, such as salicylic acid, benzoyl peroxide, adapalene, and tretinoin. Inflammatory acne is usually treated with topical therapy plus a systemic antibiotic. Nodulocystic acne generally requires an 8-week course of systemic antibiotics. If the nodulocystic acne does not improve, minocycline or isotretinoin may be needed. Topical therapy is often helpful in the long-term management of nodulocystic acne. New products are available that deliver topical agents in novel ways that decrease skin irritation. With the proper tools and instructions in use, most patients have significant improvement in their acne.

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Dermatologic Agents; Diagnosis, Differential; Drug Combinations; Drug Therapy, Combination; Humans; Keratolytic Agents; Tretinoin

The efficacy and tolerability of tazarotene 0.1% gel in the treatment of acne vulgaris have been compared with those of tretinoin 0.025% gel and adapalene 0.1% gel in multicenter, double-blind, randomized, parallel-group trials. Preliminary results from the tazarotene versus tretinoin trial suggest that once-daily tazarotene is more efficacious than once-daily tretinoin in reducing the numbers of papules and open comedones, and achieves a more rapid reduction in pustules. Both drugs appear to be equally efficacious against closed comedones. Preliminary results from the tazarotene versus adapalene trial suggest that, when tazarotene is applied only half as frequently as adapalene (every other day versus every day), the two drugs achieve comparable reductions in noninflammatory and inflammatory lesion counts. The results from these studies, and a separate split-face tolerability study, suggest that the tolerability of tazarotene gel is clinically comparable to that of tretinoin 0.025% gel, tretinoin 0.1% gel microsphere, and adapalene 0.1% gel.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Dermatologic Agents; Double-Blind Method; Gels; Keratolytic Agents; Multicenter Studies as Topic; Naphthalenes; Nicotinic Acids; Randomized Controlled Trials as Topic; Treatment Outcome; Tretinoin

Topics: Acne Vulgaris; Administration, Cutaneous; Administration, Oral; Anti-Bacterial Agents; Anti-Infective Agents; Humans; Isotretinoin; Retinoids; Tetracyclines; Tretinoin

Novel tretinoin cream and gel formulations have been developed that incorporate polyolprepolymer-2, which is a material designed to help retain drug molecules in and on the skin when applied in topical vehicles. The results of preclinical and clinical investigations have confirmed the beneficial impact of such a vehicle on tretinoin tolerability. In vitro studies with selected polyolprepolymer-containing formulations have reduced initial and cumulative tretinoin percutaneous penetration, and guinea pig studies showed that the gel formulation containing polyolprepolymer-2 caused less erythema and edema than did the corresponding commercially-available tretinoin gel formulation. Human studies with tretinoin containing polyolprepolymer-2 have consistently demonstrated a favorable tolerability profile when compared with commercially-available tretinoin. Use of the polyolprepolymer-2-containing tretinoin formulation in human studies has resulted in reductions in peeling--a problem commonly associated with use of standard tretinoin formulations. These reductions in irritation have not been at the expense of efficacy; acne clinical trial results indicate comparable effectiveness between tretinoin containing polyolprepolymer2 and commercially-available tretinoin.

Topics: Acne Vulgaris; Administration, Topical; Animals; Gels; Guinea Pigs; Humans; Keratolytic Agents; Ointments; Polypropylenes; Polyurethanes; Skin Tests; Tretinoin

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Gels; Humans; Keratolytic Agents; Naphthalenes; Nicotinic Acids; Ointments; Retinoids; Tretinoin

Topics: Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide; Humans; Inflammation; Keratolytic Agents; Risk Factors; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Humans; Keratolytic Agents; Tretinoin

Topics: Acne Vulgaris; Adult; Androgen Antagonists; Androgens; Contraceptives, Oral; Estrogens; Female; Humans; Keratolytic Agents; Tretinoin

A chemical peel is a procedure in which a topically applied wounding agent creates smooth, rejuvenated skin by way of an organized repair process. This article describes the indications, classifications, operative procedure, and complications of chemical resurfacing. In addition, alternatives to chemoexfoliation are discussed.

Topics: Acne Vulgaris; Administration, Topical; Chemexfoliation; Contraindications; Dermabrasion; Female; Humans; Hydroxy Acids; Laser Therapy; Male; Melanosis; Phenols; Preoperative Care; Skin Aging; Tretinoin; Trichloroacetic Acid

Apart from oral drug treatment, drug therapy in acne vulgaris comprises topical treatment with agents with a primarily keratolytic action (e.g. tretinoin and benzoylperoxide), and with antibiotics (clindamycin, erythromycin, and erythromycin-zinc complex). The acne grade in the particular patient usually determines the selection of the preferred route of administration, viz. topical or oral, or a combination of both, and topical treatment is usually preferred in mild to moderate acne. The fact that a topically applied compound may also become systemically available to a quantifiable extent, is not generally considered.. The present paper reviews the clinical data on transdermal uptake of anti-acne agents in man, also with respect to their relevance for daily clinical practice.. The majority of published data on transdermal penetration of topical anti-acne agents focuses on the retinoid tretinoin, and on the antimicrobial agent clindamycin. This interest emerges from the fact that these agents have been associated with embryotoxicity/teratogenicity, and pseudomembranous colitis, respectively. For both compounds the extent of systemic availability after topical application is low, viz. 5-7% and 8%, respectively, at its highest. The height and variability in endogenous retinoid levels is very likely to outweigh any contribution of exogenously applied tretinoin, but a full consensus on the safe use of topical tretinoin in pregnancy is still lacking. With respect to clindamycin, the suggested association between its topical use and the occurrence of pseudomembranous colitis appears not to be of clinical relevance. In order to reduce systemic exposure to clindamycin as much as possible, topical application of clindamycin phosphate is to be preferred over clindamycin hydrochloride salt. Regarding other topical anti-acne agents, it has been suggested that topical zinc-erythromycin is to be preferred over erythromycin, both from clinical efficacy and safety viewpoints. With respect to the currently used compounds like benzoylperoxide, azelaic acid, and adapalene, available clinical pharmacokinetic data are scarce, and significant safety concerns did not emerge as yet.. The limited transdermal uptake of topical anti-acne agents underpins their safe use in daily clinical practice. With respect to topical retinoids, formal consensus is lacking regarding their use in pregnancy.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Administration, Cutaneous; Administration, Oral; Anti-Bacterial Agents; Clindamycin; Dermatologic Agents; Drug Therapy, Combination; Enterocolitis, Pseudomembranous; Female; Humans; Keratolytic Agents; Pregnancy; Skin Absorption; Tretinoin

The purpose of this meta-analysis was to determine if adapalene 0.1% gel (Differin) provided superior efficacy and better tolerability than tretinoin 0.025% gel in the treatment of acne vulgaris. All comparative studies, both published and unpublished, from the United States and Europe, that fulfilled rigorous protocol criteria (multicentre, randomized, investigator-blind) were used. Five comparative studies met these criteria. In total, the meta-analysis evaluated 900 patients (450 treated with adapalene 0.1% gel, 450 treated with tretinoin 0.025% gel) with mild-to-moderate acne from the combined clinical trials. To avoid study bias, the meta-analysis used an intention-to-treat analysis. Statistical methodology for the meta-analysis included analysis of covariance, analysis of variance and Cochran-Mantel-Haenszel test. All statistical tests were two-sided, with the 0.05 probability level used to establish statistical significance, and 95% confidence intervals used to assess equivalence. Adapalene demonstrated equivalent efficacy to tretinoin in terms of reducing total lesion count. Adapalene demonstrated more rapid efficacy, as evidenced by a significant difference in the reduction of inflammatory and total lesions at week 1. Adapalene also demonstrated considerably greater local tolerability at all evaluation periods. The findings from this meta-analysis suggest that adapalene 0.1% gel constitutes a pharmacologic advance over such classic retinoids as tretinoin for the treatment of acne vulgaris.

Topics: Acne Vulgaris; Adapalene; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Drug Eruptions; Gels; Humans; Keratolytic Agents; Multicenter Studies as Topic; Naphthalenes; Randomized Controlled Trials as Topic; Treatment Outcome; Tretinoin

Acne is one of the most common diseases in dermatology. It is of considerable esthetic significance, which explains the mental stress in affected patients. Although acne almost always heals spontaneously in early adulthood, treatment measures can shorten the course, reduce the severity of the disease, and avoid complications such as scarring. Treatment has changed substantially in recent years. In accordance with pathogenic principles, effective treatment is possible. In most patients, a combination of drugs aimed at correcting abnormal keratinization and reducing the proliferation of Propionibacterium acnes is sufficient to control the disease. For more severely affected patients with no response to this approach, therapy to suppress sebum production is indicated. Of all therapeutic modalities available, only oral isotretinoin alters the natural course of the disease. In acne inversa, surgical management should be undertaken as early as possible.

Topics: Acne Vulgaris; Administration, Topical; Androgen Antagonists; Anti-Infective Agents, Local; Benzoyl Peroxide; Dermatologic Agents; Dicarboxylic Acids; Diuretics; Humans; Keratolytic Agents; Phototherapy; Tretinoin; Zinc

Acne is one of the most common and easily treated diseases of adolescents. Scarring can be prevented in most cases with early and vigorous treatment. But such treatment requires patience, skill, and a commitment to good counseling.

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Female; Humans; Isotretinoin; Keratolytic Agents; Male; Pediatrics; Primary Health Care; Tretinoin; Workforce

The treatment of acne is based upon simple pathogenic arguments, but needs to be adapted to the type of acne. Patients must always be informed that it is long and difficult and that no significant response will be expected before 2 to 3 months of regular treatment. The authors present the different therapeutic agents and strategies. Isotretinoin should be used only in severe acne after failure of at least 3 months of a well conducted classical treatment and in nodulo-cystic acne; because of its major side effect of teratogenicity its use in adolescent girl's requires pregnancy testings before and during treatment and an effective contraception.

Topics: Acne Vulgaris; Adolescent; Adult; Female; Humans; Keratolytic Agents; Male; Pregnancy; Pregnancy in Adolescence; Pregnancy Tests; Tretinoin

Topics: Acne Vulgaris; Administration, Cutaneous; Administration, Oral; Anti-Bacterial Agents; Benzoyl Peroxide; Drug Therapy, Combination; Hormones; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Dermatologic Agents; Hormones; Humans; Tretinoin

Topics: Acne Vulgaris; Administration, Cutaneous; Administration, Oral; Anti-Bacterial Agents; Humans; Tretinoin

Acne vulgaris is the clinical expression of inflammation of the pilosebaceous unit. Factors known to predispose to the development of acne include increased sebum, which is acted on by Propionobacterium acnes to generate inflammatory substances, and retention hyperkeratosis, which causes obstruction of the sebaceous follicle. Therapeutic modalities for acne include topical and systemic antibiotics, comedolytic agents (such as benzoyl peroxide and topical retinoids) and systemic retinoids. Acne scars may be treated surgically using procedures such as dermabrasion and dermal injections of bovine collagen or simple scar excision, scar punch elevation, or punch grafting.

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Cicatrix; Female; Humans; Male; Office Visits; Surgery, Plastic; Tetracycline; Tretinoin

Primary care physicians should be familiar with the effects and appropriate uses of retinoids. Topical tretinoin (Retin-A) can reverse photoaging of the skin, although some transient, undesirable side effects usually occur. In patients with acne vulgaris, topical tretinoin and systemic isotretinoin (Accutane) are the only agents that act upon the apparent underlying causes. Recurrence is unlikely after successful results are achieved. Chronic hypervitaminosis A presents insidiously, and physicians must maintain a high index of suspicion. Complete history taking should always include questions about the patient's use of vitamin supplements.

Topics: Acne Vulgaris; Administration, Topical; Animals; Drug Eruptions; Drug Therapy, Combination; Humans; Hypervitaminosis A; Isotretinoin; Medical History Taking; Physical Examination; Skin Aging; Skin Neoplasms; Tretinoin

In recent years, a greater understanding of the pathogenesis and improved treatment regimens have enhanced our ability to control this common and often distressing condition. The author presents a brief outline of its pathogenesis followed by a systematic approach to treatment.

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Causality; Clinical Protocols; Diagnosis, Differential; Family Practice; Female; Humans; Incidence; Male; Tretinoin

Acne vulgaris is a multifactorial disease involving abnormalities in follicular keratinization, sebum production, proliferation of Propionibacterium acnes, and inflammation. Treatment is directed toward reversing these underlying pathogenic factors. Therapeutic options include topical comedolytics, topical and systemic antibiotics, hormonal manipulations, and oral retinoids.

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Hormones; Humans; Infant; Infant, Newborn; Tretinoin

Acne is a skin disorder of the sebaceous follicles that commonly occurs in adolescence and young adulthood. The pathogenesis involves abnormal follicular hyperkeratosis and obstruction of the follicle, stimulation of sebaceous gland secretion by androgens, and proliferation of Propionibacterium acnes, which promotes inflammation. Treatment regimens should be designed based upon an understanding of the multifactorial basis of pathogenesis. Both topical and systemic agents may be employed to normalize keratinization, decrease sebaceous gland activity, decrease the follicular P. acnes population, and minimize inflammation.

Topics: Acne Vulgaris; Administration, Cutaneous; Administration, Oral; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Drug Therapy, Combination; Glucocorticoids; Humans; Isotretinoin; Sebaceous Glands; Tretinoin

Topics: Acne Vulgaris; Adolescent; Androgen Antagonists; Anti-Bacterial Agents; Female; Gram-Positive Bacterial Infections; Humans; Male; Propionibacterium acnes; Sebaceous Glands; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Humans; Keratosis; Pigmentation Disorders; Skin; Skin Neoplasms; Tretinoin

Acne vulgaris is a disease of the pilosebaceous unit that affects nearly all persons to some degree during the teenage years. It is a disease that should be treated because of the anxiety and disfigurement it causes in the affected patient. Acne therapy is directed against the three probable pathogenic processes in acne: (1) abnormal keratinization of the sebaceous follicle, (2) excessive production of sebum, and (3) proliferation of bacteria in the follicle. Superficial acne consisting of comedones and small papulopustules will frequently respond to topical therapy such as retinoic acid, benzoyl peroxide, and topical antibiotics. Deeper lesions require systemic antibiotics of which tetracycline is the drug of choice. Severe, recalcitrant cystic acne usually responds well to the oral retinoid, isotretinoin. The severe teratogenic effects of isotretinoin on a developing fetus make this a risky drug to prescribe for women with childbearing potential. In such cases the greatest precautions should be taken to avoid pregnancy during a course of isotretinoin. Such precautions include pregnancy testing, contraceptive counseling, and the use of at least two effective forms of birth control in sexually active women.

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Female; Humans; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Dermatologic Agents; Humans; Isotretinoin; Keratolytic Agents; Tretinoin

Retinoids, chemicals that have vitamin A activity, have become important therapeutic agents for a variety of cutaneous disorders, including acne. This paper reviews the history of retinoid use in acne, including retinol, topical tretinoin, topical and systemic isotretinoin, systemic etretinate, and new investigational retinoid molecules.

Topics: Acne Vulgaris; Humans; Isomerism; Isotretinoin; Retinoids; Tretinoin; Vitamin A

Dermatologists frequently are consulted by a pregnant patient or a woman of childbearing age who desires acne therapy. Because there are no published studies in which women took acne medications throughout pregnancy, information about safety must be obtained indirectly from studies in which the agents were taken for another indication during some portion of pregnancy. Oral tetracycline is associated with maternal liver toxicity and deciduous tooth staining in the infant, and tetracycline occasionally has been associated with other congenital anomalies. Maternal isotretinoin ingestion is associated with major craniofacial and cardiac deformities, as well as other congenital anomalies. Erythromycin, however, appears to be safe. Topical acne medications never have been implicated as a cause of fetal deformities in human beings. Dermatologists should be aware of potential toxic and teratogenic effects of acne medicines before prescribing them to women of childbearing age. Prompt reporting of adverse effects is encouraged.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Administration, Cutaneous; Administration, Oral; Benzoyl Peroxide; Clindamycin; Erythromycin; Female; Humans; Pregnancy; Pregnancy Complications; Salicylates; Tetracyclines; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Cyproterone; Female; Humans; Isotretinoin; Male; Tretinoin

The management of skin disease may differ in different parts of the world, but in most countries, acne should be a most treatable disease. Acne therapy has not evolved in the most logical fashion, but this article reviews our demonstration of risk factors in the treatment of acne. Young patients, male patients, truncal acne, a marked seborrhea, and a low dose (500 mg/day or less) of tetracycline are factors associated with a poorer response and, when oral therapy is stopped, a greater relapse rate. One gram a day of tetracycline, given for 6 months, is the minimum course of oral therapy and should be given along with topical therapy. One of the most widely used topical treatments is benzoyl peroxide, and this presentation was given in honor of Dr. William Pace, who was possibly the first dermatologist to be aware of the benefit of benzoyl peroxide--a fact not adequately recorded in dermatologic history. A small number of patients do not respond well to conventional therapy, but alternative treatments should bring about a successful outcome. Alternative treatments include hormonal therapy (i.e., 2 mg cyproterone acetate plus 50 micrograms ethinyl estradiol; spironolactone, 100 mg twice daily; or isotretinoin, 1 mg/kg). The success of all these treatments bears some relationship to their effect in modulating the etiologic factors of acne: an enhanced sebum production, increased ductal cornification, abnormal bacterial colonization, and the production of inflammation. Isotretinoin is the most beneficial of all drug regimens, and this fact no doubt relates to its favorable effect on all etiologic factors.

Topics: Acne Vulgaris; Benzoyl Peroxide; Dose-Response Relationship, Drug; Erythromycin; Female; Humans; Male; Tetracycline; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Animals; Female; Humans; Infant, Newborn; Isotretinoin; Kinetics; Precancerous Conditions; Pregnancy; Skin Neoplasms; Tretinoin

Acne vulgaris is a common skin disorder. Although it is most prevalent in the second decade of life, its beginnings are heralded by increased activity of the sebaceous glands and faulty follicular keratinization, which are already evident in mid to late childhood. The subsequent and increasing proliferation of the follicular anaerobic diphtheroid microflora contribute further as an important pathogenic factor in the generation of inflammatory lesions. Treatments of acne, therefore, are aimed at reducing the follicular anaerobic bacteria, counteracting the follicular hyperkeratosis, and inhibiting the activity of sebaceous glands.

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Anti-Infective Agents, Local; Bacterial Infections; Benzoyl Peroxide; Child; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Isomerism; Isotretinoin; Keratosis; Male; Propionibacterium acnes; Sebaceous Glands; Sebum; Tretinoin; Triamcinolone Acetonide

Topics: Acne Vulgaris; Aging; Dose-Response Relationship, Drug; Drug Evaluation; Humans; Isomerism; Isotretinoin; Recurrence; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Benzoyl Peroxide; Clindamycin; Dicarboxylic Acids; Erythromycin; Humans; Miconazole; Oxytetracycline; Salicylates; Salicylic Acid; Tretinoin

Topics: Acne Vulgaris; Androgen Antagonists; Androgens; Benzoyl Peroxide; Cyproterone; Cyproterone Acetate; Dermatitis, Seborrheic; Drug Combinations; Erythromycin; Ethinyl Estradiol; Female; Humans; Isotretinoin; Male; Propionibacterium acnes; Sebum; Tetracycline; Tretinoin

The potential of vitamin A, or retinol, in the treatment of a variety of skin diseases has long been recognized, but because of serious toxic effects this substance generally could not be used. The recent development and marketing of two relatively non-toxic synthetic analogues, which are known as retinoids, has made it possible to treat some of the diseases that are resistant to standard forms of therapy. Isotretinoin is very effective in cystic and conglobate acne, while etretinate is especially useful in the more severe forms of psoriasis. Good results have also been obtained in other disorders of keratinization. Vitamin A and its derivatives apparently have an antineoplastic effect as well and may come to be used in both the prevention and the treatment of epithelial cancer. In many of these diseases the retinoids act by enhancing the normal differentiation and proliferation of epidermal tissues, but the exact mechanisms are not well understood. Their influence on the intracellular polyamines that control the synthesis of nucleic acids and proteins may be an important factor. Although the retinoids have few serious systemic effects, they are teratogenic, and because they persist in the body their use in women of childbearing potential is limited.

Topics: Acne Vulgaris; Bone Diseases; Chemical and Drug Induced Liver Injury; Etretinate; Female; Humans; Isomerism; Isotretinoin; Keratosis; Kinetics; Psoriasis; Skin Diseases; Skin Neoplasms; Tretinoin; Triglycerides; Vitamin A

The retinoids are synthetic derivatives of vitamin A. Isotretinoin (13-cis-retinoic acid) is now being widely used in the United States for severe acne and etretinate is available in Europe and other countries for psoriasis. These drugs are also effective for a number of other skin diseases. This is an attempt to review basic knowledge of retinoids with which the practicing dermatologist should be familiar, to review the current status of studies, and to speculate on the present and future roles of these drugs in dermatology.

Topics: Acne Vulgaris; Etretinate; Humans; Inflammation; Isotretinoin; Keratins; Psoriasis; Retinoids; Sebum; Skin Diseases; Skin Neoplasms; Sweat Gland Diseases; Tretinoin; Vitamin A

Acne is an ubiquitous problem of adolescence. Currently available medications have improved the effectiveness of therapy. Pediatricians should be able to manage most of their patients with acne without referral to dermatologists. The exact pathogenesis of this disorder is not known, but a working hypothesis encompassing the factors involved allows a more rational approach to therapy. Successful treatment not only requires familiarity with the various types of acne lesions and the medications of choice, but an ability to recruit the patient into a partnership of therapy. The more the patient understands about the disorder the better the compliance and chances for success.

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Bacterial Physiological Phenomena; Benzoyl Peroxide; Dihydrotestosterone; Humans; Patient Education as Topic; Retinoids; Sebaceous Glands; Sebum; Tretinoin

Approximately 120,000 women of childbearing age used isotretinoin in the first 16 months after its release for the treatment of cystic acne. In September, 1983, the American Academy of Dermatology requested its members to relate the outcome of pregnancies of women inadvertently exposed to isotretinoin ( Accutane ) during pregnancy to its Adverse Drug Reaction Reporting System ( ADRRS ). Of nine pregnancies reported, seven ended in spontaneous abortion or the birth of an infant with birth defects. Of thirty-five pregnancies with isotretinoin exposure reported to the ADRRS or the U.S. Food and Drug Administration, twenty-nine (83%) resulted in spontaneous abortion or infants with birth defects. The most frequently reported severe birth defects involved the central nervous system (microcephaly or hydrocephalus) and the cardiovascular system (anomalies of the great vessels). Microtia or absence of external ears were also noted in a majority of cases. These findings illustrate the usefulness of specialty-based reporting of adverse drug effects and emphasize the teratogenic risk of isotretinoin in humans. Physicians need to fully and carefully inform women of childbearing age of these risks.

Topics: Abnormalities, Drug-Induced; Abortion, Spontaneous; Acne Vulgaris; Female; Heart Defects, Congenital; Humans; Hydrocephalus; Infant, Newborn; Isotretinoin; Microcephaly; Pregnancy; Pregnancy Complications; Pregnancy Trimester, First; Tretinoin

Isotretinoin is a new orally active retinoic acid derivative for the treatment of severe refractory nodulocystic acne. The pharmacological profile of isotretinoin suggests that it acts primarily by reducing sebaceous gland size and sebum production, and as a result alters skin surface lipid composition. Bacterial skin microflora is reduced, probably as a result of altered sebaceous factors. Isotretinoin 1 to 2 mg/kg/day for 3 to 4 months produces 60 to 95% clearance of inflammatory lesions in patients with severe, recalcitrant nodulocystic acne, with evidence of continued healing and prolonged remissions in many patients after treatment withdrawal. Doses as low as 0.1 mg/kg/day have also proven successful in the clearance of lesions; however, with such low doses the duration of remission after discontinuation of therapy is usually shorter. Encouraging results have also been seen in small numbers of patients with rosacea, Gram-negative folliculitis, Darier's disease, ichthyosis and pityriasis rubra pilaris, the response in keratinising disorders resembling that with the related drug etretinate. While long term follow-up studies in these patients have not been reported, prolonged remission after withdrawal of isotretinoin in disorders of keratinisation is unlikely, as with other drugs used in these conditions. Isotretinoin is only partially effective in psoriasis, in contrast to etretinate which is very effective in psoriasis but ineffective in severe acne. Some encouraging results have also been reported with isotretinoin in patients with squamous and basal cell carcinomas, but isotretinoin has proven unsuccessful in non-squamous cell epithelial and non-epithelial cancer. Side effects affecting the mucocutaneous system occur in nearly all patients receiving isotretinoin, but rarely lead to drug withdrawal. Raised serum triglyceride levels are also commonly reported. The possibility of long term spinal or skeletal bone toxicity may restrict the use of isotretinoin in severe disorders of keratinisation requiring prolonged administration. Isotretinoin is strictly contraindicated in women of childbearing potential due to its severe teratogenic properties, unless an effective form of contraception is used. Thus, isotretinoin offers an effective advance on the treatment options available in a difficult therapeutic area - those patients with severe, nodulocystic acne not responding to 'traditional' therapy.

Topics: Acne Vulgaris; Animals; Anti-Inflammatory Agents; Carcinogens; Cell Differentiation; Cell Division; Humans; Immunity; Isotretinoin; Kinetics; Mutagens; Psoriasis; Rosacea; Sebaceous Glands; Skin; Skin Absorption; Skin Diseases; Skin Neoplasms; Teratogens; Tissue Distribution; Tretinoin

Topics: Acne Vulgaris; Adolescent; Child; Child, Preschool; Darier Disease; Etretinate; Female; Humans; Ichthyosis; Infant; Isomerism; Isotretinoin; Keratins; Keratoderma, Palmoplantar; Male; Pityriasis Rubra Pilaris; Psoriasis; Skin Diseases; Skin Diseases, Vesiculobullous; Tretinoin

Isotretinoin, an isomer of retinoic acid, recently has been approved by the Food and Drug Administration for treatment of severe, recalcitrant acne. The most impressive effects include inhibition of sebum production and a reversible decrease in sebaceous gland size. Isotretinoin has proved to be an effective drug; response to therapy has been seen in virtually 100 percent of patients treated. Almost all patients experience reversible cutaneous and mucous-membrane symptoms while on isotretinoin treatment. Other common side effects include conjunctivitis (38 percent) and eye irritation (50 percent). The recommended dosage is 1-2 mg/kg/d for no longer than 16 weeks. Isotretinoin is currently the treatment of choice for severe, recalcitrant acne; however, because of potential side effects associated with retinoids, isotretinoin should be reserved for those patients who are unresponsive to conventional therapy, including topical and systemic antibiotics.

Topics: Acne Vulgaris; Clinical Trials as Topic; Eye; Humans; Intestinal Absorption; Isotretinoin; Sebum; Tissue Distribution; Tretinoin; Triglycerides

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Capsules; Child; Clindamycin; Erythromycin; Gels; Humans; Isotretinoin; Tretinoin; Zinc

Etretinate (Ro 10-9359) is a new aromatic retinoic acid derivative for the treatment of severe psoriasis and other dyskeratoses. The pharmacological profile of etretinate suggests that it acts by normalizing pathological changes in epidermal and dermal skin, particularly inhibiting hyperkeratinization and cell differentiation, although its specific mode of action in different disorders remains to be elucidated. Etretinate is rapidly and presystemically metabolised to an active metabolite which appears in plasma at about the same time as parent drug. A 'deep' storage compartment with a very extended elimination half-life gives rise to detectable plasma levels of drug for at least 3 to 4 months after discontinuation of long term therapy. Studies suggest that etretinate at an initial dose of 1 mg/kg/day, reducible during maintenance therapy, is an effective alternative to PUVA and other conventional therapy in severe psoriasis. Its greatest immediate value is in the control of eruptive and treatment-resistant psoriasis, and in its potential for use in combination with other therapy to improve the response. In Darier's disease it appears to be the treatment of choice, and preliminary studies also suggest its usefulness in ichthyosis, and most other dyskeratoses and possibly in basal cell carcinoma. Side effects affecting the mucocutaneous system occur in nearly all patients, but rarely lead to drug withdrawal. When withdrawal does become necessary, the primary reason is usually hair loss. A few paradoxical observations of raised and lowered liver enzyme levels have been reported, and also a few cases of suspected liver damage. Etretinate is strictly contraindicated in women of child-bearing potential due to its severe teratogenic properties.

Topics: Acne Vulgaris; Alanine Transaminase; Antineoplastic Agents; Cell Division; Etretinate; Humans; Lipids; Liver; Neoplasms, Experimental; Psoriasis; PUVA Therapy; Skin; Skin Diseases; Tretinoin

Topics: Acne Vulgaris; Androgen Antagonists; Androgens; Anti-Bacterial Agents; Bacterial Infections; Benzoyl Peroxide; Dapsone; Dermatologic Agents; Dihydrotestosterone; Fatty Acids, Nonesterified; Female; Humans; Male; Propionibacterium acnes; Sebum; Sunlight; Tretinoin

In the one year since isotretinoin has been available in the United States for the treatment of severe, recalcitrant, nodulocystic acne, there has been extensive clinical verification of the reports of its dramatic efficacy in the treatment of this troublesome disease. Proper selection of patients, as well as treatment with adequate doses of drug for 3 to 5 months, will most often result in significant clinical improvement or total clearing. Although dosages of less than 1 mg/kg/day may produce a nearly equivalent degree of improvement with somewhat fewer or less severe side effects, the recommended daily dose remains 1 mg/kg/day because lower dosages are associated with more frequent relapses. In severe cases, the daily dosage may be increased to 2 mg/kg/day. Teratogenicity, elevation of serum triglycerides, liver function abnormalities, pancreatitis, and pseudotumor cerebri may all be associated with isotretinoin therapy and require close monitoring of the patient.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Adolescent; Adult; Animals; Central Nervous System; Chemical and Drug Induced Liver Injury; Folliculitis; Humans; Isotretinoin; Middle Aged; Mucous Membrane; Musculoskeletal System; Rats; Skin Diseases; Sweat Gland Diseases; Tretinoin

The synthetic retinoids are a new class of drugs which are highly effective in the treatment of a broad spectrum of dermatologic disease. In this report 15 patients with chronic disorders of keratinization and one patient with severe cystic acne were treated with oral isotretinoin. The degree of clinical response and duration of post-treatment remission varied with the different disorders. Acute side effects were predominantly limited to the skin and mucous membranes and were reversible after discontinuation of treatment in these patients. Acute retinoid toxicity and the potential for developing chronic toxicity are reviewed. In an attempt to facilitate the monitoring of dermatologic patients treated with oral synthetic retinoids, we present our current guidelines for the use of these agents.

Topics: Acne Vulgaris; Adolescent; Animals; Bone Diseases; Child; Child, Preschool; Etretinate; Humans; Isomerism; Isotretinoin; Joint Diseases; Keratosis; Mice; Psoriasis; Skin Diseases; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Dermatitis, Exfoliative; Half-Life; Humans; Ichthyosis; Isotretinoin; Neoplasms; Pityriasis Rubra Pilaris; Psoriasis; Tretinoin

Topical vitamin A acid (VAA) has various mechanisms of action which may be responsible for its therapeutic success in many different disorders. Although the absorption, metabolism, and excretion of VAA are not completely understood, VAA appears to remain mainly on the skin surface. The question of carcinogenicity is unresolved, and more research is needed to clarify this problem. This article reviews the literature regarding the therapeutic uses of VAA and summarizes various investigators' experiences with VAA.

Topics: Acne Vulgaris; Animals; Callosities; Cocarcinogenesis; Fox-Fordyce Disease; Humans; Ichthyosis; Keloid; Keratoacanthoma; Keratosis; Lichen Planus; Melanoma; Melanosis; Molluscum Contagiosum; Nevus; Psoriasis; Skin Absorption; Skin Diseases; Skin Neoplasms; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Anti-Infective Agents, Local; Humans; Sebum; Tretinoin

Although the basic cause of acne vulgaris remains unknown, considerable data that concern its pathogenesis and that have been accumulated in recent years allow a rational and therapeutically successful approach to the management of this disorder. To date, there is no single treatment for acne. Therapy must be individualized, with appropriate variations and modifications as the degree or severity of this disorder fluctuates. Today, this goal can be achieved by proper selection of available medications, coupled with the cooperation of the patient, and the knowledge, continued interest, and enthusiasm of the physician and his staff.

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Diet; Drug Therapy, Combination; Estrogens; Female; Humans; Male; Salicylates; Tretinoin; Zinc

Topics: Acne Vulgaris; Adolescent; Adult; Age Factors; Aged; Anti-Bacterial Agents; Child; Child, Preschool; Dermatologic Agents; Diagnosis, Differential; Female; Humans; Infant; Infant, Newborn; Male; Middle Aged; Sebaceous Glands; Sebum; Skin Diseases; Tretinoin; Vitamin A

Several pathogenetic factors contribute to the development of acne vulgaris. These include genetic predisposition, hormonal influences, increasing sebaceous secretion, bacterial colonization of the follicle and keratinization defects in the follicular epithelium. Modern acne therapy can take specific forms on the basis of recent research on pathogenesis. Sebostatic therapy can be performed by the topical application of benzoyl peroxide or the systemic administration of hormones (oestrogens, antiandrogens). Local treatment with retinoic has proved optimal in achieving a comedolytic effect. Moreover, the long-term use of antibiotics--tetracyclines, erythromycin systemically or benzoyl peroxide topically--is beneficial in respect to a reduction in Propionibacterium acnes. Experiments with immunological therapy are still in the early stages. Optimum results are obtained by the rational combination of several therapeutic modalities adapted to the type of acne to be treated.

Topics: Acne Vulgaris; Androgen Antagonists; Bacterial Vaccines; Benzoyl Peroxide; Cyproterone; Erythromycin; Estrogens; gamma-Globulins; Levamisole; Propionibacterium; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Animals; Female; Haplorhini; Humans; Maternal-Fetal Exchange; Mice; Pregnancy; Rats; Skin Diseases; Tretinoin; Vitamin A

Vitamin A acid (retinoic acid: tretinoin) is a vitamin A derivative used in the topical treatment of acne. It acts by 'unseating' comedones, improvement developing slowly over a period of 2 to 3 or more months, and is also said to prevent the formation of new lesions. About three-quarters of patients with acne vulgaris benefit from treatment. In controlled studies, results achieved after a 3 to 4 months course of treatment were superior to those with sulphur-resorcinol-salicylic acid. When compared with benzoyl peroxide, results were variable and appear to depend on the length of treatment, the types of formulations used, and the concentrations compared. Application of vitamin A acid should be continued until the patient has been free of new lesions for several months. Further continued application at a less frequent interval or using a less active dosage form may help to prevent exacerbations of acne. A systemic antibacterial agent such as tetracycline can be given as well as in patients with moderate to severe lesions. Vitamin A acid is used in conjunction with gentle washing (to remove surface oil) but should be applied to a dry skin to avoid unnecessary irritation. Patient education and encouragement are crucial during the initial phase of treatment when microcomedones may be converted to pustules prior to desquamation.

Topics: Acne Vulgaris; Humans; Kinetics; Liver; Prostaglandins; Skin; Skin Absorption; Skin Diseases; Steroids; Tretinoin; Vitamin A

The successful management of acne involves a careful detailing of the factors involved in pathogenesis to ensure confidence and co-operation with the now quite successful therapeutic measures available.

Topics: Acne Vulgaris; Anti-Bacterial Agents; Anti-Infective Agents, Local; Cosmetics; Diet; Drug Resistance; Emotions; Hormones; Humans; Sebum; Skin Absorption; Tranquilizing Agents; Tretinoin; Ultraviolet Therapy

Topics: Acne Vulgaris; Adolescent; Cacao; Child; Corynebacterium; Corynebacterium Infections; Diet; Female; Hair; Humans; Inflammation; Male; Rupture, Spontaneous; Sebaceous Glands; Sebum; Skin; Sulfur; Tetracyclines; Tretinoin

Topics: Acne Vulgaris; Anti-Bacterial Agents; Hormones; Humans; Male; Tetracyclines; Tretinoin

The future of a drug depends upon what it can do in the hands of the practitioner. Medicine is practiced on the basis of probabilities, and treatment must be selected which has the best chance of helping the patient, with the least amount of harm. There are many new drugs available for dermatologic therapy in other developed countries which are not available in this country, due to peculiarities of federal drug regulations.

Topics: Acne Vulgaris; Adrenal Cortex Hormones; Antifungal Agents; Antineoplastic Agents; Carotenoids; Dermatologic Agents; Fluorouracil; Herpesviridae Infections; Humans; Keratolytic Agents; Photosensitivity Disorders; Psoriasis; Skin Diseases; Tretinoin; United States; United States Food and Drug Administration; Vitamin E; Vitiligo

Benzoyl peroxide and tretinoin are commonly prescribed acne treatments. Historically, they have been difficult to combine in a single formulation due to chemical instability, and both medications are potentially irritating. Microencapsulation helps overcome these challenges.. Examine efficacy, safety, and tolerability of encapsulated BPO/encapsulated tretinoin (E-BPO/T) cream, 3%/0.1%.. Subjects ≥9 years old with moderate to severe acne were enrolled in 2 multicenter, double-blind, vehicle-controlled, parallel trials and randomized (2:1) to 12 weeks of once-daily E-BPO/T (n = 571) or vehicle cream (n = 287).. E-BPO/T was significantly superior to vehicle in both studies, with more subjects achieving IGA success with E-BPO/T (38.5%/25.4%) versus vehicle (11.5%/14.7%; P < .001/P = .017). The change from baseline in inflammatory lesion count for E-BPO/T was -21.6 versus -14.8 for vehicle (P < .001) in study 1 and -16.2 versus -14.1 (P = .018) in study 2. The changes from baseline in noninflammatory lesions for E-BPO/T were -29.7 versus -19.8 for vehicle (P < .001) and -24.2 and -17.4 (P < .001) in studies 1 and 2, respectively. E-BPO/T was well tolerated in both studies.. Long-term data are not available.. E-BPO/T provided statistically significant and clinically relevant improvements in IGA and inflammatory and noninflammatory lesion counts and was well tolerated in subjects with moderate to severe acne.

Topics: Acne Vulgaris; Administration, Cutaneous; Benzoyl Peroxide; Child; Dermatologic Agents; Double-Blind Method; Drug Combinations; Emollients; Humans; Immunoglobulin A; Treatment Outcome; Tretinoin

There is increasing interest in non-invasive options for chest rejuvenation with minimal to no downtime. Topical retinoids have long been used to correct photoaging due to their ability to promote epidermal hyperplasia, matrix metalloproteinase inhibition, collagen synthesis, and dispersion of melanin granules. Topical retinoid use is often limited by the ensuing irritation that occurs with initial use and resolves after about one month. Vehicle of delivery is a key factor to consider in order to minimize irritation and increase patient satisfaction. Micronized tretinoin 0.05% suspended in a polymer emulsion of hydrating ingredients (sodium hyaluronate, soluble collagen, and glycerin) is designed to aid in reducing irritation while ensuring uniform drug delivery.. The primary objective of our study is to evaluate the safety, efficacy, and patient satisfaction of tretinoin 0.05% lotion for nonprocedural photorejuvenation of the chest.. A total of 29 patients completed the trial, average age of 54.42 years (37-66 years old), Fitzpatrick II-IV skin types. Both the active and vehicle groups showed 30-40% improvement at day 180 according to the blinded evaluator mean percent improvement. Investigator global aesthetic improvement scale also trended towards improvement in both groups, with most patients exhibiting "improvement." Both the active and vehicle groups showed a significant change over time according to the nine-point photodamage and wrinkling scale, P<0.001 and P=0.007 (single factor ANOVA), respectively. The Fabi Bolton Wrinkle Scale also demonstrated improvement from screening to day 180; however, there was no statistical significance at any time point. At day 90, the active group had statistically significantly more erythema than the vehicle group (P<0.001), although both groups were only mild. At day 180, erythema decreased in both groups with the active group being similar to the vehicle group, 0.50±0.73 versus 0.09±0.30, respectively. Subjects in both the active and vehicle groups were equally satisfied at day 180, (2.38±1.15 in the active group versus 2.30±1.16 in the treatment group), with most subjects feeling "satisfied" with their results by day 180. This was also reflected in the subject global aesthetic improvement scale with most subjects noting noticeable improvement in the appearance of their chest from day 30 to day 180.. Tretinoin 0.05% lotion delivered in a proprietary blend of hydrating ingredients offers a safe and efficacious option that has minimal downtime for patients seeking non-procedural photo-rejuvenation of the chest. The proprietary vehicle, containing hyaluronic acid, glycerin, and collagen, was crucial in minimizing irritation and producing at least a one-point improvement according to the 9 point photodamage scale and 30-40% improvement in photodamage as noted by the blinded evaluator percent improvement score in both the vehicle and active groups. J Drugs Dermatol. 2022;21(6):645-652. doi:10.36849/JDD.6658.

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Aged; Double-Blind Method; Emollients; Emulsions; Glycerol; Humans; Hyaluronic Acid; Middle Aged; Patient Satisfaction; Prospective Studies; Quality of Life; Rejuvenation; Severity of Illness Index; Skin Aging; Treatment Outcome; Tretinoin

Topical retinoids like tretinoin are a mainstay of acne treatment but associated cutaneous irritation and drying may lead to poor adherence. As vehicle optimization can improve patient preference and adherence, tretinoin 0.05% lotion (Altreno®) was formulated using polymeric emulsion technology for uniform delivery of micronized tretinoin and moisturizing/hydrating excipients. This study compared tolerability and participant preference of a branded tretinoin 0.05% lotion versus generic cream.. In this single-center, double-blind, split-face study, 25 adult females with acne were randomized to apply lotion and cream to opposite cheeks once daily for 2 weeks. Investigator-assessed skin irritation and appearance, as well as participant ratings of the products and skin sensations, were evaluated immediately after first use and after 2 weeks.. At week 2, there was significantly greater erythema, scaling, and dryness (122%–144%; P<0.01 each) and decreased skin softness, smoothness, radiance, and brightness (~40% difference; P<0.01 each) on the cream-treated versus lotion-treated side of the face. More participants agreed that the lotion was gentle, comfortable/soothing, spreadable, absorbent, not sticky, and left minimal residue versus cream (range: 72%–92% vs 8%–36%). Agreement scores on skin sensations (eg, soft, not dry, less dull) were similarly higher for lotion versus cream. Overall, ~70% of participants preferred to take home the lotion over the cream.. After 2 weeks of once-daily use, tretinoin 0.05% lotion was associated with less irritation and superior skin appearance/ sensation versus generic 0.05% cream, with most participants preferring the lotion over cream. These results demonstrate the importance of a well-designed vehicle formulation on tolerability and patient preference. J Drugs Dermatol. 2022;21(8): 875-880. doi:10.36849/JDD.6945.

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Double-Blind Method; Drugs, Generic; Emollients; Emulsions; Excipients; Female; Humans; Keratolytic Agents; Patient Preference; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome; Tretinoin

Here, we assessed the efficacy and safety of Nano lipid carrier (NLC) drug delivery system containing tretinoin (NLC-TRE) in comparison with the conventional 0.05% tretinoin cream (TRE cream) in mild to moderate acne vulgaris. A stable and appropriate NLC-TRE formulation was prepared using a high-pressure homogenizer and particle characterization and physicochemical properties were evaluated under accelerated conditions. Efficacy assessment was performed via a split-face clinical study, by comparing the number of acne lesions, porphyrin production and skin biophysical parameters in both sides of the face randomly treated with NLC-TRE and TRE cream. Plasma concentration of tretinoin after topical application of NLC-TRE was measured for primary safety evaluation. We acquired a stable, spherical nanoparticles with particle size of 118.5 nm, PI equal to 0.485 and ZP of - 44.7 mV. The rate of decrease of acne lesions was significantly higher in NLC- TRE side (p value < 0.001). The size and intensity of porphyrin production in pilosebaceous follicles were significantly reduced only on NLC-TRE side (p value < 0.01). The plasma concentration of the tretinoin, after 8 weeks' application remained lower than the toxic levels. The NLC-TRE formula provides better efficiency and good loading capacity of TRE in the drug delivery system.

Topics: Acne Vulgaris; Double-Blind Method; Drug Carriers; Humans; Porphyrins; Skin; Tretinoin

There is an unmet need for topical treatments with good tolerability in management of acne vulgaris. The present study aimed to evaluate efficacy and safety of a novel tretinoin (microsphere, 0.04%) formulation in combination with clindamycin (1%) gel for treatment of acne vulgaris.. This phase 3 randomized, double-blind study included patients with moderate-to-severe acne. Patients were treated with tretinoin (microsphere, 0.04%) + clindamycin (1%) or one of the monotherapies (tretinoin, 0.025%; clindamycin, 1%). Key endpoints included percent change in lesion counts, and improvement in Investigator's Static Global Assessment (ISGA) score.. 750 patients were randomized (combination,. The once-daily, microsphere-based formulation was generally tolerable with a positive impact on therapeutic outcomes and patients' compliance.. CTRI/2014/08/004830.

Topics: Acne Vulgaris; Clindamycin; Double-Blind Method; Drug Combinations; Gels; Humans; Microspheres; Treatment Outcome; Tretinoin

Retinoids and antibiotics topical treatments are commonly used as first line therapy in mild to moderate acne. However, irritant contact dermatitis is a common side effect of topical retinoids. A strategy to increase local tolerability is the "short contact therapy" (SCT) approach, consisting in the application of the product with the complete removal after 30 to 60 minutes using a non-aggressive cleanser. A gel containing tretinoin 0.02%, clindamycin 0.8%, and glycolic acid 4% in polyvinyl alcohol (MP-gel) has shown to be effective as monotherapy in mild to moderate acne with a tolerability profile similar to other topical retinoids. So far, no trials have been performed with this gel comparing the tolerability profile of SCT with standard application therapy (SAT). We conducted a 2-center randomized parallel groups, controlled, assessor-blinded study, comparing MP-gel applied as SCT in comparison with MP-gel used as SAT (The "MASCOTTE" trial). Forty-six subjects (nine men and 37 women, mean age 23 ± 4 years, range 18-31 years) with mild-to-moderate acne were enrolled, after their written informed consent in a randomized, parallel groups controlled, assessor-blinded 8-week trial. Twenty-three were assigned to MP-gel once daily (evening application) using the SCT approach (ie, complete removal of product after 1 hour using a gentle cleanser), and 23 were randomized to the SAT approach with the same gel. The primary endpoint was the evolution of the tolerability score (TS) assessed evaluating four items: erythema, dryness, stinging, and burning, using a 4-point score scale (from 0: no symptom to 3: severe symptom). Secondary endpoints were the evolution of global acne grading system (GAGS) score (range: from 0 to >39) and the investigator global assessment (IGA of acne severity) score (range from 0 to 4). TS was evaluated at 2, 4, and 8 weeks. GAGS and IGA scores were evaluated at baseline and at week eight. At week eight, an efficacy global score (EGS) (from 1: no efficacy to 4: very good efficacy) and a tolerability global score (TGS) (from 1: very low tolerability to 3: very good tolerability) evaluation were also done. All the evaluations were performed by an investigator unaware of treatment groups allocation (SCT or SAT). Thirty-eight subjects (83%) completed the 8-week treatment period. Eight subjects (two in the SCT group and six in the SAT group) dropped out prematurely due to low skin tolerability. In the SCT the TS at week two was 1.3 ± 1.7, in

Topics: Acne Vulgaris; Adolescent; Adult; Clindamycin; Dermatologic Agents; Female; Gels; Glycolates; Humans; Male; Treatment Outcome; Tretinoin; Young Adult

Acne vulgaris is the most common dermatological disorder worldwide, causing significant physical and psychological morbidity. Topical combination therapy has shown superior efficacy compared to monotherapy, especially when combined with retinoids. Few studies have directly compared combined formulations. This evaluator-blinded pilot study compared the efficacy and tolerability of two marketed topical combination acne gels, clindamycin 1%-tretinoin 0.025% (CT) and benzoyl peroxide 2.5%-adapalene 0.1% (BA) in 20 patients with mild to moderate acne vulgaris. Gels were applied daily on opposite sides of the face for 21 days. The primary outcome was difference in transepidermal water loss (TEWL) at the end of treatment. Secondary endpoints were skin moisture content measurement, Investigators' Global Assessment, subject self-assessments (SSA) of burning/stinging, itching, erythema, and dryness/scaling, and Comparative Participant Satisfaction Questionnaire (CPSQ). Efficacy was assessed by inflammatory and non- inflammatory acne efflorescences counts. TEWL increased significantly for both CT and BA (+57.74%, P=0.002; +58.77%, P<0.001); skin moisture content significantly decreased only for BA (-16.47%, P=0.02). Only BA showed a significant increase in erythema and dryness/scaling (P=0.027 and P=0.014) and in SSA burning/stinging (P=0.04). Patient satisfaction evaluation also reflected the strong BA irritation. Although CT and BA both reduced acne lesions (P<0.001) and more patients preferred to continue with CT, subject perception of acne improvement was higher for BA. These findings suggest that CT and BA have similar efficacy in the treatment of mild to moderate papulopustular acne. However, CT was better tolerated than BA by both medical and subject evaluation. CT is an effective and tolerated treatment option.J Drugs Dermatol. 2021;20(3):295-301. doi:10.36849/JDD.2021.5641.

Topics: Acne Vulgaris; Adapalene, Benzoyl Peroxide Drug Combination; Administration, Cutaneous; Adolescent; Adult; Clindamycin; Dermatologic Agents; Drug Combinations; Erythema; Female; Gels; Humans; Male; Patient Satisfaction; Pilot Projects; Pruritus; Severity of Illness Index; Skin; Treatment Outcome; Tretinoin; Water Loss, Insensible; Young Adult

In two phase III clinical trials of patients with moderate-to-severe acne (NCT02932306, NCT02965456), tretinoin 0.05% lotion reduced inflammatory and noninflammatory lesions relative to vehicle lotion, with low potential for cutaneous irritation.. Data from these studies were analyzed post hoc to investigate the effects of tretinoin 0.05% lotion on patient-reported quality of life, as assessed using the Acne-Specific Quality of Life Questionnaire (Acne-QoL).. Mean changes from baseline to week 12 in Acne-QoL scores were analyzed in the pooled intent-to-treat population and a subgroup with treatment success (≥ 2-grade improvement on the Evaluator's Global Severity Scale and rating of "clear" or "almost clear"). Pearson correlations were conducted in the pooled intent-to-treat population to assess the relationship between the Acne-QoL acne symptoms domain and each of the other three domains.. In the pooled intent-to-treat population (n = 1640), greater mean improvements were found with tretinoin 0.05% lotion vs vehicle in all four domains: self-perception (mean change: 7.4 vs 6.7); role-emotional (6.8 vs 6.0); role-social (4.8 vs 4.6); acne symptoms (6.5 vs 5.6); all p < 0.05. Relative to the intent-to-treat population, participants who experienced treatment success with tretinoin 0.05% lotion had higher (better) mean Acne-QoL scores at week 12. Correlations between acne symptoms and the other three domains were found at baseline and week 12 (p < 0.05).. Participants with moderate-to-severe acne reported better quality of life after 12 weeks of treatment with tretinoin 0.05% lotion. Clinical improvements in acne symptoms may have contributed to these outcomes.. ClinicalTrials.gov: NCT02932306, NCT02965456.

Topics: Acne Vulgaris; Adolescent; Adult; Double-Blind Method; Drug Administration Schedule; Female; Humans; Intention to Treat Analysis; Keratolytic Agents; Male; Patient Reported Outcome Measures; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome; Tretinoin; Young Adult

Acne vulgaris (acne) is the most common dermatologic disorder seen in black patients. However, data are lacking on the effects of treatments, such as topical retinoids. Acne in black patients is frequently associated with postinflammatory hyperpigmentation (PIH), which can be of greater concern than the patient's acne and often is the main reason these patients seek a dermatologist consultation. Retinoids can treat both acne and PIH. However, the potential for retinoids to induce an irritant contact dermatitis, which could lead to PIH, is a concern. A lotion formulation of tretinoin was developed to provide an important alternative option to treat acne in black patients who may be sensitive to the irritant effects of other tretinoin formulations or where PIH is a concern.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Black People; Child; Dermatologic Agents; Double-Blind Method; Female; Follow-Up Studies; Humans; Hyperpigmentation; Male; Middle Aged; Severity of Illness Index; Skin Cream; Tretinoin; Young Adult

This phase 2, 12-week, multicenter, randomized, double-blind, active- and vehicle-controlled (VC), parallel-group trial assessed the efficacy and safety of silica encapsulated benzoyl peroxide BP (E-BP), two concentrations of silica encapsulated tretinoin (E-ATRA) and their combinations (TWIN high and low) vs VC in 726 males and females ≥9 years of age with moderate-to-severe inflammatory facial acne. The co-primary efficacy endpoints were Investigators Global Assessment (IGA) success rate ("clear" or "almost clear") and changes from baseline in inflammatory and non-inflammatory lesion counts. TWIN high and low were each significantly superior vs VC for IGA success at 12 weeks (39.7% and 27.4%, respectively, vs 12.3%,

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Time Factors; Treatment Outcome; Tretinoin

BACKGROUND: Acne is a common problem among Asian adolescents and adults. Generally, Asian skin is more pigmented, with a higher risk of acne sequelae. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns that can have significant impact on Quality of Life (QoL). The first lotion formulation of tretinoin was developed using novel polymeric emulsion technology to provide an important alternative option to treat acne patients who may be sensitive to the irritant effects of other tretinoin formulations.\ \ OBJECTIVE: To evaluate the efficacy, tolerability, and safety of tretinoin 0.05% lotion in treating moderate-to-severe acne in an Asian population.\ \ METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Asian subjects (aged 12 to 48 years, N=69 with 61% female) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear). Quality of Life (QoL) was assessed using the validated Acne QoL scale. Safety, adverse events (AEs), cutaneous tolerability and hyper- or hypo-pigmentation (using 4-point scales where 0=none and 3=severe) were evaluated.\ \ RESULTS: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 58.6% and 51.4% respectively compared with 41.5% and 23.9% with vehicle (P=0.012 for noninflammatory lesions from week 8). Treatment success was achieved by 27.2% of subjects treated with tretinoin 0.05% lotion by week 12. For each Acne QoL domain, changes from baseline achieved with tretinoin 0.05% lotion were statistically significant compared to vehicle. Only five subjects reported any AE; all AEs were mild or moderate and transient. There were no serious AEs (SAEs). There were no treatment-related AEs with tretinoin 0.05% lotion. There were slight transient increases in scaling and burning over the first 4-8 weeks. Mild hyperpigmentation was reported at baseline (mean score, 0.8) and remained mild throughout the study.\ \ CONCLUSIONS: Post hoc analysis showed that tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving reductions in noninflammatory acne lesions and improvements in QoL in an Asian population. The novel lotion formulation was well-tolerated, with no trea

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Child; Double-Blind Method; Drug Administration Schedule; Female; Humans; Keratolytic Agents; Male; Middle Aged; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome; Tretinoin; Young Adult

Background: There has been an increasing interest in gender and racial differences both in the pathogenesis and treatment of acne vulgaris (acne), and postinflammatory hyperpigmentation (PIH) is a major concern in patients of color. Female acne patients report more anxiety and depression with acne improvement positively influencing Quality of Life (QoL) than their male counterparts, and there are differences in acne presentation. The first lotion formulation of tretinoin was developed using novel polymeric emulsion technology to provide an important alternative option to treat these acne patients, especially those who may be sensitive to the irritant effects of other tretinoin formulations.\ \ Objective: To determine the impact of gender and race on the efficacy and safety of tretinoin 0.05% lotion in treating moderate or severe acne.\ \ Methods: Post hoc analysis of 2 multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate-to-severe acne. Subjects (aged 9 to 58 years, N=1640) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear). Quality of Life was assessed using the validated Acne QoL scale. Safety, adverse events (AEs), cutaneous tolerability, and hypo-/hyper-pigmentation (using a 4-point scale where 0=none and 3=severe) were evaluated at each study visit.\ \ Results: At week 12, mean percent reduction in inflammatory lesion counts were 56.9% and 53.4% respectively in female and male patients compared with 47.1% and 39.4% with vehicle (P≤0.001), with females statistically significant to males at week 8 [P=0.026]). Mean percent reduction in noninflammatory lesion counts in females and males were 51.7% and 46.1% respectively, compared with 34.9% and 29.7% with vehicle (P<0.001), with females statistically significant to males at week 12 (P=0.035). Treatment success was achieved by 23.6% and 16.1% of female and male patients treated with tretinoin 0.05% lotion by week 12 (P≤0.001 vs vehicle) with females statistically significant compared with males (P=0.013). Significant differences in inflammatory lesion count reductions were reported in Caucasian patients from week 8, and Black African/American male patients at week 12. Only male patients reported significant differences in both races

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Child; Double-Blind Method; Drug Administration Schedule; Ethnicity; Female; Gender Identity; Humans; Keratolytic Agents; Male; Middle Aged; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome; Tretinoin; United States; Young Adult

Background: A novel tretinoin 0.05% lotion formulation has been shown to be efficacious and well-tolerated, and especially effective in adult female acne patients. While it is perhaps counter-intuitive that patients with more severe disease would show clinically significant improvement with topical monotherapy, topical retinoids have been shown to offer realistic treatment options in these patients.\ \ Objective: To evaluate the safety and efficacy of once-daily tretinoin 0.05% lotion in adult females with moderate or severe acne.\ \ Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Adult females (>=18 years of age) with moderate (N=551) and severe (N=55) acne were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions, treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear) and quality of life (QoL) using the validated Acne-QoL questionnaire. Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout.\ \ Results: At week 12, efficacy in adult females with moderate acne (EGSS=3) treated with tretinoin 0.05% lotion was significantly greater than that reported with vehicle. Mean percent reduction in inflammatory and noninflammatory lesion counts was 58.5% and 55.5% respectively compared with 50.3% and 39.8% with vehicle (P=0.039 and P<0.001). Treatment success was achieved by 25.4% of subjects by week 12, compared with 15.4% with vehicle (P=0.006). Tretinoin 0.05% lotion was numerically more effective in adult females with severe acne (EGSS=4). Mean percent reduction in inflammatory and noninflammatory lesion counts was 59.0% and 58.8% respectively (compared with 53.5% and 45.5% with vehicle), and treatment success was achieved by 17.9% of subjects (compared with 4.5% with vehicle), with 46.6% of subjects achieving at least a 2-grade improvement in EGSS by week 12. Quality of life improvements with tretinoin 0.05% lotion were significant compared with vehicle in adult females with moderate acne (except role-social), but not in severe acne (probably due to the group size). The majority of AEs were mild and transient; more frequently reported in the moderate acne population where application site pain (2.9%), and application site dryness (5.0%) were the most common, compared with one report (4.5%) of applicat

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Double-Blind Method; Drug Administration Schedule; Emulsions; Facial Dermatoses; Female; Humans; Keratolytic Agents; Middle Aged; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome; Tretinoin; United States; Young Adult

BACKGROUND: While it is generally considered to be a disease of adolescence, acne affects an increasing number of adults, especially women. Although data exist on the use of retinoids in adult females, there is no universal agreement as to the age of onset of adult female acne, or data on the efficacy and tolerability dependent on age. A novel tretinoin 0.05% lotion formulation has been shown to be effective and well-tolerated in acne patients with moderate or severe disease.\ \ OBJECTIVE: To evaluate the safety and efficacy of once-daily tretinoin 0.05% lotion in women with moderate or severe acne categorized into different age groups (13-19, 20-29, and 30+ years).\ \ METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Women (aged 13-19 years, N=357; 20-29 years, N=352; 30+ years, N=156) with moderate or severe acne were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and ‘clear’/’almost clear’) and Quality of Life (QoL) using the validated Acne-QoL questionnaire. Safety and adverse events (AEs) where evaluated throughout; cutaneous tolerability assessed at each study visit using a 4-point scale (where 0=none and 3=severe).\ \ RESULTS: At baseline, 91.9% (N=794) of women in the post hoc analysis had moderate (EGSS=3) and 8.1% (N=70) severe (EGSS=4) acne, with the highest proportion of women (11.1%, N=39) having severe acne being aged 20-29 years. Baseline inflammatory lesion counts were similar across the three age ranges, with more comedonal lesions (44.5) in adolescent females (aged 13-19 years). Quality of life at baseline was much better in adolescent females and may be age-related for some domains (self-perception and role-social). At week 12, there appeared to be an age-related improvement in both inflammatory and noninflammatory lesion counts, and treatment success although the differences between groups were not significant. Mean percent reduction in inflammatory and noninflammatory lesion counts for each age group (13-19, 20-29, and 30+ years old respectively) were 55.3% (P=0.019 versus vehicle), 55.8% (P=0.080) and 63.5%; and 47.1% (P<0.001), 55.2% (P=0.002) and 59.0% (P=0.030). Treatment success for the 3 groups was achieved by 23.2% (P=0.023), 21.3%, and 30.7% of patients, re

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Age Factors; Double-Blind Method; Female; Humans; Keratolytic Agents; Quality of Life; Severity of Illness Index; Skin Cream; Surveys and Questionnaires; Treatment Outcome; Tretinoin; Young Adult

Acne vulgaris (acne) is a common skin condition in children and adolescents. Efficacy of tretinoin is well documented in studies that included pediatric patients (12-18 years of age). With acne routinely presenting in younger patients, data are needed in this important group. Lotion formulations are commonly used across dermatology and are well liked by patients.. To evaluate the safety and efficacy of a novel once-daily tretinoin 0.05% lotion in preadolescent subjects (≤ 13 years) with moderate-to-severe acne.. Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate-to-severe acne. Preadolescent subjects (N = 154) randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability evaluated throughout.. At Week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% compared with 31.4% and 18.8% with vehicle (both P = 0.001). Treatment success was achieved by 23.7% of subjects by Week 12, compared with 7.2% (P = 0.009). The majority of AEs were mild and transient: most frequently were application site pain (5.6%) and application site dryness (2.8%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by Week 12.. Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent acne. It was well tolerated, with all treatment-related AEs deemed mild or moderate.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Child; Double-Blind Method; Female; Humans; Keratolytic Agents; Male; Patient Satisfaction; Quality of Life; Severity of Illness Index; Skin; Treatment Outcome; Tretinoin

Background: Acne vulgaris (acne) is the most common dermatologic disease seen in a racially, geographically, politically, culturally, and socioeconomically diverse Hispanic population. Despite their growing demographics in the US, there are few studies evaluating acne treatment in this population. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns. The first lotion formulation of tretinoin was developed using novel polymerized emulsion technology to provide an important alternative option to treat these acne patients who may be sensitive to the irritant effects of other tretinoin formulations.\ \ Objective: To determine the efficacy and safety of tretinoin 0.05% lotion in treating moderate-to-severe acne in a Hispanic population.\ \ Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Hispanic subjects (aged 11 to 50 years, N=766) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout using a 4-point scale where 0=none and 3=severe.\ \ Results: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 60.1% and 53.0%, respectively, compared with 51.1% and 38.7% with vehicle (P≤0.001) in the Hispanic population. Treatment success was achieved by 19.6% of subjects by week 12, compared with 12.7% on vehicle (P=0.015). The majority of AEs were mild and transient. There were four serious AEs (SAEs) reported (two each group) unrelated to treatment. Incidence of treatment-related AEs with tretinoin 0.05% lotion was lower than in the overall study population; the most frequently were application site pain (2.0%), dryness (1.4%), and erythema (1.2%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate at baseline and improved by week 12. There were slight transient increases in scaling and burning over the first four weeks. Hyperpigmentation severity reduced progressively with treatment.\ \ Conclusions: Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory acne lesions i

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Child; Double-Blind Method; Drug Administration Schedule; Facial Dermatoses; Female; Hispanic or Latino; Humans; Keratolytic Agents; Male; Middle Aged; Randomized Controlled Trials as Topic; Severity of Illness Index; Skin Cream; Treatment Outcome; Tretinoin; Young Adult

Background: Acne vulgaris (acne) is a common dermatological condition typically associated with adolescents, affecting about 85% of young people. However, it is also prevalent and persistent into adulthood, particularly in females. The efficacy of tretinoin in acne is well documented with large pivotal studies. The first lotion formulation of tretinoin was developed to provide an important alternative option to treat acne patients who may be sensitive to the irritant effects of other tretinoin formulations.\ \ Objective: To determine whether efficacy and safety of tretinoin 0.05% lotion was similar in adolescent (<18 years) and adult (>=18 years) women with moderate-to-severe acne.\ \ Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Female subjects (aged 9 to 58 years, N=909) randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout.\ \ Results: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts in female subjects were 56.9% and 51.7%, respectively, compared with 47.1% and 34.9% with vehicle (P=<0.001). Similar results were seen in adult and adolescent females in terms of reduction in inflammatory lesion counts with tretinoin 0.05% lotion; reduction in noninflammatory lesions was significantly greater in adult females (P=0.002). Treatment success was achieved by 23.6% of female subjects by week 12, compared with 13.5% on vehicle (P<0.001). Although treatment success was somewhat greater in adult females (24.6% versus 21.6%), the difference was not significant. The majority of AEs were mild and transient. There were five serious AEs (SAEs) reported (4/1, adult/adolescent, respectively). The most frequently reported treatment related AEs with tretinoin 0.05% lotion were application site pain (3.0%/5.7%), and application site dryness (4.9%/6.4%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by week 12. Slight increases in mean scores were observed for scaling, burning and stinging within the first four weeks and appeared to be transient.\ \ Conclusions: Tretinoin 0.05% lotion was

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Child; Double-Blind Method; Drug Administration Schedule; Drug Compounding; Female; Humans; Keratolytic Agents; Middle Aged; Severity of Illness Index; Treatment Outcome; Tretinoin; Young Adult

Acne vulgaris is a common inflammatory skin condition which is treated using Tretinoin (TRE), a widely used retinoid. Nano emulations (NEs) are colloidal nano-sized particles that enhance the therapeutic efficacy of TRE and minimize adverse effects. This study is aimed at developing a TRE-loaded NE (NE-TRE) and at assessing the therapeutic effects of the formulation in acne vulgaris lesions, compared to conventional 0.05% TRE emulsion.. The high energy emulsification method was used to make NE-TRE. After obtaining stable NE, particle characterization and physicochemical properties were evaluated under accelerated conditions. Conducting a clinical study, we compared the therapeutic effects of NE-TRE and 0.05% TRE emulsion by comparing the number of acne lesions and porphyrin production in both sides of the face.. We successfully developed stable nanoparticles. It was a stable oil-in-water emulsion with particle size of about 150 nm, and containing circular and separated particles. In a pilot clinical study, the number of acne lesions as well as the size and intensity of porphyrin production significantly reduced after topical application of NE-TRE. This formula shows proper efficiency and good loading capacity of TRE in the drug delivery system.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Dermatologic Agents; Drug Delivery Systems; Emulsions; Female; Humans; Male; Nanoparticles; Single-Blind Method; Treatment Outcome; Tretinoin; Young Adult

Topical tretinoin has been extensively studied in clinical trials, and its essential role in the treatment of acne vulgaris (acne) established through evidence-based guidelines.. To evaluate efficacy, safety, and tolerability of a novel tretinoin 0.05% lotion in moderate-to-severe acne in patients aged 9 years and older.. A total of 1640 patients, 9-58 years of age were randomized to receive tretinoin 0.05% lotion or vehicle in two double-blind, placebo-controlled 12-week, 2-arm, parallel group studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and acne severity using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), Acne-specific quality of life (QoL) questionnaire and assessed their facial skin for shininess/oiliness improvement. The data from these two independent studies were pooled and analyzed.. Tretinoin 0.05% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (both P less than .001) at week 12 and improving acne severity (P less than .001). At week 12, mean percent change in inflammatory and noninflammatory lesions were 52% and 46%, respectively. Treatment success (a 2-grade improvement in EGSS and 'clear' or 'almost clear' was reported in 18% of patients. Tretinoin 0.05% lotion also showed significantly greater benefits relative to vehicle control in terms of patient satisfaction (P less than .001) and acne-specific QoL domains. Tretinoin 0.05% lotion was very well tolerated with no substantive differences in cutaneous tolerability among treatment groups. No patients discontinued treatment because of adverse events.. Data from controlled studies may differ from clinical practice.. Tretinoin 0.05% lotion provides statistically significant greater efficacy than vehicle with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. J Drugs Dermatol. 2018;17(10):1084-1091.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Child; Double-Blind Method; Drug Administration Schedule; Female; Humans; Keratolytic Agents; Male; Middle Aged; Quality of Life; Severity of Illness Index; Skin Cream; Surveys and Questionnaires; Treatment Outcome; Tretinoin; Young Adult

Acne, a common pediatric disease, tends to be more comedonal in preadolescents, whereas older individuals are more likely to have inflammatory lesions in addition to comedones. Thus the microbiome of preadolescents may be different. In this pilot study we aimed to characterize the preadolescent acne microbiome, compare the microbiome in preadolescents with and without acne, and investigate changes in the microbiome after topical treatment with benzoyl peroxide or a retinoid in a small cohort of preadolescents.. Participants were 7-10 years of age with (intervention group) or without (control group) acne and were recruited during routine outpatient dermatology visits. Baseline questionnaires, physical examination, and pore strip application were performed for all participants. Intervention group participants were randomized to receive topical therapy with benzoyl peroxide 5% gel or cream or tretinoin 0.025% cream. Participants with acne were followed up 8-10 weeks later and pore strip application was repeated.. Preadolescents with acne were colonized with a greater diversity of cutaneous bacteria than controls and the most commonly identified bacterium was Streptococcus. The number of bacterial species and phylogenetic diversity decreased after treatment with benzoyl peroxide and tretinoin.. The predominant bacteria in microbiome studies of adult acne is Propionibacterium, whereas in this pediatric population we saw a lot of Streptococcus bacteria. After treatment, the microbiomes of intervention group participants more closely resembled those of control group participants.

Topics: Acne Vulgaris; Administration, Topical; Benzoyl Peroxide; Child; Dermatologic Agents; Female; Humans; Keratolytic Agents; Male; Microbiota; Phylogeny; Pilot Projects; Prospective Studies; Skin; Treatment Outcome; Tretinoin

A correct therapeutic management of acne should include a maintenance therapy to prevent recurrences after discontinuing a successful treatment. The aim of this study is to investigate efficacy and safety of a 12-month maintenance treatment with a product, based on Retinsphere technology that combines retinol encapsulated in glycospheres and hydroxypinacolone retinoate (Biretix gel®), to control acne relapse after a treatment with oral isotretinoin (O.I.).. The study consisted of 2 phases: active treatment phase (AP) and maintenance phase (MP). In the AP, 40 consecutive patients with moderate facial acne were treated with O.I. until acne remission. Then, the patients entered in the MP and were treated with Biretix gel® once-daily for 12 months. The efficacy parameter was the relapse rate during MP.. Thirty-nine patients completed the study. Relapse appeared in 6 patients (15.38%). The new product with Retinsphere technology was well tolerated and none of the subjects complained of adverse events.. Our findings seems to provide favorable evidence of the efficacy and the safety of this new product in the maintenance treatment after O.I. in patient with moderate acne. The efficacy is maintain for a period as long as a year after O.I. suspension.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Butanones; Cohort Studies; Dermatologic Agents; Drug Combinations; Female; Humans; Isotretinoin; Maintenance Chemotherapy; Male; Prospective Studies; Recurrence; Treatment Outcome; Tretinoin; Vitamin A; Young Adult

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adrenal Cortex Hormones; Adult; Child; Dermatitis, Irritant; Dermatologic Agents; Double-Blind Method; Facial Dermatoses; Female; Humans; Lipids; Male; Middle Aged; Patient Satisfaction; Tretinoin; Triamcinolone; Young Adult

Olumacostat glasaretil (OG) inhibits acetyl-coenzyme A carboxylase, the enzyme responsible for the first, rate-limiting step in de novo fatty acid synthesis. OG inhibited in vitro human sebocyte lipid production and reduced in vivo sebaceous gland size in hamster ears.. Safety and efficacy of OG 7.5% gel were evaluated in patients with moderate to severe facial acne vulgaris.. Patients were randomized (1:1) to twice-daily application of OG or vehicle for 12 weeks. Efficacy was measured through changes in lesion counts and improvement in acne severity scores.. A total of 108 patients received OG (n = 53) or vehicle (n = 55); these groups had mean baseline counts of 29.7 and 28.6 inflammatory and 40.9 and 38.8 noninflammatory lesions, respectively. At week 12, OG treatment showed greater reductions from baseline in inflammatory lesions (-63.9% vs -45.9%; P = .0006) and noninflammatory lesions (-48.1% vs -28.8%; P = .0025), and more patients with greater than or equal to 2-grade improvement in investigator global assessment score (24.5% vs 7.3%; P = .0070) than vehicle. Application-site adverse events (typically mild or moderate intensity) were more common with OG.. Larger trials are needed to optimize OG dosing and confirm the current results.. OG was well tolerated and showed evidence of efficacy, suggesting further development is warranted.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Patient Selection; Prospective Studies; Reference Values; Sebum; Severity of Illness Index; Treatment Outcome; Tretinoin; Young Adult

A fixed-dose combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (VELTIN® (clindamycin phosphate and tretinoin) 1.2%/0.025% Gel [VELTIN]) (clindamycin/tretinoin gel) is currently available for the once-daily topical treatment of acne.. Two-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel.. Study 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal.. No subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation.. Clindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Aged; Anti-Bacterial Agents; Clindamycin; Dermatitis, Photoallergic; Dermatitis, Phototoxic; Drug Combinations; Erythema; Female; Humans; Keratolytic Agents; Male; Middle Aged; Treatment Outcome; Tretinoin; Young Adult

Topical tretinoin is commonly prescribed, but its frequent adverse effects are barriers to use. Predictors of resistance or susceptibility to retinoid irritation are not known.. To identify baseline patient characteristics associated with adverse effects of topical tretinoin.. This cohort study used data collected from 324 participants in the Veterans Affairs Topical Tretinoin Chemoprevention trial who were randomized to apply tretinoin cream on the face and ears. Univariate and multivariate logistic regression models were used to examine the associations between baseline characteristics and local adverse effects.. One hundred and ninety-seven patients (61% of those randomized to tretinoin) reported local adverse effects within 6 months. Clinical signs of severe photodamage at baseline [odds ratio (OR) 0·15, 95% confidence interval (CI) 0·04-0·54] and history of acne (OR 0·46, 95% CI 0·27-0·77) were associated with a decreased risk of adverse effects to tretinoin. The use of other topical medications at enrolment (OR 1·88, 95% CI 1·15-3·08) predicted an increase in adverse effects.. In this study population, the common indications of topical tretinoin treatment were associated with lower risks of adverse effects. The concurrent use of other topical medications may worsen irritation caused by tretinoin.

Topics: Acne Vulgaris; Aged; Anticarcinogenic Agents; Carcinoma; Drug Eruptions; Female; Humans; Keratinocytes; Male; Ointments; Photosensitivity Disorders; Risk Factors; Skin Neoplasms; Tretinoin

Determinants of skin irritability are poorly understood. This study aims to assess differences in cutaneous safety/irritation based on Fitzpatrick skin type among patients with acne treated with tretinoin gel microsphere (TGM). This was a phase 4, 12-week, prospective, nonrandomized, open-label, multicenter study. Approximately 500 patients with mild to moderate acne were treated with TGM 0.04% or 0.1% and assessed for cutaneous irritation at baseline and weeks 3, 6, and 12. In this post hoc analysis of patients with Fitzpatrick skin type I-III vs Fitzpatrick skin type IV-VI, there was a general trend toward initial worsening of cutaneous adverse events (AEs) by week 3 across all variables and groups. This was followed by a trend toward improvement and resolution of skin-related AEs from week 3 to week 12 regardless of Fitzpatrick skin type, with a few exceptions. Erythema was the only cutaneous AE that consistently decreased among patients with darker skin. Results from a subsequent 3-group analysis (Fitzpatrick I-II vs Fitzpatrick III-IV vs Fitzpatrick V-VI) generally mirrored those from the 2-group study. Study limitations include patient nonadherence, lack of a placebo arm, and lack of data regarding the impact of concurrent medications on outcomes. There was no correlation between irritation and Fitzpatrick skin type. ABBREVIATIONS USED: adverse event (AE), analysis of variance (ANOVA), benzoyl peroxide (BP), case report form (CRF), modified Global Acne Grading Score (mGAGS), tretinoin gel microsphere (TGM).

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Child; Dermatologic Agents; Erythema; Female; Gels; Humans; Male; Microspheres; Prospective Studies; Skin Pigmentation; Time Factors; Tretinoin; Young Adult

Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritations. Combination therapy with natural preparations could be effective in treatment and decreasing adverse events.. The aim of this study was to compare the efficacy and safety of the combination of tretinoin (TR) cream (0.05%) and Aloe vera topical gel (50%) with TR and vehicle.. The randomized, double-blind, prospective 8-week trial evaluated inflammatory and non-inflammatory lesion scores and tolerability in 60 subjects with mild to moderate acne vulgaris (global acne grading system scale).. Several formulations of A. vera leaf gel were prepared and the most stable one was selected for clinical study based on physicochemical evaluations. The combination therapy showed superior efficacy to TR and placebo. TR/Aloe vera gel (AVG) was significantly more effective in reducing non-inflammatory (p = 0.001), inflammatory (p = 0.011) and total (p = 0.003) lesion scores than control group. The highest percentage of adverse cutaneous effect was reported for scaling. At the end of study, erythema in the TR/AVG-treated group was significantly less severe (p = 0.046).. The combination TR/AVG was well tolerated and significantly more effective than TR and vehicle for the treatment of mild to moderate acne vulgaris.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Aloe; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Female; Gels; Humans; Male; Phytotherapy; Prospective Studies; Treatment Outcome; Tretinoin; Young Adult

Combination therapy using medications with complementary mechanisms of action is the standard of care in treating acne. We report results of a clinical trial evaluating the use of a fixed-dose tretinoin 0.025%/clindamycin phosphate 1.2% (T/CP) gel in combination with a benzoyl peroxide 6% foaming cloth compared with T/CP alone for facial acne. At week 12, the combination therapy group showed a trend toward greater efficacy compared with T/CP alone. There was a high success rate observed in the study, which may be attributable to the large percentage of adult female acne patients enrolled. Cutaneous adverse events were not statistically different in using combination therapy compared with T/CP alone.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Face; Female; Gels; Humans; Male; Middle Aged; Single-Blind Method; Tretinoin; Young Adult

The efficacy of topical retinoids is well known according to several clinical studies conducted predominantly among Caucasian patients. This study aimed to evaluate the efficacy and safety profile of adapalene and tretinoin among Mexican patients.. To compare adapalene 0.1 and 0.3% and tretinoin 0.05% in Mexican subjects with acne vulgaris.. We enrolled 171 patients in this single-center, randomized, double-blinded, placebo-controlled clinical trial. The patients applied on the face either adapalene 0.1%, adapalene 0.3%, tretinoin 0.05%, or placebo for 90 days and were evaluated for the reduction in total lesion counts and for the level of irritation.. Tretinoin 0.05% and adapalene 0.3% were more effective than adapalene 0.1% and placebo in the reduction of both inflammatory and noninflammatory lesions. Most of adverse events to adapalene and many on tretinoin group were related to skin irritation, dry skin, scaling, pruritus, burning, and postinflammatory hyperpigmentation.. Adapalene 0.3% and tretinoin 0.05% are comparable in efficacy, and adapalene 0.1% offers a better safety profile in Mexican patients.

Topics: Acne Vulgaris; Adapalene; Adolescent; Adult; Child; Dermatitis, Irritant; Dermatologic Agents; Double-Blind Method; Female; Gels; Humans; Hyperpigmentation; Keratolytic Agents; Male; Mexico; Naphthalenes; Pruritus; Tretinoin; Young Adult

Moderate to severe acne vulgaris is often treated with a combination of an oral antibiotic, topical antibiotic/retinoid, and benzoyl peroxide (BP), but data are limited on the efficacy of this and other combination regimens that incorporate both oral and topical therapies.
. Patients were required to be aged 12-30 years with moderate to severe acne (grades 3-4 acne on the Investigator's Global Assessment [IGA]) and deemed potential candidates for treatment with isotretinoin. Enrolled patients were given triple-combination therapy, defined in this study as oral minocycline HCl extended release 1 mg/kg QD, 6% BP foaming cloths used QD, and clindamycin phosphate 1.2%/tretinoin 0.025% gel applied QD, and were evaluated at baseline and weeks 2, 4, 8, and 12.
. A total of 97 patients were enrolled in the study. At week 12, 89% of patients had at least a one-grade improvement from baseline IGA and 96% had at least a one-grade improvement from baseline Global Aesthetic Improvement Scale score. Mean ± SD in- flammatory, non-inflammatory, and total lesion counts decreased from baseline by 61.8% ± 38.3%, 48.8% ± 34.5%, and 56.5% ± 29.9%, respectively. The percentage of patients evaluated as candidates for isotretinoin by independent photographic review was 77% (69/90) at baseline and only 16% (14/90) at week 12. Treatment-related adverse events (AEs) occurred in eight of 97 (8%) patients. Triplecombination therapy was not associated with any serious AEs or AEs leading to discontinuation.
. Triple-combination therapy was well tolerated and substantially reduced facial acne lesion counts, with 84% of patients judged to no longer be candidates for isotretinoin therapy by study end. These data support the clinical observation that a triple-combination regimen incorporating oral minocycline (dosed by patient weight), BP foaming cloths 6% QD, and clindamycin phosphate 1.2%/ tretinoin 0.025% gel QD can substantially improve moderate to severe acne vulgaris.

Topics: Acne Vulgaris; Administration, Cutaneous; Administration, Oral; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Clindamycin; Delayed-Action Preparations; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Female; Gels; Humans; Inflammation; Male; Minocycline; Severity of Illness Index; Tablets; Treatment Outcome; Tretinoin; Young Adult

The most frequent side effect of topical retinoids is irritant contact dermatitis. It occurs in approximately 85% of patients; the percentage can reach up to 95% in patients treated with tretinoin. Severity of this dermatitis is moderate to severe in approximately 20% of patients. However, 15% of patients stop the treatment with tretinoin because of skin irritation. The authors used tretinoin as short contact therapy (SCT) in mild to moderate acne, in order to try to reduce the incidence and severity of irritant contact dermatitis. They present the final results of a sponsor-free, pilot, open, multicenter study. Seventy-four patients were treated with 0.05% tretinoin cream. It was applied once daily for 30 min. Treatment duration ranged from 8 to 32 weeks (mean duration: 12 weeks). Acne severity and treatment efficacy were evaluated by means of the Global Acne Grading System. A significant clinical improvement (≥50% from baseline) was observed in 41 patients (55.4%). Thirteen patients (17.6%) developed a mild skin irritation. Four patients (5.4%) stopped the treatment because of severe skin irritation. Efficacy of tretinoin used as SCT seems to be superimposable to that of tretinoin used according to standard modality. Tolerability of SCT with tretinoin is very good. This tolerability allows a high adherence of patients to the treatment and it markedly improves compliance.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Dermatitis, Irritant; Dermatologic Agents; Female; Humans; Male; Pilot Projects; Treatment Outcome; Tretinoin; Young Adult

Topical combination therapy containing a retinoid and an antimicrobial is an effective treatment for acne vulgaris.. To evaluate the efficacy and safety of a new topical formulation containing clindamycin phosphate 1.2% and tretinoin 0.025% solubilized in an aqueous-based gel (CT gel).. 1,649 participants were randomized 2:2:2:1 to 12 weeks of double-blind treatment with CT gel, clindamycin, tretinoin, or vehicle gel administered once daily.. Significantly more participants achieved 2-grade or greater improvement on the Investigator's Static Global Assessment score with CT gel versus clindamycin, tretinoin, or vehicle gel. CT gel produced a significantly greater reduction in absolute number of total lesions versus all other treatment groups, in total and noninflammatory lesions versus clindamycin, and in total and inflammatory lesions versus tretinoin. Local tolerability was similar to that of tretinoin alone; signs and symptoms of irritation were most notable at week 2. There were no more adverse events with CT gel than with tretinoin gel.. CT gel is more effective than clindamycin or tretinoin monotherapy, with a safety and tolerability profile similar to that of tretinoin.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Anti-Bacterial Agents; Child; Clindamycin; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Follow-Up Studies; Gels; Humans; Male; Tretinoin; Young Adult

Although reliable prevalence data are not available, adult acne is thought to be somewhat common, and it is not unusual for patients to have acne as well as early signs of skin aging. A novel anti-acne/anti-aging formulation (Treatment A) has been developed for daily use by patients to address both signs of skin aging and facial acne vulgaris. The novel, non-prescription formulation includes several ingredients shown to target factors underlying the pathogenesis of acne vulgaris while also addressing multiple components in the pathophysiology of skin aging.. A blinded, randomized, split-face study was conducted to evaluate and compare the tolerability and efficacy of the novel anti-acne/ anti-aging product in subjects with photodamaged skin and acne vulgaris relative to tretinoin cream 0.025% (Treatment B). All subjects also were given supportive skincare, consisting of a cleanser, moisturizer, and sunscreen. Each treatment was assessed for its effects on subjects' appearance, lesion count reductions, and tolerability.. Treatment A produced statistically significantly greater improvements in skin tone evenness, skin tone clarity, and blemishes and blotchiness. There were also statistically greater reductions in total lesion count for acne patients on the side of the face treated with Treatment A compared to Treatment B; Treatment A was also associated with early (day 2) improvement in skin tone evenness and clarity, tactile skin smoothness, and blemishes and blotchiness. Both treatments demonstrated favorable tolerability.. The novel topical anti-aging/anti-acne therapy (Treatment A) within a comprehensive skin care regimen of cleanser, moisturizer, and sunscreen may maximize efficacy and tolerability and contribute to our armamentarium for treating both photodamage and acne at the same time.

Topics: Acne Vulgaris; Administration, Topical; Adult; Dermatologic Agents; Female; Humans; Male; Middle Aged; Pruritus; Single-Blind Method; Skin Aging; Sunscreening Agents; Treatment Outcome; Tretinoin

Acne treatment regimens have changed due to the recent over-the-counter (OTC) switch of all prescription benzoyl peroxide (BPO) topical preparations. The elimination of prescription single-agent BPO products means that dermatologists must select from a variety of OTC formulations to utilize the time-tested efficacy of BPO in the treatment of mild to moderate acne. Our research compared the efficacy and safety of an OTC BPO 5.5% formulation with lipohydroxy acid and tretinoin cream 0.025% with prescription clindamycin 1%-BPO 5% gel and tretinoin cream 0.025%. Parity was demonstrated between the 2 treatment regimens at 12 weeks.

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nonprescription Drugs; Salicylates; Treatment Outcome; Tretinoin; Young Adult

The use of topical medications for acne vulgaris is often limited by their irritant properties. Newer combination preparations are available and offer convenience, but irritant potential may still be a hindrance, perhaps more so with the combination of 2 agents. Few studies have compared these formulations directly for tolerability.. We sought to compare the tolerability of 2 combination topical acne products, clindamycin 1.2%-tretinoin 0.025% (CLIN/RA) gel and benzoyl peroxide 2.5%-adapalene 0.1% (BPO/ADA) gel.. CLIN/RA and BPO/ADA were applied daily to opposite sides of a subject's face for 21 days in a double-blinded fashion. Investigators' Global Assessments and study subject self-assessments of burning/stinging, itching, erythema, and dryness/scaling were collected. Transepidermal water loss (TEWL) was also measured as an objective measure of skin irritation. A mixed model analysis and repeated-measures analysis of variance were used to compare outcomes for both acne formulations.. CLIN/RA produced significantly less burning/stinging than BPO/ADA (P<.001) as well as significantly less pruritus than BPO/ ADA (P<.001). BPO/ADA caused significantly more TEWL than CLIN/RA (P=.005). There was no significant difference in the amount of erythema or the amount of dryness/scaling caused by either formulation.. CLIN/RA produced significantly less skin irritancy and TEWL than BPO/ADA.

Topics: Acne Vulgaris; Adapalene; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Diagnostic Self Evaluation; Double-Blind Method; Drug Combinations; Erythema; Female; Humans; Irritants; Keratolytic Agents; Linear Models; Male; Naphthalenes; Pruritus; Skin; Tretinoin; Water Loss, Insensible; Young Adult

No single effective topical treatment is available for treating all pathogenic factors causing acne vulgaris (AV). Salicylic acid (SA), tretinoin (all-TRA) and clindamycin phosphate (CDP) are known to to be effective agents depending on their comedolytic and anti-inflammatory properties.. To compare the efficacy and tolerability of SA and CDP combination (SA+CDP) with all-TRA and CDP (all-TRA+CDP) in patients with mild to moderate facial AV.. Forty-six patients aged between 18 and 35 years were enrolled in a 12-week prospective, single-blind, randomized and comparative clinical study. Efficacy was assessed by lesion counts, global improvement, quality of life index and measurement of skin barrier functions. Local side effects were also evaluated.. Both combinations were effective in reducing total lesion (TL), inflammatory lesion (IL) and non-inflammatory lesion (NIL) counts and showed significant global improvement as evaluated by the investigator. At the end of the study, there was no significant difference between the two groups in terms of all lesion counts. In addition, TL counts decreased faster in the all-TRA+CDP group compared with those in the SA+CDP group, with a significant difference between the two groups occurring as early as 2 weeks. Safety evaluations demonstrated that the incidence of mild to moderate side effects generally peaked at week 2 and declined gradually thereafter. Both combinations did not have an effect on stratum corneum hydration, although skin sebum values decreased with SA+CDP treatment.. Combination of SA+CDP and all-TRA+CDP was effective in decreasing lesion counts and well tolerated with minimal local cutaneous reactions in patients with mild to moderate AV.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Clindamycin; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Keratolytic Agents; Male; Ointments; Prospective Studies; Quality of Life; Salicylic Acid; Severity of Illness Index; Single-Blind Method; Treatment Outcome; Tretinoin; Young Adult

Post-inflammatory hyperpigmentation (PIH) is a common occurrence in patients with acne vulgaris, particularly in those with skin of colour.. A previous study has demonstrated the benefit of tretinoin (retinoic acid) in the treatment of PIH; however, there is currently no standard protocol to evaluate change in PIH following treatment. Based on these findings, we performed a pilot, exploratory, blinded, intraindividual-controlled methodology study that consisted of a photographic assessment protocol with facial mapping..   The study was based on a secondary analysis of a phase 4, community-based trial of 544 acne patients who were treated with tretinoin gel microsphere 0.04% or 0.1%. Only patients with Fitzpatrick types III-V (skin of colour) were included in the study; subjects with Fitzpatrick skin type VI were excluded because the photographic assessment did not allow for proper evaluation.. Despite the small number of subjects evaluated (n=25), the results revealed consistent assessment of improvement in PIH between two independent graders (weighted κ=0.84).. Further study with a larger population is recommended to validate the accuracy of this method.

Topics: Acne Vulgaris; Dermatitis; Dermatologic Agents; Humans; Photography; Pigmentation Disorders; Pilot Projects; Tretinoin

Acne vulgaris is a disorder of the pilosebaceous unit in which the androgens contribute to its onset and persistence. The use of antiandrogens is therefore potentially effective; however, antiandrogens for topical use are not available on the market. Cortexolone 17α-propionate (CB-03-01; Cosmo S.p.A, Lainate, Italy) is a new potent topical antiandrogen potentially useful in acne vulgaris.. To evaluate the safety and the topical efficacy of CB-03-01 1% cream in acne vulgaris as compared with placebo and with tretinoin 0·05% cream (Retin-A® ; Janssen-Cilag).. Seventy-seven men with facial acne scored 2-3 according to Investigator's Global Assessment (IGA) were randomized to receive placebo cream (n = 15), or CB-03-01 1% cream (n = 30), or tretinoin 0·05% cream (n = 32) once a day at bedtime for 8 weeks. Clinical efficacy was evaluated every 2 weeks including total lesion count (TLC), inflammatory lesion count (ILC), acne severity index (ASI) and IGA. Safety assessment included local irritancy score, laboratory tests, physical examination, vital signs and recording of adverse events.. CB-03-01 1% cream was very well tolerated, and was significantly better than placebo regarding TLC (P = 0·0017), ILC (P = 0·0134) and ASI (P = 0·0090), and also clinically more effective than comparator. The product also induced a faster attainment of 50% improvement in all the above parameters.. This pilot study supports the rationale for the use of topical antiandrogens in the treatment of acne vulgaris. CB-03-01 1% cream seems to fit with the profile of an ideal antiandrogen for topical use.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Androgen Antagonists; Anti-Inflammatory Agents; Cortodoxone; Double-Blind Method; Emollients; Humans; Keratolytic Agents; Male; Middle Aged; Pilot Projects; Propionates; Severity of Illness Index; Tretinoin; Young Adult

Acne vulgaris is common in young adolescents. Retinoids are widely used but may be associated with poor tolerability. This post hoc analysis of 483 participants aged 10 to 14 years with mild to moderate acne compared efficacy and tolerability of once-daily treatment with micronized tretinoin gel 0.05%, tretinoin gel microsphere 0.1%, and vehicle over 12 weeks. In study 1, inflammatory and noninflammatory lesion reduction and treatment success was comparable between tretinoin gel 0.05% and tretinoin gel microsphere 0.1%. Inflammatory (46.3%) and noninflammatory (45.7%) lesion reductions with tretinoin gel 0.05% were significantly greater than vehicle (37.1% and 27.9%, respectively) (both P<.001). In study 2, inflammatory and noninflammatory lesion reductions and treatment success with tretinoin gel 0.05% (30.6%, 39.1%, and 19%, respectively) were significantly greater than vehicle (10.9%, 16.9% [both P<.001], and 4% [P=.008], respectively). Tretinoin gel 0.05% was significantly better tolerated than tretinoin gel microsphere 0.1% (P<.001); the majority of adverse events (AEs) were mild, occurring in the first 2 weeks. Fourteen percent of participants reported dry skin, 8% skin burning sensation, 5% erythema, and 5% dermatitis exfoliative with tretinoin gel 0.05% compared with 32%, 11%, 23%, and 23%, respectively, with tretinoin gel microsphere 0.1% (all P<.001, except skin burning sensation). In this secondary analysis of acne in young adolescents aged 10 to 14 years, micronized tretinoin gel 0.05% provided a comparable lesion reduction and treatment success versus tretinoin gel microsphere 0.1%, with a better cutaneous tolerability profile.

Topics: Acne Vulgaris; Adolescent; Child; Double-Blind Method; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Treatment Outcome; Tretinoin

Combination products in which the individual components have different mechanisms of antimicrobial action have been shown in many disease states to provide the most effective therapy.. This 16-week, two-center, investigator-blinded, randomized, parallel-group study evaluated the antimicrobial efficacy of clindamycin phosphate 1%/benzoyl peroxide 5% gel (BPO/C) as compared to a clindamycin phosphate 1.2%/tretinoin 0.025% gel (T/C) over 16 weeks in the treatment of moderate to moderately severe acne.. While subjects in both arms experienced reductions in total Propionibacterium acnes (P. acnes) counts, the BPO/C arm produced greater reductions throughout the study. Furthermore, overall reductions in the number of clindamycin-resistant and erythromycin-resistant P. acnes occurred only in BPO/C treated subjects.. These data suggest that clindamycin phosphate 1%/benzoyl peroxide 5% gel reduces P. acnes counts and mitigates the emergence of antimicrobial resistance.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Clindamycin; Drug Combinations; Female; Gels; Humans; Male; Single-Blind Method; Tretinoin

Topical tretinoin and benzoyl peroxide (BPO) are often prescribed in combination for the treatment of acne vulgaris; however, these products have not traditionally been administered simultaneously because of the potential for tretinoin degradation by BPO as well as the instability of tretinoin in daylight. The primary objective of this randomized, investigator-blinded, 12-week, phase 4 trial was to determine non-inferiority of a once-daily morning combination regimen of 5% BPO wash + tretinoin gel microsphere (TGM) 0.04% pump versus a sequential regimen (BPO in the morning/TGM in the evening) in patients > or = 12 years old with moderate facial acne vulgaris. The primary efficacy endpoint was the change from baseline in total acne lesions; the primary safety endpoint was the change in cutaneous irritation scores. The 247 participants (mean age: 18.5 years) were randomized to either the morning/morning regimen (n = 123) or the morning/evening regimen (n = 124). The morning/morning regimen was determined to be non-inferior to the morning/evening regimen in reduction of total acne lesions. The tolerability of both regimens was comparable. The morning/morning regimen is a safe and effective treatment option for patients with moderate acne vulgaris.

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Child; Drug Administration Schedule; Drug Therapy, Combination; Female; Gels; Humans; Male; Tretinoin

This single-center, investigator-blinded, randomized, split-face, phase 4 study compared the irritation potential of tretinoin gel microsphere (TGM) 0.04% in a pump dispenser with adapalene 0.1% plus benzoyl peroxide 2.5% gel (ADA-BPO 0.1%/2.5%) in a panel of 170 subjects. Participants were treated with TGM 0.04% pump on a randomly assigned side of the face and ADA-BPO 0.1%/2.5% gel on the other side of the face daily for three consecutive weeks. Expert grader assessments of erythema and dryness and subject self-assessments of burning/stinging and itching were conducted daily, except on weekends. TGM 0.04% pump was associated with better facial tolerance as demonstrated by significantly less cumulative erythema (P < 0.0001), dryness (P < 0.0001), burning/stinging (P < 0.0001) and itching (P < 0.0001) compared with ADA-BPO 0.1%/2.5% gel. While both agents were well tolerated by most patients, TGM 0.04% pump demonstrated significantly better tolerance than ADA-BPO 0.1%/2.5% gel in both neurosensory parameters and signs of contact irritation.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Adolescent; Adult; Benzoyl Peroxide; Dermatologic Agents; Drug Combinations; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Naphthalenes; Pilot Projects; Single-Blind Method; Treatment Outcome; Tretinoin; Young Adult

New combination topical formulations for the treatment of acne may improve outcomes by increasing adherence. We assessed adherence to and efficacy of a combination topical medication for acne applied once daily compared with daily applications of 2 separate generic subcomponents. Twenty-six participants with mild to moderate acne vulgaris were randomized to 12 weeks of once daily application of clindamycin phosphate 7.2%-tretinoin 0.025% gel (CTG) combination product or separate daily applications of clindamycin phosphate gel 1% and tretinoin cream 0.025% (C gel + T cream) for a total of 2 applications daily. Disease severity was measured at baseline and weeks 4, 8, and 12. Adherence was monitored using electronic monitoring caps on the medication tubes. Of the 26 participants enrolled, 21 completed the 12-week study. Median adherence in the CTG group was 88% compared with 61% in the C gel + T cream group. There was a 51% mean reduction in total lesions for the CTG group versus a 32% mean reduction for the C gel + T cream group by the end of the study. Both CTG and separate applications of C gel + T cream improved mild to moderate acne. The use of a once daily combination product has the advantage of promoting better adherence and clinical outcomes.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Anti-Bacterial Agents; Child; Clindamycin; Drug Therapy, Combination; Female; Gels; Humans; Male; Patient Compliance; Severity of Illness Index; Statistics, Nonparametric; Treatment Outcome; Tretinoin

The multiple etiologic factors involved in acne vulgaris make the use of several medications necessary to treat the condition. Use of a fixed combination of clindamycin phosphate 1.2% and tretinoin 0.025% in conjunction with a benzoyl peroxide (BPO) wash 4% targets several pathologic factors simultaneously and mitigates the potential for clindamycin-induced Propionibacterium acnes-resistant strains. New formulations may allow such regimens to be effectively used without overly reduced tolerability resulting from the irritation potential of tretinoin and BPO. This randomized, single-blind study investigated the local tolerability, irritation potential, and safety of an aqueous-based gel (clindamycin phosphate 7.2%-tretinoin 0.025% [CT gel]) when used in conjunction with a BPO wash 4% in participants with mild to moderate acne vulgaris. Participants applied the CT gel once daily in the evening for 4 weeks in conjunction with once-daily morning use of either BPO wash 4% or nonmedicated soap-free cleanser lotion (SFC). Local tolerability and irritation potential were assessed by participants and investigators using separate 6-point scales. The frequency and severity of dryness, scaling, erythema, burning/stinging, and itching increased during the first week of treatment in both treatment arms but decreased thereafter. Local tolerability reactions were slightly more frequent in the CT gel + BPO wash group versus the CT gel + SFC group at week 1 but were generally mild and improved within 1 to 2 weeks. In conclusion, therapy with CT gel + BPO wash appears safe and well-tolerated in participants with mild to moderate acne vulgaris.

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Clindamycin; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Female; Gels; Humans; Keratolytic Agents; Male; Severity of Illness Index; Single-Blind Method; Tretinoin; Young Adult

Newer agents and formulations seek to improve the tolerability of topical retinoid therapy. Recently, a gel containing crystalline clindamycin 1.2% and tretinoin 0.025% (CLIN/RA) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of treating mild-to-moderate acne.. This single-center, randomized, evaluator-blind phase 1 study compared the tolerability of CLIN/RA to 0.1% tretinoin gel or 0.1% adapalene gel.. Forty-five patients applied CLIN/RA once daily to one side of their face every day for 21 days. Patients were randomized to either tretinoin 0.1% (n = 23) or adapalene 0.1% (n = 22) on the contralateral side. A clinical evaluator assessed degree of erythema and scaling; patients provided subjective evaluations of burning, stinging, and itching.. CLIN/RA was significantly better tolerated than was 0.1% tretinoin gel, as evidenced by significantly reduced erythema (P < 0.04), scaling (P < 0.03), itching (P < 0.02), burning (P < 0.03) and stinging (P < 0.04). A trend for greater erythema, scaling, and subjective discomfort for 0.1% adapalene gel compared to CLIN/RA was also evident.

Topics: Acne Vulgaris; Adapalene; Adolescent; Adult; Anti-Bacterial Agents; Clindamycin; Dermatologic Agents; Drug Combinations; Female; Gels; Humans; Male; Microspheres; Naphthalenes; Tretinoin; Young Adult

Combination therapy has become the standard for the management of acne, particularly for moderate-to-severe cases. Among these combinations, those regimens containing benzoyl peroxide (BPO), clindamycin and a retinoid have been used frequently as they address most aspects of acne pathogenesis. This study compares the efficacy and safety of two common topical treatment regimens in the treatment of a moderate to severe facial acne vulgaris: fixed-combination gel containing BPO 5% and clindamycin 1% (BPO/C) plus tretinoin microsphere gel 0.04% (RAM) versus a regimen of a fixed-combination gel containing clindamycin phosphate 1.2% and tretinoin 0.025% (CPT) plus a once-daily BPO 5% wash. While both regimens were safe and effective, regimen BPO/C+RAM yielded a more rapid onset of effect versus regimen CPT+BPO against both non-inflammatory and inflammatory lesions. Both treatment regimens were well-tolerated.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Clindamycin; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Female; Gels; Humans; Keratolytic Agents; Male; Propionibacterium acnes; Prospective Studies; Severity of Illness Index; Single-Blind Method; Treatment Outcome; Tretinoin; Young Adult

This 12-week, single-center, investigator-blinded, randomized, parallel-design study assessed the safety and efficacy of tretinoin microsphere gel 0.04% delivered by pump (TMG PUMP) to tazarotene cream 0.05% (TAZ) in mild-to-moderate facial acne vulgaris. Efficacy measurements included investigator global assessment (IGA), lesion counts, and subject self-assessment of acne signs and symptoms. Efficacy was generally comparable between treatment groups, although TMG PUMP provided more rapid results in several parameters. IGA showed a more rapid mean change from baseline at week 4 in the TMG PUMP group (-0.18 versus -0.05 in the TAZ subjects). TMG PUMP yielded more rapid improvement in papules. At week 4, the mean percentage change from baseline in open comedones was statistically significant at -64% in the TMG PUMP group (P=0.0039, within group) versus -19% in the TAZ group (not statistically significant within the group; P=0.1875). Skin dryness, peeling and pruritus were significantly less in the TMG PUMP group as early as week 4. Adverse events related to study treatment were rare in both groups and all resolved upon discontinuation of study medication.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Child; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Nicotinic Acids; Pilot Projects; Severity of Illness Index; Single-Blind Method; Treatment Outcome; Tretinoin; Young Adult

A randomised study was carried out to evaluate the efficacy of four topical medications individually and in combination to treat grade I acne vulgaris which is characterised by mild lesions (< 10 in one side of face) consisting of predominantly comedones with occasional pustules in oily skin. Maintaining the inclusion and exclusion criteria 100 patients were selected and divided into 5 groups to receive different topical drugs at random basis in the dermatology OPD. Topical medication given to them is mentioned below against each group: Group I--retinonic acid, group II--benzoyl peroxide, group III--clindamycin, group IV--cleanser and group V--all the four medications. The patients were observed for reduction in number of comedones, suppression of papulopustules with healing rate, effects on facial skin, and rate of recurrence. Results were observed according to the groups. In group I old acne was reduced in size and gradually cleared off (80%). Recurrence was few with appearance of new microcomedones which were cleared off within short time. Skin became smoother and fresh. Texture became lighter in colour. In group II whiteheads were reduced at about 70% in number. Rate of recurrence was normal. Skin became rough and dry. In group III pustular acne healed better and faster. In group IV acne of oily skin healed better and faster. Rate of recurrence was normal. Skin became fresh and oil-free. In group V reduction of lesions was very much significant (90%) with quick healing rate of the comedones. Recurrence was normal but delayed. Skin became smoother, finer and fresher. So, combination therapy is better. Cleanser is always helpful even without medications.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Detergents; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Severity of Illness Index; Treatment Outcome; Tretinoin; Young Adult

Patient satisfaction and quality of life are important considerations when assessing products used to treat acne vulgaris, as these factors may affect treatment adherence and subsequent treatment outcomes. The objective of this analysis was to determine patient satisfaction and improvement in quality of life after treatment with tretinoin gel microsphere (TGM) in a pump dispenser. Assessments were made during a phase IV, prospective, 12-week, open-label, community-based trial in which 544 patients who were dissatisfied with their current acne treatments received TGM 0.04% or 0.1% in addition to < or = 2 concurrent non-retinoid acne therapies. At week 12, significant improvement was reported in both patient acne therapy satisfaction and in the overall mean Acne Quality of Life Index scale (P < 0.0001 versus baseline for both measures). The majority of patients (82.3%) rated the pump dispenser as an "excellent" or "very good" means of dispensing medication, and 86.0% rated their overall satisfaction with the pump treatment application as "very satisfied" or "extremely satisfied." The results of this study indicate that the use of TGM in a pump dispenser in patients with acne vulgaris is associated with significant increases in both quality of life and patient satisfaction.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Female; Humans; Male; Medication Adherence; Microspheres; Middle Aged; Patient Satisfaction; Prospective Studies; Quality of Life; Tretinoin

Concern exists about using topical retinoids on patients with inflammatory acne lesions, fearing that a flare in inflammation will occur. In 3 multicenter, double-blind, randomized, phase 3 trials of a clindamycin phosphate 1.2%-tretinoin 0.025% gel (CLIN/RA), clinical evaluations after 2 weeks of treatment determined if flaring occurred in participants treated with tretinoin gel 0.025% (RA) monotherapy, and the difference in inflammation when treated with the combination formulation. Flaring was assessed as an increase in inflammatory lesions of 10% or greater or 20% or greater versus baseline. Most participants experienced improvement in lesions across treatment groups. Participants with mild acne at baseline treated with RA monotherapy had significantly higher rates of flaring compared with participants treated with vehicle gel (VEH) (P < .001). Treatment with CLIN/RA or clindamycin phosphate gel 1.2% (CLIN) monotherapy resulted in significantly lower rates of flaring than RA or VEH (P < .001 for all). Participants with moderate to severe acne showed no signs of RA-induced flaring. In each comparison, the CLIN/RA combination showed the lowest percentage of increased inflammatory lesions. These results indicate that RA-induced flaring may occur with mild inflammation; combining RA with CLIN prevents this flaring. Participants with moderate to severe inflammatory acne did not show an increase in inflammatory lesions compared with participants treated with VEH. Lack of flaring may result from either the novel vehicle formulation or the antiinflammatory effects of CLIN.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Clindamycin; Double-Blind Method; Drug Combinations; Female; Gels; Humans; Male; Middle Aged; Treatment Outcome; Tretinoin

Acne affects as many as 50 million individuals in the United States. Topical therapy combining a retinoid and an antibiotic is recommended as a first-line therapeutic option for mild to moderately severe acne. Although treatment for extended durations may be required, little long-term safety data on these combination therapies are available. This report summarizes the long-term safety and tolerability of a novel combination product for the treatment of acne vulgaris in participants 12 years and older. The combination treatment is a gel formulation containing a crystalline suspension of clindamycin phosphate 1.2%-tretinoin 0.025% (CLIN/RA). Two cohorts participated in a long-term (up to 52 weeks), multicenter, open-label, safety evaluation of CLIN/RA. Treatment duration was 6 months for the first cohort (N = 442) and 12 months for the second cohort (N = 213). Overall, the CLIN/RA gel was well-tolerated; 92%, 91%, and 94% of participants reported no itching, burning, or stinging, respectively. The most frequent adverse events were acne (29/442; 7% [usually a flare]), sunburn (12/442; 3%), hypersensitivity (7/442; 2%), contact dermatitis (5/442; 1%), and application-site desquamation (3/442; 1%). These results confirm the safety of CLIN/RA gel for mild to moderately severe acne. The CLIN/RA gel fixed-dose combination provided minimal adverse events and a favorable safety profile for 2 agents with established efficacy for the treatment of acne vulgaris.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Clindamycin; Cohort Studies; Drug Combinations; Female; Follow-Up Studies; Gels; Humans; Male; Middle Aged; Severity of Illness Index; Time Factors; Treatment Outcome; Tretinoin; United States; Young Adult

It is well known that the setting of clinical trials for registration studies do not necessarily represent efficacy seen in clinical practice, where physicians have the flexibility to select, combine, and change the acne treatment prescription. In this phase 4, open-label, multicenter, community-based study, 544 patients who were dissatisfied with their current acne treatment received tretinoin gel microsphere (TGM) 0.04% or 0.1% in a pump dispenser for 12 weeks. Patients were allowed the use of up to 2 other concurrent acne therapies, not including other retinoids. A total of 361 patients received TGM 0.04% and 183 received TGM 0.1%. Compliance was high (defined as 75% to 100% of prescribed doses taken) for approximately 95% of patients in both groups at every evaluation. At week 12, the mean modified Global Acne Grade score (mGAGs) and the investigator global evaluation (IGE) demonstrated significant (P<.0001) improvement from baseline for both concentrations, with 72% having at least moderate improvement. In approximately 25% of patients, acne was assessed as cleared or almost cleared. Most side effects were characteristic of topical retinoids. These results indicate TGM in a pump dispenser as an effective, well-tolerated acne treatment that is associated with a high rate of compliance.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Dose-Response Relationship, Drug; Face; Female; Gels; Humans; Keratolytic Agents; Male; Medication Adherence; Microspheres; Middle Aged; Severity of Illness Index; Treatment Outcome; Tretinoin; Young Adult

Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritation, including erythema, peeling, dryness, burning, and itching. Tretinoin gel microsphere (TGM) formulations were developed to minimize these effects. A lower-strength TGM formulation may be desirable to further reduce exposure to tretinoin.. This study was conducted to assess the efficacy and safety profile of a lower-dose TGM (0.04%) formulation compared with TGM 0.1% for the treatment of mild to moderate acne vulgaris.. In this multicenter, double-blind, parallel-group, Phase IV dose-ranging study, patients with facial acne were randomized to apply either TGM 0.04% or TGM 0.1% to the face each night for 12 weeks. Patients must have discontinued systemic retinoid treatment for at least 1 year before the study and were not to have used any topical retinoids, systemic antibiotics, nicotinamide, or systemic steroids for at least 1 month. All other topical medications applied to the face (including corticosteroids, antimicrobials, salicylic acid, and benzoyl peroxide) were to be discontinued at least 2 weeks before the study. End points were the acne lesion count (total, inflammatory, and noninflammatory lesions) and the investigators' and patients' assessments of improvement. Adverse events (including severity and relationship to treatment) and signs and symptoms of cutaneous irritation at the treatment site were monitored at each study visit.. One hundred fifty-six patients (78 TGM 0.04%, 78 TGM 0.1%) were randomized and received treatment. Patients ranged in age from 12 to 41 years (mean, 18.4 years) and were predominantly white (n = 89 [57.1%]) and male (n = 80 [51.3%]). Both TGM 0.04% and TGM 0.1% were associated with a reduction from baseline in total, inflammatory, and noninflammatory lesions. The differences between groups in the change in lesion counts from baseline to weeks 2, 4, 8, and 12 were not statistically significant. However, there was a greater reduction in inflammatory lesions at week 2 for TGM 0.1% compared with TGM 0.04% (14.8% vs 6.0%, respectively; P < 0.047). Both treatment groups had similar improvements in the investigators' global evaluation and the patients' assessment of the response to treatment. Both TGM 0.04% and TGM 0.1% were well tolerated. The most common adverse events were skin-associated burning sensation (2.6% in the TGM 0.04% group and 7.7% in the TGM 0.1% group) and irritation (6.4% and 3.8%, respectively). In the TGM 0.04% group, significantly fewer patients experienced dryness of the treatment area during the early phase of treatment (P < 0.027). However, for other measures of cutaneous irritation (peeling, burning/stinging, and itching), either there were no statistically significant differences between treatment groups or, in the case of erythema, there was a significant difference in favor of TGM 0.1% (P = 0.035).. Both TGM 0.04% and TGM 0.1% were associated with reductions in lesion counts in these patients with mild to moderate facial acne. Both concentrations were generally well tolerated. The results suggested an early (week 2) incremental benefit for the use of TGM 0.1% in the treatment of inflammatory lesions.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Dose-Response Relationship, Drug; Double-Blind Method; Face; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Severity of Illness Index; Skin; Time Factors; Treatment Outcome; Tretinoin

Acne is characterized by different types of lesions at different stages of development. Therefore, combination therapy may offer numerous advantages, including enhanced efficacy and better tolerability. The addition of benzoyl peroxide (BPO) to all long-term antibiotic treatment is widely advocated to help suppress the emergence of antibiotic-resistant bacteria. Topical retinoids are recommended as early initiation treatment of most patients with acne because they target most mechanisms of acne pathogenesis. In the clinical setting, therapeutic regimens that include retinoids and topical antibiotic-BPO combination formulations frequently are prescribed. This study investigated the efficacy and safety of combination therapy with clindamycin 1%-BPO 5% topical gel plus tretinoin microsphere (RAM) gel 0.04% or 0.1% or adapalene (AP) gel 0.1% in moderate to severe acne.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Administration, Topical; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Female; Gels; Humans; Male; Microspheres; Naphthalenes; Propionibacterium acnes; Severity of Illness Index; Treatment Outcome; Tretinoin

This double-blinded, randomized, vehicle-controlled, multicenter, parallel-group, 12-week, phase 4 study was conducted in adults with mild to moderate acne vulgaris. Of 178 subjects randomized to be treated, 88 subjects (49%) were treated with tretinoin gel microsphere 0.04% and 90 subjects (51%) were treated with vehicle. Inflammatory lesion counts were statistically significantly reduced at 2 weeks in tretinoin-treated subjects (P = .0110), and reductions in total lesion counts also were noted. The reduction in total lesion counts reached statistical significance at week 4 (P = .0305); at week 12, mean total, inflammatory, and noninflammatory lesion counts were statistically significantly lower in the tretinoin treatment group versus vehicle group (P < .05), and mean percentage reductions in lesion counts were significantly greater in the subjects with noninflammatory lesions treated with tretinoin compared with vehicle (P < .05). Mean percentage reductions in total, inflammatory, and noninflammatory lesion counts were 35.5%, 38.2%, and 33.6%, respectively, at week 12 for the tretinoin treatment group compared with 20.9%, 19.2%, and 20.4%, respectively, for the vehicle group (all P < .05). All adverse events were of mild or moderate intensity with the exception of severe skin irritation in one tretinoin-treated subject. At week 12, there were no statistically significant differences between treatment groups for any measured tolerability parameter.

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Double-Blind Method; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Middle Aged; Treatment Outcome; Tretinoin

Topical retinoids are the cornerstone of therapy for acne vulgaris. Nevertheless, the adjunctive use of other anti-acne agents can help enhance the efficacy of topical retinoids still further. Given that tazarotene 0.1 percent gel has previously shown significantly greater efficacy than tretinoin 0.025 percent gel, it is likely that tazarotene plus clindamycin offers superior efficacy to tretinoin plus clindamycin, which has recently become available as a combination product. A total of 150 patients with facial acne vulgaris were randomly assigned to receive either tazarotene 0.1 percent cream plus clindamycin 1 percent gel, or tretinoin 0.025 percent gel plus clindamycin 1 percent gel. Each medication was applied once daily in the evening (clindamycin followed by the retinoid 5-10 minutes later) for up to 12 weeks. At week 12, the reduction from baseline in lesion counts was greater with tazarotene/clindamycin than tretinoin/clindamycin for both the non-inflammatory lesion count (71% vs. 52%, p< or =.01) and the inflammatory lesion count (77% vs. 67%, P=.053). Tazarotene/clindamycin also resulted in a significantly higher incidence of patients achieving > or = 50 percent global improvement (incidence of 88% vs. 75% at week 12; p< or =.05). Both regimens were similarly well tolerated. In the treatment of facial acne vulgaris, tazarotene plus clindamycin offers significantly greater efficacy than tretinoin plus clindamycin and has comparable tolerability.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Anti-Bacterial Agents; Child; Clindamycin; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Gels; Humans; Keratolytic Agents; Male; Middle Aged; Nicotinic Acids; Ointments; Retinoids; Severity of Illness Index; Treatment Outcome; Tretinoin

The development of a hydrogel to stabilize and solubilize clindamycin and tretinoin provides a single, once-daily treatment for acne vulgaris.. Our aim was to compare the efficacy and safety of the combination of clindamycin (1%) and tretinoin (0.025%) with each agent alone and vehicle.. Two randomized, double-blind, active drug- and vehicle-controlled 12-week studies evaluated inflammatory and noninflammatory lesion counts and the Investigator's Static Global Assessment in 2219 subjects with acne vulgaris.. The combination demonstrated superior efficacy to clindamycin, tretinoin, and vehicle. Combination hydrogel was significantly more effective in reducing inflammatory (P < .005), noninflammatory (P < or = .0004), and total (P < .0001) lesion counts than the other treatments and vehicle. The proportion of subjects with clear or almost clear skin on the Investigator's Static Global Assessment was greater with the combination (P < .0001).. A majority of subjects (82.6%) had grade 2-3 acne vulgaris at baseline; therefore these overall results may not be representative of the response in the subjects (17.4%) with grade 4-5 acne.. The combination clindamycin/tretinoin hydrogel was well tolerated and significantly more effective than clindamycin, tretinoin, or vehicle for the treatment of acne vulgaris.

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Clindamycin; Dermatitis; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrogel, Polyethylene Glycol Dimethacrylate; Male; Severity of Illness Index; Treatment Outcome; Tretinoin

Retinoic acid (RA) has long been used, both topically and systemically, for disorders of keratinization, acne and related disorders. In the present study, the efficacy and tolerability of topical RA prepared as a cyclodextrin beta complex (beta-CD) is investigated in 66 acne vulgaris patients.. This randomized, double-blind, placebo-controlled study compares nightly topical application of RA/beta-CD complex hydrogel formulation (0.025%), RA/beta-CD complex in moisturizing base (0.025%), hydrogel base, moisturizer base or a commercial RA gel (0.05%) in acne vulgaris patients. Improvement of acne was assessed using a 5-point improvement scale and by measuring sebum and moisture content of the skin using an SM 810 sebumeter/corneometer.. After 3 months of treatment, mean scores of acne improvement on the 5-point scale were 4 with the RA/beta-CD complex hydrogel formulation, 4.1 with the RA/beta-CD complex in moisturizing base, 1.2 with hydrogel placebo base, 1.1 with moisturizer placebo base and 3 with the commercial RA product. All patients treated with the commercial product experienced local side-effects. One patient discontinued due to severe irritation. None of the patients treated with the RA/beta-CD complex in the moisturizing base and hydrogel formulation experienced significant local irritation, although the sebum content of the skin decreased after application of the RA/beta-CD preparations. This change was not significant compared to controls. The moisture content of the skin was better preserved in the group treated with the RA/beta-CD complex in the moisturizing base.. The topical RA/beta-CD complex, in hydrogel and moisturizing base, was more effective than the twice concentrated commercial RA product. There were few topical side-effects with this new formulation, which increases patient compliance. Topical RA/beta-CD (0.025% RA) did not significantly reduce sebum secretion but may help to preserve optimum epidermal moisture content with the proper base formulation. This is the first study in the literature reporting efficacy and tolerability of the topical RA/beta-CD complex in acne vulgaris. We conclude that the topical RA/beta-CD complex displays an improved efficacy and tolerability profile and is an effective treatment alternative for acne vulgaris.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Cyclodextrins; Double-Blind Method; Drug Combinations; Female; Gels; Humans; Hydrogels; Keratolytic Agents; Male; Tretinoin

To observe the clinical curative effect of Chinese medicine "xiao cuo fang" combined with adapalene gel in the treatment of acne vulgaris.. 133 patients with acne vulgaris were divided into treatment group (80 cases) and control group (53 cases) randomly. The treatment group topically applied "xiao cuo fang" combined with 0.1% adapalene gel, the control group topically applied 0.03% retinoic acid cream. After 8 weeks, we observed the reductive percentage of skin injury, the effective rate of the treatment and the incidence rate of adverse reactions.. The average of overall skin injury, the average of inflammatory and of non-inflammatory in the treatment group reduced 82.7%, 81.0%, 84.3%, respectively, and the control group reduced 60.5%, 59.1%, 61.9%. The difference between them had obvious significance (P < 0.05). The effect rate of the treatment group was 85.0%, and the control group was 69.8%. The difference between them had obvious significance (P < 0.05). The incidence rate of adverse reaction of the treatment group was 27.5%, and the control group was 45.3%. The difference between them had obvious significance (P <0.05).. The curative effect of "xiao cuo fang" combined with adapalene gel in the treatment of acne vulgaris is precise, and the side effects are small.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adult; Drug Therapy, Combination; Drugs, Chinese Herbal; Female; Gels; Humans; Male; Naphthalenes; Phytotherapy; Tretinoin

Isotretinoin is well known in the therapy of acne papulopustulosa and acne conglobata. No study has investigated the pathophysiological changes of the skin of acne patients, especially when low dose oral isotretinoin is given in combination with topical tretinoin.. 28 patients were treated for 6 months with oral isotretinoin. In the acne conglobata group (A-C) patients were treated with 10 mg (Group A) or 20 mg isotretinoin (Groups B, C) in combination with topical 0.05% tretinoin cream. Group C was treated the first 2 weeks with 0.05% betamethasone valerate cream instead of tretinoin cream. In the acne papulopustulosa group, the patients received 0.5 mg isotretinoin/kg bodyweight and 0.05% tretinoin cream, either alone (Group E), or with oral methylprednisolone during induction (Group D).. Acne conglobata--A reduction of inflammatory lesion by 87-94% and of non-inflammatory lesions by 81-88% was achieved (Groups A-C). A reduction of sebaceous gland size by 35-58%, sebum production by 90-95%, follicular keratinization by 55-70% and Propionibacteria by 33-73% was seen (Groups B and C better than Group A). In Group A the amount of lipids was only reduced by 6%, in Group B by 35% and in Group C by 40%. Acne papulopustulosa--Sebum excretion rate and follicular keratinization were reduced in Group D by 89% and 50% respectively, with isotretinoin alone by 94% and 53%. The amount of lipids was reduced in Group D by 40% and in Group E by 21%.. Because of the efficacy and cost-benefit relationship of isotretinoin in the treatment of acne compared to other therapeutic approaches, further use low dose isotretinoin in the described settings seems to justified.

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Adolescent; Adult; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Female; Humans; Isotretinoin; Male; Severity of Illness Index; Skin; Treatment Outcome; Tretinoin

Our purpose was to evaluate the efficacy and safety of a combination of benzoyl peroxide 6% cleanser and tretinoin 0.1% microsphere gel versus monotherapy with tretinoin 0.1% microsphere gel. Eighty-seven healthy males and nonpregnant nonlactating females between the ages of 12 and 30 years with moderate inflammatory acne vulgaris were enrolled in this randomized controlled, investigator-blind, parallel group clinical trial. Subjects were evaluated over 12 weeks for a total of 4 visits. The investigators and subjects completed questionnaires about the test medications. Data from the 56 subjects completing the protocol were considered in the analyses of efficacy and tolerability. The reduction in inflammatory lesions from baseline was significant for both treatment groups at the end of the study. However, there was a significantly greater reduction in the group receiving the combination regimen. Both treatment groups had significant reductions from baseline in noninflammatory lesions at week 12, but no differences were observed between treatment groups. With the exception of skin tightness, which was significantly greater at week 12 in the subjects who received the monotherapy, there were no significant differences between the 2 treatment groups with respect to localized irritation. Adverse events were rare in all subjects. Not only did the combination regimen result in a greater reduction of inflammatory acne lesions than use of the monotherapy but also it did not result in an increase in local irritation.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Analysis of Variance; Benzoyl Peroxide; Child; Dermatologic Agents; Drug Therapy, Combination; Female; Gels; Humans; Male; Treatment Outcome; Tretinoin

Increased sebum production is one of causes of Acne. This is under androgen control. Acne subjects have significantly greater sebum production than subjects without Acne and this relates to Acne's severity. Reduction in sebum production is associated with improvement in Acne and it can realize with anti-androgen therapy and isotretinoin therapy. But these therapies can not keep away from systematically influence. Topical retinoids do not affect sebum production and approximately 80% of tretinoin applied remains on the skin surface. Iontophoresis offer methods for enhancing the percutaneous absorption of drugs and increase of drug concentration in skin. The aim of the study was to establish possibility of improvement retinoin efficacy by iontophoresis. Our results show that application of tretinoin by iontophoresis do not affect on sebum production.

Topics: Acne Vulgaris; Adolescent; Adult; Female; Humans; Iontophoresis; Male; Sebum; Tretinoin

The efficacy and tolerability of tazarotene 0.1% gel and tretinoin 0.1% microsponge gel were evaluated in a multicenter, double-blind, randomized, parallel-group study in patients with mild-to-moderate inflammatory facial acne vulgaris. A total of 169 patients were randomized to once-daily applications of one of these topical retinoids for 12 weeks. Both agents were associated with significant reductions from baseline in the noninflammatory and inflammatory lesion counts. Tazarotene treatment was associated with a significantly greater incidence of treatment success (defined as > or = 50% global improvement [67% vs 49%; P=.03]) and significantly greater reductions in overall disease severity (36% vs 26%; P=.02) and noninflammatory lesion count (60% vs 38% at week 12; P=.02) than tretinoin microsponge treatment. Both drugs were well tolerated, with mean levels of dryness, burning, pruritus, erythema, and peeling generally being no more than trace throughout the study. There were no clinically significant between-group differences in these measures of tolerability. Two patients in each group (2%) discontinued because of treatment-related adverse events. The mean amount of medication applied by the patients was 0.28 g per application with tazarotene and 0.41 g per application with tretinoin microsponge, resulting in cost-effectiveness ratios of $81.45 per treatment success with tazarotene and $108.24 per treatment success with tretinoin microsponge. Tazarotene was observed to have greater efficacy and comparable tolerability and to be a cost-effective alternative to tretinoin 0.1% microsponge gel.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Child; Cost-Benefit Analysis; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Facial Dermatoses; Female; Gels; Humans; Male; Nicotinic Acids; Severity of Illness Index; Treatment Outcome; Tretinoin; United States

Topical retinoids are highly effective treatments for acne vulgaris. The various formulations and concentrations available allow physicians to tailor therapies to individual patient's needs and minimize the cutaneous irritation that is often observed with the use of these drugs.. To compare the efficacy and safety of tretinoin gel microsphere 0.1% with adapalene gel 0.1% in the treatment of acne vulgaris.. A 12-week double-blind study was conducted, and patients were evaluated at baseline and at weeks 2, 3, 4, 6, 8, 10, and 12.. Although the two drugs displayed similar efficacy in the resolution of acne lesions at 12 weeks, a significantly greater reduction in the number of comedones was seen at week 4 among patients treated with tretinoin gel microsphere (p = 0.047). Patients receiving tretinoin gel microsphere had an increased incidence of dryness (weeks 8 and 10) and peeling (weeks 3, 6, 8, and 10) compared with those patients treated with adapalene gel, but the two groups were comparable with respect to erythema, burning/stinging, and itching.. Both drugs have similar efficacy in the resolution of acne lesions but tretinoin gel microsphere may result in a faster onset of action in the reduction of comedones compared to adapalene.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Child; Dermatologic Agents; Double-Blind Method; Female; Gels; Humans; Keratolytic Agents; Male; Naphthalenes; Treatment Outcome; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adult; Benzoyl Peroxide; Double-Blind Method; Drug Therapy, Combination; Female; Gels; Humans; Kinetics; Liposomes; Male; Tretinoin

Tazarotene 0.1% gel and tretinoin 0.025% gel are both effective in the treatment of acne vulgaris. Results of a multicenter, double-blind, randomized, parallel-group study that compared the efficacy and tolerability of these drugs are presented here. A total of 143 patients with mild-to-moderate facial acne vulgaris were randomized to receive tazarotene 0.1% gel or tretinoin 0.025% gel once daily for 12 weeks. Tazarotene 0.1% gel was more effective than tretinoin 0.025% gel in reducing the open comedo count (P < or = .05), the total noninflammatory lesion count (P < or = .05), and the total inflammatory lesion count (not statistically significant). At some time points, tazarotene was associated with increased irritation, but peeling, erythema, dryness, burning, and itching never exceeded trace levels. We conclude that tazarotene 0.1% gel is more effective than tretinoin 0.025% gel in reducing noninflammatory lesions and similarly effective in reducing inflammatory lesions.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Double-Blind Method; Female; Gels; Humans; Keratolytic Agents; Male; Nicotinic Acids; Retinoids; Treatment Outcome; Tretinoin

Two double-blind, randomized, split-face studies have been performed to compare the facial tolerability of topical retinoids in volunteers with sensitive skin. In one study, subjects applied tazarotene 0.1% gel to one side of their face and tretinoin 0.1% gel microsponge, tretinoin 0.025% gel, or adapalene 0.1% gel to the other side of their face, for up to 29 days. Increases in facial dryness and erythema were comparable among all retinoids. Some subjects in each treatment group experienced levels of retinoid-associated irritation that required temporary suspension of, or reduction in, treatment. Facial dryness and erythema tended to be greater in these subjects than in those who tolerated the regimen without change, suggesting that the need to discontinue or modify treatment depends more on the individual than on any major inherent differences in the irritant potential of these retinoids. A second study compared once-daily versus alternate-day tazarotene 0.1% gel therapy. Tolerability was superior when initiating therapy with the alternate-day regimen.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Double-Blind Method; Gels; Humans; Keratolytic Agents; Nicotinic Acids; Retinoids; Tretinoin

A novel topical benzovl peroxide (BP) gelformulation containing liposomal BP was shown to significantly reduce local irritation relative to its nonliposomal BP gel (plain BP gel) preparation and also to improve clinical efficacy (almost twofold) in the treatment of acne. BP liposomes were prepared, optimized, and formulated into a carbopol 934gel base. Drug release evaluated using dialysis membrane has repeatedly shown that a new topical gel formulation containing liposomal BP (liposomal BP gel) significantly reduced BP penetration. Clinical evaluation data were also compared with those obtained with liposomal tretinoin (TRE) gel in an earlier investigation of ours. The overall improvement in terms of percentage reduction in total number of skin lesions demonstrated almost similar results for both BP and TRE. However, variation was observed in the treatment of separate types of lesions in which liposomal TRE gel was found to be more effective in treating comedones and liposomal BP gel in treating papules and pustules. Also, the liposomal gel formulation of both the drugs significantly reduced the local adverse effects, thereby improving patient compliance.

Topics: Acne Vulgaris; Adult; Benzoyl Peroxide; Diffusion; Drug Carriers; Drug Compounding; Female; Gels; Humans; Keratolytic Agents; Liposomes; Male; Skin; Tretinoin

To compare the efficacy, safety and tolerability of adapalene gel 0.1% vs. tretinoingel 0.025% in a Chinese patient population.. Although acne vulgaris is a common problem among Asians and Asian-Americans, little has been published on the specific manifestations, sequelae, and treatment-responsiveness of this disorder in Asian skin types. Since Asian skin types tend to be more highly pigmented than those of white people of European descent, many Asians share the predisposition toward postinflammatory hyperpigmentation seen in Africans, African-Americans and other dark-skinned peoples. It is generally assumed that the efficacy and safety of topical retinoids is the same in Asians as in white people. Tretinoin has been available in China for decades; adapalene became available in 1998.. A total of 150 patients with grade II-III acne vulgaris seen at three dermatology clinics were randomized to 8 weeks of daily treatment with either adapalene gel 0.1% or tretinoin gel 0.025%. Counts of total lesions, inflammatory lesions and non-inflammatory lesions were made at baseline and again at treatment weeks 2, 4, 6 and 8. Global assessment ratings, based on percent lesion reduction from baseline were also made. Erythema, burning, pruritus, scaling and dryness were rated on a 0-3 severity scale.. A total of 139 patients completed the efficacy evaluation, and 144 patients completed the safety evaluation. Both adapalene and tretinoin produce dramatic reductions in total, inflammatory and non-inflammatory lesion counts, in the range of 69-74% on average. More than 70% of patients in both groups had complete clearance or marked improvement. In general, irritation was mild, but was both more common and more severe in the tretinoin group vs. the adapalene group. No systemic side effects were seen.. Adapalene offers comparable efficacy to tretinoin, but is less irritating. It represents a good alternative for the treatment of mild to moderate acne vulgaris in Chinese patients.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; China; Dermatologic Agents; Drug Administration Schedule; Female; Follow-Up Studies; Gels; Humans; Male; Naphthalenes; Severity of Illness Index; Treatment Outcome; Tretinoin

A prior meta-analysis of 5 randomized controlled trials indicates that adapalene gel 0.1% is as effective as tretinoin gel 0.025% against acne and has greater tolerability. To determine the tolerability and efficacy of adapalene gel 0.1% versus tretinoin microsphere gel 0.1% in 168 patients with acne vulgaris, we conducted a 12-week, multicenter, randomized, controlled, investigator-masked, parallel-group design study. Efficacy variables included noninflammatory, inflammatory, and total lesion counts; global grade; and global assessment of improvement in acne severity. Skin tolerability variables included erythema, desquamation (scaling), dryness, pruritus, and stinging/burning. Our results showed that the efficacy of adapalene gel 0.1% was comparable to that of tretinoin microsphere gel, and both treatments had similar onset of action. Cutaneous tolerability was noted in both groups, with scores significantly better with adapalene gel 0.1% than with tretinoin microsphere gel 0.1%, and significantly fewer treatment-related adverse events were reported with adapalene gel 0.1%.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Child; Dermatologic Agents; Female; Humans; Keratolytic Agents; Male; Naphthalenes; Sensitivity and Specificity; Treatment Outcome; Tretinoin

Poor patient compliance is one of the main reasons for treatment failure in acne. Our objective was to evaluate the tolerability and patient preference of adapalene gel 0.1% compared with tretinoin microsphere gel 0.1% using a randomized, controlled, investigator-masked, bilateral (split-face), 4-week comparative study of the 2 products when applied once daily in 40 patients. We found that adapalene produced less stinging/burning than tretinoin at weeks 1 and 4 and, overall, more patients felt more skin irritation on the side of the face treated with tretinoin than on the side treated with adapalene (P<.05). At week 4, a significantly greater number of patients preferred adapalene gel 0.1% to tretinoin microsphere gel 0.1% (72.5% vs 27.5%, respectively, P<.01).

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Dermatologic Agents; Female; Humans; Keratolytic Agents; Male; Naphthalenes; Patient Satisfaction; Treatment Outcome; Tretinoin

Acne vulgaris is a common dermatologic disease in Asian populations, as well as in Caucasians. Our objective was to evaluate the safety and efficacy of adapalene gel 0.1% in comparison with tretinoin gel 0.025% in Chinese patients with acne vulgaris. We used an 8-week, multicenter, randomized, controlled, investigator-masked, parallel group design study of adapalene gel 0.1% and tretinoin gel 0.025% in 150 Chinese patients with mild-to-moderate acne vulgaris. Our results showed that adapalene gel 0.1% had efficacy equivalent to tretinoin gel 0.025% against acne lesions in Chinese patients, with a more acceptable tolerability profile.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; China; Female; Humans; Keratolytic Agents; Male; Naphthalenes; Sensitivity and Specificity; Treatment Outcome; Tretinoin

The good efficacy and tolerability of an alcoholic erythromycin/tretinoin solution was confirmed in a multicentre data investigation of over 6500 patients. The mean score for comedones declined clearly from 1.9 to 0.9 during treatment (average duration 70 days). The score for papules and pustules was reduced from 1.6 to 0.5. Overall medical assessment indicated 'very good' to 'good' efficacy in 86.1% of documented cases. Adverse drug reactions during treatment were mostly only very mild and were nearly always the known symptoms of redness, scaling, dryness and itching. Overall assessment of tolerability was 'very good' or 'good' in 88.1% of cases.

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Antineoplastic Agents; Dermatology; Drug Therapy, Combination; Erythromycin; Female; Germany; Humans; Male; Product Surveillance, Postmarketing; Tretinoin

Tretinoin gel microsphere, 0.1%, is a highly effective anti-acne medication formulated with sponge-like microspheres encapsulating the active ingredient, tretinoin. In addition to minimizing cutaneous irritation, this system may also reduce facial shine. This single-center, double-blind, half-face study evaluated the potential of tretinoin gel microsphere, 0.1%, to reduce the appearance of facial shine compared to tretinoin cream, 0.025%. Thirty-five subjects (ages 12 to 24 years) with moderate acne vulgaris and moderate facial oiliness, were evaluated after 4 consecutive days of product use. On sides treated with tretinoin gel microsphere, 0.1%, investigators found significantly reduced facial shine at 3 and 6 hours posttreatment. Subjects' self-evaluations revealed a significant reduction in facial shine at 3 hours posttreatment. Photographic analyses showed reductions in facial shine for both treatments, but decreases were greater on tretinoin gel microsphere, 0.1%-treated sides. Both therapies were well tolerated, and no adverse events occurred. Tretinoin gel microsphere, 0.1%, has the added benefit of reducing the appearance of facial shine, which is a frequent concern in acne patients.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Child; Double-Blind Method; Face; Female; Gels; Humans; Keratolytic Agents; Lipids; Male; Ointments; Skin; Tretinoin

A successful phase III pilot study compared the efficacy and safety of a fixed clindamycin 1%/tretinoin 0.025% gel formulation (CTG; Velac gel) applied once daily and a clindamycin 1% lotion formulation (CLN; Dalacin T lotion) applied twice daily in the treatment of moderate to severe acne vulgaris.. We aimed to follow up this study.. The two treatment regimens were compared in a multicentre, single-blind, randomized 12-week investigation of patients with moderate to severe acne vulgaris.. At week 12, the mean percentage reduction in non-inflamed lesions (open and closed comedones) was greater in the CTG group compared with the CLN group (P = 0.05). Absolute reductions in open and closed comedones were also greater in the CTG group, consistent with the comedolytic activity of tretinoin. There was a significantly greater absolute reduction in inflamed lesions (pustules, papules and nodules) from baseline to both end-point (last observed efficacy outcome; P = 0.043) and week 12 (P = 0.018) in the CTG group compared with the CLN group. Evaluation of the calculated overall acne severity score, considering all five lesion subtypes, demonstrated a significantly greater mean percentage reduction in the CTG group compared with the CLN group, both at end-point (P = 0.01) and at week 12 (P < 0.01). The more subjective assessment of overall acne severity according to the Cook scale also demonstrated a significantly greater mean reduction in the CTG group than the CLN group after 12 weeks of therapy (P = 0.007). CTG had a more rapid effect on the onset of improvement compared with CLN; a 50% reduction in total lesion counts by day 60 was found in 77% of patients on CTG compared with 56% receiving CLN (P = 0.003). This was largely due to the reduction in open comedone counts (P = 0. 0006). For all other variables, CTG was at least as effective as CLN. Both treatments were well tolerated.. A single daily topical application of Velac gel was superior to Dalacin T lotion applied twice daily in reducing overall acne scores, and was faster acting. The simpler dosing regimen of Velac gel and its rapid effect are likely to have a positive effect on both patient compliance and cost.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Anti-Bacterial Agents; Clindamycin; Drug Combinations; Female; Humans; Male; Patient Compliance; Severity of Illness Index; Single-Blind Method; Treatment Outcome; Tretinoin

An attempt was made to pharmaceutically develop a topical liposomal tretinoin (TRE) gel and clinically evaluate the developed formulation for the treatment of acne in patients. Liposomes of TRE were prepared using the lipid film hydration technique and the entrapment efficiency of TRE in liposomes was optimized to 79.96%. The drug retention in liposomes and in liposomal TRE gel (Carbopol 934 gel base) studied at three storage conditions indicated maximum drug retention at refrigeration temperature. For liposomal TRE gel, reduced drug leakage was observed as compared to that of liposomes at all three storage conditions. Diffusion studies of plain TRE gel and liposomal TRE gel suggested prolongation (3.4 times reduction in flux value) of drug diffusion and almost two-fold increase in skin drug retention after liposomal encapsulation of drug. A comparative double-blind clinical study of the developed liposomal TRE gel, carried out on 30 acne patients over a period of 3 months, demonstrated significant enhancement (about 1.5-fold) in drug efficacy. More remarkable improvement was observed in the treatment of comedones, where the mean percent reduction in lesions increased from 62.36% for plain TRE gel to 94.17% for liposomal TRE gel. Erythema and irritation associated with the use of plain TRE gel was reduced considerably with the use of liposomal TRE gel. The findings of this investigation therefore underscore potential utility of commercialization of liposomal TRE gel in the treatment of acne.

Topics: Acne Vulgaris; Adolescent; Adult; Animals; Diffusion; Double-Blind Method; Female; Gels; Humans; Liposomes; Male; Tretinoin

Adapalene and tretinoin are topical compounds active for treating acne.. To compare the efficacity and safety of adapalene 0.1% gel and tretinoin 0.05% gel in moderately severe facial acne using clinical and objective biometrological assessments. Such information is currently lacking in the literature.. The split-face method was used in 25 acne volunteers for a 6-week treatment. In addition to clinical counts of lesions, the amount of comedones was assessed using computer-assisted morphometry of cyanoacrylate follicular biopsies. The erythema index and squamometry values were used to quantitate skin irritation.. The tretinoin formulation brought better comedolysis and clinical improvement than the adapalene formulation. Erythema was transiently more pronounced on the tretinoin-treated side. Squamometry yielded no significant difference between both products.. Tretinoin 0.05% gel exhibits a greater anti-acne efficacy than adapalene 0.1% gel, although with temperate tolerability.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adult; Dermatologic Agents; Facial Dermatoses; Humans; Keratolytic Agents; Male; Naphthalenes; Single-Blind Method; Skin; Tretinoin

This is a clinical, prospective, and longitudinal study comparing the efficacy and incidence of averse effects of topical isotretinoin against those of topical retinoic acid in the treatment of acne vulgaris. The 30 participants were recruited from the patients attending the outpatient clinic of the Department of Dermatology of "Dr Manuel Gea González" General Hospital in Mexico City. They belonged to either sex and any race, their ages ranged between 13 and 30 years, and they presented with 15 to 100 facial inflammatory lesions (papulo-pustules) and/or 15 to 100 noninflammatory lesions (comedones) and no more than three nodulo-cystic lesions. The criteria of exclusion were as follows: pregnancy or lactation, systemic treatment with steroids, antibiotics, antiandrogens, or oral retinoids in the preceding 24 months, treatment with ultraviolet radiation, hypersensitivity to retinoids, or a severe systemic illness. From 44 interviewed patients, 14 were excluded. A detailed clinical history was obtained from the remaining individuals, the degree of seborrhea was recorded, and acne lesions were counted. Each patient received either isotretinoin gel 0.05% or retinoic acid cream 0.05%. The patients were instructed to wash their faces in the mornings and evenings with a neutral soap, and to apply the product after the evening cleansing. The patients were examined again after 2, 4, 8, and 12 weeks of treatment and, at each appointment, the number of lesions was recorded and the severity of acne was graded according to the classification of Plewig and Kligman. The seriousness of the adverse effects, such as stinging, pruritus, erythema, xerosis, and desquamation, was evaluated blindly by an investigator who did not know what group the patient belonged to, and graded as 1 = mild, 2 = moderate, and 3 = severe. The efficacy of each drug was determined by the reduction in the number of lesions between weeks 0 and 12 of treatment. An excellent response corresponded to a 76%-100% reduction of the lesions, a good response to a 51%-75% reduction, a fair response to a 26%-50% reduction, and a poor response to a 0%-25% reduction. The results were analyzed statistically using the chi-square test, the exact test of Fisher and the test of Wilcoxon-Mann-Whitney. The changes in the numbers of lesions between weeks 0 and 12 were analyzed separately for each group of treatment, and the level of statistical significance was fixed at 0.05. The analysis was performed with the aid of a. The patients were assigned randomly to either Group I (isotretinoin) or Group II (retinoic acid). Each group was composed of 15 individuals and, as a coincidence, in each group there were nine women and six men. The clinical differences between the groups at the first visit were not statistically significant. In both groups, there was, in general, a good response to treatment (Fig. 1). Both drugs had a similar degree of efficacy on inflammatory lesions. At the first visit, grades III and IV predominated, whereas, after 12 weeks of treatment, most patients were classified in grades I or II (Fig. 2). Similar results were observed regarding noninflammatory lesions (Fig. 3). Ten of the patients of Group II complained of stinging associated with the treatment, especially at weeks 8 and 12, as well as erythema and desquamation at the 12th week. Erythema and stinging lasted for minutes or hours, whereas desquamation persisted for several days. Seven individuals receiving isotretinoin mentioned irritation, which was of a mild degree.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Dermatitis, Irritant; Erythema; Female; Humans; Isotretinoin; Keratolytic Agents; Longitudinal Studies; Male; Prospective Studies; Severity of Illness Index; Skin; Time Factors; Treatment Outcome; Tretinoin

The addition of polyolprepolymer-2 in tretinoin formulations may reduce tretinoin-induced cutaneous irritation.. This study compared the efficacy and safety of a new 0.025% tretinoin gel containing polyolprepolymer-2, its vehicle, and a commercially-available 0.025% tretinoin gel in patients with mild to moderate acne vulgaris.. In this 12-week multicenter, double-blind, parallel group study, efficacy was evaluated by objective lesion counts and the investigators' global evaluations. Subjective assessment of cutaneous irritation by the investigators and patients evaluated safety.. The efficacy of the two active treatments in this 215 patient study was comparable, and both treatments were statistically significantly more effective than vehicle. When compared with the commercially-available tretinoin gel, the formulation containing polyolprepolymer-2 demonstrated statistically significantly less peeling at days 28, 56, and 84, statistically significantly less dryness by day 84, and statistically significantly less itching at day 14. Irritation scores for the formulation containing polyolprepolymer-2 were numerically lower but not statistically different from those of the commercially-available gel for erythema and burning. The number of cutaneous and noncutaneous adverse events were similar for both active medications.. The two 0.025% gels studied demonstrated comparable efficacy. However, the gel formulation containing polyolprepolymer-2 caused significantly less peeling and drying than the commercially-available formulation by day 84 of the study.

Topics: Acne Vulgaris; Administration, Topical; Adult; Double-Blind Method; Female; Gels; Humans; Keratolytic Agents; Male; Ointments; Polypropylenes; Polyurethanes; Tretinoin

Preclinical study and human patch tests indicate polyolprepolymer-2 may reduce cutaneous tretinoin-induced irritation.. This study compared the clinical efficacy and safety of a 0.025% tretinoin cream containing polyolprepolymer-2 and its vehicle to a commercially-available 0.025% tretinoin cream.. In this 12-week multicenter, double-blind, parallel group study in patients with mild to moderate acne, objective lesion counts and the investigators' global evaluations evaluated efficacy. Subjective evaluations of skin irritation were used to study safety.. A total of 271 patients were enrolled. The active treatments demonstrated comparable efficacy that was statistically significantly greater than that of the vehicle. Safety evaluations of cutaneous and noncutaneous adverse events also indicated comparable results of the active treatments.. The commercially-available 0.025% tretinoin cream and the 0.025% tretinoin cream containing polyolprepolymer-2 demonstrated comparable efficacy and safety.

Topics: Acne Vulgaris; Administration, Topical; Adult; Double-Blind Method; Female; Humans; Keratolytic Agents; Male; Ointments; Polypropylenes; Polyurethanes; Tretinoin

The percutaneous absorption of clindamycin was studied in healthy male volunteers, comparing two investigative clindamycin (% w/v)/tretinoin (0.025% w/v) gels, containing clindamycin phosphate ester and clindamycin HCl, respectively, relative to a clindamycin phosphate lotion (1% clindamycin; Dalacin T). Formulations were applied daily for 5 days on the face, according to a balanced complete block design. Redness of the skin was scored visually, and blood and urine were collected. Clindamycin plasma levels did not exceed the limit of quantification (5 ng mL(-1)) with the clindamycin phosphate formulations, but one volunteer who received the clindamycin HCl/tretinoin gel showed plasma levels of up to 13 ng mL(-1). Clindamycin urinary excretion for 12 h after application of the clindamycin phosphate/tretinoin gel was comparable to the values of the reference lotion, whereas the clindamycin HCl/tretinoin gel gave significantly higher values. Erythema appeared to be associated with increased urinary excretion. The formulations were tolerated well. In a separate clinical pilot study in acne patients, the transdermal uptake of tretinoin and clindamycin from the clindamycin phosphate/tretinoin gel was monitored. Plasma samples were collected after 4 and 12 weeks of daily treatment. None of the study plasma samples contained measurable tretinoin levels. Clindamycin levels were not quantifiable in the majority (87%) of samples, the highest plasma level was 11 ng mL(-1). The chemical form of clindamycin proved to modulate skin irritation and percutaneous uptake of clindamycin from a gel formulation in healthy subjects. There was no indications for a notable transdermal uptake of tretinoin during daily application of the gel in patients, nor for an enhancing effect of tretinoin on clindamycin uptake.

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Anti-Bacterial Agents; Chemistry, Pharmaceutical; Clindamycin; Drug Therapy, Combination; Erythema; Gels; Humans; Keratolytic Agents; Male; Pilot Projects; Skin Absorption; Tretinoin

A formulation containing agents affecting the non-inflammatory as well as the inflammatory lesions of acne vulgaris at the same time would be efficient, probably showing a high efficacy and possibly a considerable shortening of the duration of treatment. One single formulation would simplify drug administration thereby enhancing patient compliance and possibly leading to improved therapeutic results. In two studies this seems to have been corroborated for the fixed clindamycin phosphate-tretinoin gel formulation.. This study was designed to assess whether the recently developed fixed formulation of 1.2% clindamycin phosphate and 0.025% tretinoin in a gel base (Velac), further referred to as Clindamycin phosphate Tretinoin Gel is at least as effective as a proprietary 0.025% tretinoin gel formulation (Aberela, Janssen Cilag Ab, Sollentuna, Sweden; further defined as tretinoin) showing an additional anti-inflammatory effect in the treatment of moderate to severe acne vulgaris.. In a double-blind, randomised study 72 patients were treated with CTG and 73 with tretinoin gel in a once daily regimen for 12 weeks. Responses, irritation as well as possible systemic and other adverse effects were recorded after 4, 8 and 12 weeks of treatment and the improvement, compared to baseline, assessed in all included patients. An additional assessment of the safety parameters was carried out at week 2. Parameters of efficacy were the various acne lesion counts, the overall acne severity grade and the calculated totals of acne lesion counts.. CTG was statistically significantly more effective than tretinoin at the P = 0.05 level in the papular and the total mean inflammatory lesion counts as well as in the estimated or calculated mean overall acne severity scores. CTG and tretinoin gel were equally effective in the remaining parameters: open and closed comedones, the calculated total mean comedone, the pustule as well as the nodule lesion counts. The onset of action was faster for CTG than for tretinoin gel and evident in all assessed parameters except in open comedone lesion counts. In the calculated total mean acne lesion counts, half of all acne lesions had disappeared by week 6 of treatment with CTG, whereas this was recorded at week 9 for tretinoin gel. No clinically relevant changes in the parameters of safety as a consequence of treatment were observed, although the burning component of irritation was shown to be significantly less for CTG than for tretinoin gel. The observed adverse effects were considered minor. Treatment had to be discontinued in five patients on CTG and three on tretinoin.. The addition of clindamycin to tretinoin, as in CTG, enhances the comedolytic efficacy of tretinoin in moderate to severe acne of the face, maintaining at the same time its anti-inflammatory efficacy thus accelerating resolution of all types of acne lesions without affecting the safety of response to both components.

Topics: Acne Vulgaris; Adolescent; Adult; Clindamycin; Double-Blind Method; Drug Combinations; Facial Dermatoses; Female; Gels; Humans; Male; Treatment Outcome; Tretinoin

One hundred patients with acne vulgaris applied adapalene (Differin) 0.1% gel to one side of their face and tretinoin 0.025% cream to the other once a day for 4 weeks; the side of application was determined by randomization code. Patient tolerance (assessed as the side of the face least irritated by drug application) was recorded weekly and patient preference (assessed as the preparation more easily spread, absorbed more quickly, smelled better, felt best on the skin and least greasy to the feel) at completion of the study. The investigator measured skin irritation weekly, scoring erythema, skin dryness, desquamation and burning/stinging on a 10-point scale. After each week of treatment, 64-68% of patients found adapalene 0.1% gel more tolerable than tretinoin 0.025% cream (P < 0.05). At study completion, 65% of patients preferred adapalene 0.1% gel over tretinoin 0.025% cream (P = 0.003). An overall assessment showed adapalene 0.1% gel was significantly less irritating to the skin in terms of producing erythema, dryness, desquamation and burning/stinging, at Visits 2, 3 and 4 (P < 0.02). Thirty-two patients experienced mild to moderately severe adverse events; three had adverse events considered to be drug related (two with skin discomfort; one with skin dryness). One patient stopped using the study drugs because of dry skin. This study showed that a majority of patients preferred adapalene 0.1% gel over tretinoin 0.025% cream and that it caused significantly less skin irritation.

Topics: Acne Vulgaris; Adapalene; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Drug Eruptions; Female; Gels; Humans; Keratolytic Agents; Male; Naphthalenes; Ointments; Patient Satisfaction; Tretinoin

A randomized, multicentre, investigator-masked study was conducted in 105 patients with mild to moderate acne vulgaris to compare the efficacy and safety of adapalene 0.1% gel with tretinoin 0.025% gel after three months of treatment, with particular emphasis on reduction in inflammatory lesion counts after one week of treatment and impact on quality of life. In terms of efficacy, adapalene gel was found to be superior to tretinoin gel after one week of treatment, with respect to reduction in inflammatory lesion counts (32% vs. 17%, respectively; P = 0.001), total lesion counts (28% vs. 22%, respectively; P = 0.042) and global severity grade (28% vs. 16%, respectively; P = 0.001). No significant difference between the two treatments was found after 12 weeks of treatment for any of these variables. Evaluation of facial skin tolerance parameters showed significant differences between the two treatments in favour of adapalene for dryness, erythema, immediate and persistent burning and pruritus for at least one time point. One patient in the adapalene group and three patients in the tretinoin group experienced medical events which lead to discontinuation of treatment (skin irritation; NS). Quality of life scores improved more rapidly in the adapalene group than in the tretinoin group, with significant differences (P < 0.05) appearing at week 1 for questions related to problems with partners, close friends or relatives and to skin symptoms. There was also a significantly greater improvement in social and leisure activity in the adapalene group at week 12. Adapalene 0.1% gel reduced inflammatory and total lesion counts more rapidly than tretinoin 0.025% gel, and was also better tolerated. These differences appear to result in an earlier and greater quality of life improvement for the patients receiving adapalene.

Topics: Acne Vulgaris; Adapalene; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Child; Double-Blind Method; Drug Eruptions; Female; Humans; Keratolytic Agents; Male; Naphthalenes; Quality of Life; Treatment Outcome; Tretinoin

Adapalene 0.1% gel (Differin gel) is a recently introduced topical treatment for mild to moderate acne which has been demonstrated to be much better tolerated and at least as effective as tretinoin 0.025% gel. We compared the tolerance of adapalene 0.1% gel with six different formulations and concentrations of tretinoin. A total of 55 healthy human subjects were enrolled in two controlled, randomized, observer blinded, intraindividual comparison studies. In the first study, adapalene 0.1% gel was evaluated for its 21-day cumulative irritation potential compared with tretinoin 0.025%, 0.05% and 0.1% cream, tretinoin 0.01% and 0.025% gel, and petrolatum (control). In the second study, adapalene 0.1% gel was evaluated for its 21-day cumulative irritation potential compared with tretinoin 0.025%, 0.05% and 0.1% cream, tretinoin 0.1% gel microsphere, and petrolatum (control). In both studies, cumulative irritation scores helped to define three groups of common irritancy potential, with significant differences between each group. In study A, the three groups were in descending order of irritancy: tretinoin 0.1% cream and tretinoin 0.05% cream; tretinoin 0.025% gel, tretinoin 0.01% gel and tretinoin 0.025% cream; adapalene 0.1% gel and petrolatum (control). In study B, the three groups were in descending order of irritancy: tretinoin 0.1% cream; tretinoin 0.05% cream, tretinoin 0.025% cream and tretinoin 0.1% gel microsphere; adapalene 0.1% gel and petrolatum (control). The experimental results show that adapalene 0.1% gel is significantly better tolerated than any of six formulations of tretinoin, including two gels, three creams and a microsphere formulation, ranging in potency from 0.01% to 0.1%.

Topics: Acne Vulgaris; Adapalene; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Drug Eruptions; Female; Gels; Humans; Keratolytic Agents; Male; Middle Aged; Naphthalenes; Ointments; Tretinoin

A multicentre study was conducted to compare clinical safety and efficacy of adapalene 0.1% solution and tretinoin 0.025% gel, both topical treatments for acne, in a once-daily dosage regimen for 12 weeks. A total of 297 patients were enrolled by eight investigators in this randomized, investigator-masked study in a parallel group design. An open label period using adapalene followed this study to assess the long-term safety of adapalene solution. Adapalene and tretinoin proved to be clinically and statistically effective in treating acne by reducing inflammatory (47% and 50%, respectively) and non-inflammatory lesions (57% and 54%) as compared to baseline. When comparing patients who had 75% or greater improvement in open comedones, adapalene was shown to be significantly more effective than tretinoin. No serious adverse event was reported during this study, including during the long-term period. The reactions that occurred were similar between treatments, i.e. burning, pruritus, scaling, dryness and erythema.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Child; Double-Blind Method; Drug Eruptions; Female; Gels; Humans; Keratolytic Agents; Male; Naphthalenes; Treatment Outcome; Tretinoin

Adapalene is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris.. We describe the results of a combined safety analysis of two multicenter trials conducted in the U.S. and Europe in which adapalene 0.1% gel was compared with tretinoin 0.025% gel in the treatment of mild to moderate acne vulgaris.. A total of 591 acne patients were enrolled in these investigator-masked, randomized, controlled, parallel group studies. In the two studies, each patient was randomly assigned to receive topical adapalene 0.1% gel or tretinoin 0.025% gel once daily at bedtime, for 12 weeks. In addition to assessments of efficacy and facial skin tolerance, data on adverse events were recorded at each visit or at any other time the patient reported problems. We extracted data concerning adverse reactions (i.e., adverse events judged to be related to the study treatment) from both studies and combined the results to obtain a global comparison of safety of the two products.. A total of 15 of 296 patients (5.1%) reported 19 adverse reactions in the adapalene-treated groups, compared with 27 of 295 patients (9.1%) reporting 39 adverse reactions in the tretinoin-treated groups (p < 0.05). The number of patients discontinuing the study because of adverse events was approximately twice as low with adapalene (1.3% compared with 2.4%). Most adverse reactions for both products were related to skin irritation. No systemic adverse reactions were reported.. The results of these two multicenter clinical studies indicate that adapalene gel is better tolerated than tretinoin gel.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Child; Female; Humans; Keratolytic Agents; Male; Naphthalenes; Skin; Treatment Outcome; Tretinoin

Adapalene is a new synthetic retinoid analogue developed for the topical treatment of acne vulgaris.. The study was designed to compare the efficacy and safety and adapalene gel 0.1% with tretinoin gel 0.025% in the treatment of grade II to II facial acne vulgaris.. Three hundred twenty-three patients were enrolled in this investigator-masked, randomized, parallel group, multicenter trial. Patients applied the test materials to the entire facial area daily, for a period of 12 weeks. Efficacy and cutaneous tolerance were assessed at baseline and weeks 2,4,8, and 12. Efficacy was determined by investigator counts of noninflammatory open and closed comedones, and inflammatory papules and pustules, as well as global improvement. Cutaneous tolerance was evaluated by erythema, scaling, and dryness, along with burning and pruritus.. Staring at weeks 2 and 4, adapalene gel produced numerically greater lesion reductions than did tretinoin gel for all lesion types. At week 12, the mean percent reduction in the different lesion counts was as follow: 49% versus 37% for total lesions (p<0.01); 46% versus 33% for noninflammatory lesions (p=0.02); 48% versus 38% for inflammatory lesions (p=0.06) in adapalene and tretinoin gel treatment groups, respectively. Cutaneous side effects were limited to a mild "retinoid dermatitis" occurring in both treatment groups; however, patients treated with adapalene gel tolerated this therapy significantly better than those treated with tretinoin gel. Laboratory test evaluations (hematology, blood chemistries, urinalysis) were performed in 54 patients before and after 3 months of treatment. No clinically significant changes were observed.. Adapalene gel 0.1% applied once daily was significantly more effective in reducing acne lesions and was better tolerated than tretinoin gel 0.025% in the treatment of acne vulgaris.

Topics: Acne Vulgaris; Adapalene; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Child; Drug Eruptions; Drug Tolerance; Erythema; Facial Dermatoses; Female; Gels; Humans; Keratolytic Agents; Male; Naphthalenes; Pruritus; Single-Blind Method; Skin Diseases; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Double-Blind Method; Forehead; Humans; Isotretinoin; Keratolytic Agents; Male; Sebum; Skin; Tretinoin

Adapalene is a new chemical entity with retinoid activity.. 0.1 p. 100 adapalene gel (Différine gel), 0.03 p. 100 adapalene gel and a commercially available 0.025 p. 100 tretinoin gel (Aberel gel) were compared in 89 male and female patients with acne.. Inflammatory, non inflammatory, total lesion counts, and the global facial acne grade regularly decreased as a function of time in the three treatment groups. No statistically or clinicaly significant differences were observed for these parameters between 0.1 p. 100 adapalene gel and 0.025 p. 100 tretinoin gel following a 12-week treatment. Conversely, both of these gels were significantly more effective than 0.03 p. 100 adapalene gel with regards to inflammatory and total lesion counts, and the global facial acne grade. The differences of efficacy seen between both adapalene gels demonstrate a dose-dependent activity of the drug in the topical treatment of acne. The three products induced retinoid-like skin irritation with significant differences in intensity in favour of adapalene for erythema, dryness, scaling and burning after application and in favour of tretinoin for persistent burning. No treatment-related medical events were reported and adapalene plasma levels were lower than 0.15 ng/ml (limit of detection of the analytical method).. The topical treatment of acne with adapalene gels was found to be safe and effective, with a dose-related response. The efficacy of 0.1 p. 100 adapalene gel and of 0.025 p. 100 tretinoin gel are not different but skin tolerance of 0.1 p. 100 adapalene gel is superior.

Topics: Acne Vulgaris; Adapalene; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Female; Gels; Humans; Keratolytic Agents; Male; Naphthalenes; Time Factors; Tretinoin

9-cis-Retinoic acid (9-cis-RA) is as active as 13-cis-retinoic acid (13-cis-RA) in inhibiting the proliferation of cultured human sebocytes and in reducing the size of sebaceous glands of hamsters.. Evaluate the anti-acne effect of 9-cis-RA compared to that of 13-cis-RA in a pilot study.. Four young male patients with acne were treated in an open study consecutively with 9-cis-RA and 13-cis-RA given at similar doses.. No beneficial effects were observed with 9-cis-RA in any of the patients whereas all responded favorably to 13-cis-RA.. For the two retinoids tested, the anti-acne effect correlates with the sebosuppressive effect in humans.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Alitretinoin; Animals; Cells, Cultured; Cricetinae; Disease Models, Animal; Humans; Isotretinoin; Keratolytic Agents; Male; Pilot Projects; Retinoids; Sebaceous Glands; Sebum; Treatment Outcome; Tretinoin

It is generally accepted that the inhibition of sebum excretion has a predictive value for anti-acne activity. Whereas oral 13-cisretinoic acid (13-cis-RA) decreases sebum excretion, it has not been shown so far if oral all-trans-retinoic acid (tretinoin, tRA) does so. The aim of this exploratory study was to investigate the effect of oral tRA on the sebum excretion rate (SER) in young male subjects.. 12 healthy volunteers with a baseline SER above 1.0 microgram/cm2/min were treated with 20 mg/day tRA for 4 weeks. The SER was measured at weeks 2 and 4. Adverse reactions were recorded.. The mean SER varied from 1.56 at baseline to 1.65 at week 2 and to 1.49 micrograms/cm2/min at week 4. Comparison with values obtained in the same subjects previously treated with either 13-cis-RA or 9-cis-retinoic acid indicated that tRA less sebosuppressive. Mucocutaneous reactions and headache were the most frequent side effects of oral tRA.. The lack of effect on the SER suggests that oral tRA would probably be ineffective against acne. The fact that, of the three isomers tested, only 13-cis-RA (which does not bind to nuclear receptors) shows activity may suggest that sebosuppression is not nuclear receptor mediated. We discuss other hypotheses related to pharmacokinetics.

Topics: Acne Vulgaris; Administration, Oral; Adult; Alitretinoin; Drug Eruptions; Facial Dermatoses; Headache; Humans; Isotretinoin; Keratolytic Agents; Lip Diseases; Male; Mucous Membrane; Retinoids; Sebum; Skin; Tretinoin

Common treatment of atrophic acne scars consists of invasive methods such as dermabrasion, chemopeeling, or implantation of bovine collagen. In our study a new noninvasive treatment method consisting of local iontophoresis is demonstrated. Local iontophoresis was performed with either estriol--a mainly topically active estrogen--or with tretinoin.. Eighteen women were treated with estriol iontophoresis twice weekly for a period of 3 months. In addition to photographic and clinical documentation of the skin, venous blood for determination of serum levels of prolactin and estradiol according to standard radioimmunoassay methods was obtained monthly. Tretinoin iontophoresis was performed according to the same time schedule in 28 patients (19 women and 9 men) with atrophic acne scars.. Improvement of acne scars was observed in 93% of patients treated with tretinoin iontophoresis and in 100% of the group treated with estriol iontophoresis. No hormonal changes were noted in the estrogen group. Side effects involving the skin appeared in the tretinoin group in 4 cases and consisted of increased dryness and of retinoid dermatitis.. Both treatments were shown to be clinically effective in decreasing acne scars and persistence of effects. This promising new therapeutic approach may thus replace invasive treatment methods in many patients.

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Atrophy; Cicatrix; Drug Eruptions; Estradiol; Estriol; Facial Dermatoses; Female; Follow-Up Studies; Humans; Iontophoresis; Male; Prolactin; Skin; Skin Diseases; Tretinoin

Frequently occurring skin irritancy and flare-up reactions impede the use of topical tretinoin for acne vulgaris due to poor patient compliance. Liposome encapsulation improves penetration into the skin and local tolerability in animals. We investigated efficacy and local tolerability of liposomal tretinoin in man. In a double-blind study 20 patients with uncomplicated acne vulgaris received liposomal tretinoin (0.01%) on one side of the body and a commercial gel preparation with either 0.025% or 0.05% on the other once daily for 10 weeks. Comedones and papules/pustules were counted every 2 (-4) weeks. Then also redness, scaling, and burning were rated according to a four-point scale. Moreover, the patients noted skin irritancy in a diary on a daily base. With conventional tretinoin the gels were equally efficacious and equally well tolerated. Liposomal tretinoin also appeared equipotent to the reference gels. There may even have been a slightly more rapid clearing of comedones following the liposome preparation. With respect to skin irritancy, however, liposomal tretinoin was superior. As rated by the patients, liposome encapsulated tretinoin induced less burning (mean cumulative score 2.7 +/- 1.2) than the 0.025% gel (16.1 +/- 7.1) and the 0.05% gel (9.7 +/- 4.1) gel and less erythema (1.8 +/- 0.7) than the 0.025% gel (11.4 +/- 3.8; (P < 0.05). Liposomal tretinoin was also better tolerated according to the rating by the investigator. Liposomal encapsulation of tretinoin allows reduction of the concentration of the active agent without a decline in efficacy for acne vulgaris. Since local tolerability is thus increased, liposomal tretinoin should favor the acceptance of this treatment by the patient.

Topics: Acne Vulgaris; Adolescent; Adult; Double-Blind Method; Drug Carriers; Female; Humans; Irritants; Liposomes; Male; Pilot Projects; Treatment Outcome; Tretinoin

Two consecutive studies were performed with the aim of clearly defining the optimal physical treatment for closed comedones. The first 10 patients with clinically significant numbers of facial comedones were treated with fulguration under EMLA anaesthesia on one side of the face and topical tretinoin on the opposite side. At the end of the study fulguration was shown to be significantly (p = 0.005) superior to topical tretinoin. A direct comparison of light electrocautery using EMLA anaesthetic with fulguration without anaesthesia was then performed on 12 patients. The comedones were subdivided by size into those that were approximately 1 mm or less in diameter and those of greater dimensions. In the treatment of larger comedones electrocautery was shown to be significantly superior to fulguration (p = 0.025), but there was no significant difference in the efficacy of the treatments for the smaller lesions.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Electrocoagulation; Female; Humans; Male; Treatment Outcome; Tretinoin

CD 271, a naphthoic acid, is a powerful modulator of epidermal differentiation. This double-blind, randomized study compared the efficacy and safety of two concentrations (0.03% w/w and 0.1% w/w) of CD 271 alcoholic gel, with 0.025% w/w tretinoin gel in 72 male patients with acne vulgaris over a period of 12 weeks. Efficacy was measured by counting facial inflammatory and non-inflammatory lesions and by grading the severity of the acne at each visit. Skin tolerance was assessed with subjective symptoms, such as burning and pruritus, as well as clinical assessment of erythema, dryness and scaling on the treated areas. The alcoholic 0.1% CD 271 gel was as effective as 0.025% tretinoin gel in reducing total comedone counts (83% reduction for both products after 12 weeks' treatment). The reduction in the number of inflammatory lesions and the total number of acne lesions were significantly greater with 0.1% CD 271 gel than with tretinoin gel (69% and 79% for 0.1% CD 271, 50% and 73% for tretinoin gel, respectively, P less than 0.05). All three treatments were well tolerated and there were no changes in any major blood parameters. No CD 271 could be detected in blood plasma at the end of the study (detection limit = 1 ng/ml).

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Humans; Male; Naphthalenes; Tretinoin

Since 1982, systemic Roaccutan has been used to treat acne that is resistant to traditional therapy. The treatment produces certain side effects and a potential for teratogenesis. The result has been worldwide reports of a number of malformed and abnormal infants. In the present questionnaire presented to 94 Norwegian women of child-bearing potential, no pregnancy occurred during the treatment period. Before start of treatment, all patients agreed to have an abortion if conception occurred during treatment. The article discusses the type of contraception, the quality of information and the effect of treatment upon the acne condition. The study confirms the importance of Roaccutan in the treatment of cystic acne, and shows that the Norwegian prescription routine for Roaccutan is adequate.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Female; Humans; Middle Aged; Pregnancy; Risk Factors; Tretinoin

We have evaluated the in vivo effects of 13-cis retinoic acid (13-cis RA) on human antibody responses to immunization with tetanus toxoid (TT) and keyhole limpet hemocyanin (KLH). Subjects with severe cystic acne were immunized with suboptimal doses (10 micrograms) of KLH 7 d and 3 months after starting retinoid therapy (13-cis RA, 1 mg/kg/day for 4 mo). A standard booster immunization with TT was given along with the initial KLH sensitization. A control group of acne patients received identical immunization regimens, but no 13-cis RA. Plasma retinoid levels were evaluated by reverse-phase HPLC and confirmed that blood-level concentrations of 13-cis RA and metabolites in these acne patients reached values previously demonstrated to be immunomodulatory in vitro. The retinoid had no effect on responses to TT as reflected by the characteristics of increased anti-TT IgG levels or the isotype distribution of the antibody. In contrast, the anti-KLH response was significantly enhanced in the 13-cis-RA-treated group. Whereas anti-KLH antibody was detected in only 4 of 13 control subjects after the secondary immunization, 10 of 13 retinoid-treated subjects had measurable levels of anti-KLH IgG (p less than 0.05). Among the responders, no differences were noted in the isotype distribution of anti-KLH antibody. These results showing enhanced anti-KLH responses induced by 13-cis RA therapy represent the first demonstration in humans that in vivo administration of a retinoid can modulate antigen-specific immune responses.

Topics: Acne Vulgaris; Adult; Antibody Formation; Antigens; Dose-Response Relationship, Drug; Enzyme-Linked Immunosorbent Assay; Female; Hemocyanins; Humans; Immunoglobulin G; Male; Tetanus Toxin; Tretinoin

Topics: Acne Vulgaris; Adult; Aluminum Silicates; Clay; Erythromycin; Ethanol; Female; Humans; Male; Salicylates; Tretinoin; Tunisia; Zinc Oxide

20% azelaic acid cream was compared clinically with it vehicle in a 3-month double-blind study of 92 patients with moderate inflammatory acne. In a single-blind study of 289 patients with comedonal acne, the topical azelaic acid preparation was compared with 0.05% tretinoin cream over a period of 6 months. In both controlled studies, 20% azelaic acid cream significantly reduced the number of acne lesions and yielded clinically relevant improvement rates. Azelaic acid cream was significantly and substantially more effective than its vehicle, indicating that the dicarboxylic acid itself is an active drug in acne treatment. In the study of comedonal acne, 20% azelaic acid cream was equally effective as 0.05% tretinoin cream in reducing the number of comedones and with respect to overall response. However, azelaic acid cream was better tolerated, causing fewer local side effects than the topical retinoid.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Child; Clinical Trials as Topic; Dicarboxylic Acids; Double-Blind Method; Drug Eruptions; Erythema; Female; Humans; Male; Middle Aged; Tretinoin

Efficacy and tolerability of a gel preparation with 0.025% tretinoin and 4% erythromycin in acne vulgaris was evaluated in an open multicentre study. A total of 1337 patients of either sex, aged 8 to 68 years, were enrolled in the study; 13 had to be excluded from analysis. Some 499 patients had received former acne treatment; this was described as non-efficient or poorly efficient in 90% of the patients. The treatment period lasted up to 14 weeks. Efficacy was determined by counting the acne lesions (comedones, papules and pustules) before drug administration and every second week during the treatment period. Lesions had diminished after 2 weeks in about 35% of the patients. At the end of the treatment period, comedones were eliminated in 47.0% and improved in another 41.4%. Papules were eliminated and improved in 58.2% and 32.6%, pustules in 74.3% and 18.3% respectively. Side-effects (erythema, burning, pruritus, scaling and dryness of the skin) occurred in 203 patients (15.3%). Treatment was stopped in 25 subjects (1.9%) due to intolerance reactions. The results of the present study thus confirm the high efficacy and tolerability of the fixed combination observed previously in more selected patients. The fixed combination of tretinoin and erythromycin makes retinoic acid treatment possible even by a general practitioner.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Aged; Child; Drug Therapy, Combination; Erythromycin; Family Practice; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Tretinoin

20% azelaic acid cream was compared clinically with its vehicle in a 3-month double-blind study of 92 patients with moderate inflammatory acne. It was found that the azelaic acid treatment significantly reduced inflamed and non-inflamed lesions and yielded clinically relevant improvement rates. Its action was significantly more effective than its vehicle. In the study of comedo acne, 20% azelaic acid cream was equally effective as 0.05% tretinoin cream in reducing the number of comedones and with respect to overall response. However azelaic acid cream was better tolerated, causing fewer local side effects than the tretinoin.

Topics: Acne Vulgaris; Clinical Trials as Topic; Dermatologic Agents; Dicarboxylic Acids; Double-Blind Method; Humans; Ointments; Time Factors; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Clinical Trials as Topic; Drug Evaluation; Humans; Sebum; Tretinoin

In a multicenter study, 788 patients suffering from severe acne resistant to therapy were treated with isotretinoin by 758 dermatologists in private practices. The study was conducted using standardized test forms and questionnaires. The goal of the study was to establish the risk/benefit ratio of the drug, if it was applied to patients of a dermatological practice. The initial daily dose amounted to 0.5 mg/kg body weight, the time of treatment was 12 to 16 weeks. The clinical efficacy was judged very good or good by 90% of the doctors and patients. The kind, frequency, and intensity of the side effects observed corresponded with those found in previous studies conducted at hospitals. Our critical analysis of the results left no doubt about the therapeutic value and the safety of isotretinoin, if it is used by dermatologists in private practices.

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Isotretinoin; Male; Middle Aged; Tretinoin

After 4 hours of exposure to incandescent light, 80% of 0.05% topical isotretinoin and 60% of 0.05% topical tretinoin preparations remained in their original form. In contrast, after 2 hours of exposure to fluorescent light only 25% of topical tretinoin and possibly 60% of topical isotretinoin remained in their original forms. Longer exposure to fluorescent light did not result in further breakdown, and the final breakdown of both preparations was similar. A 12-week, double-blind clinical trial comparing isotretinoin (0.05%) with tretinoin (0.05%) applied topically to patients with moderate acne was carried out. Both preparations caused significant reductions in papules and pustules. However, neither treatment was significantly superior to the other in the reduction of acne lesions. This may be because both preparations are rapidly broken down to similar products when exposed to fluorescent light.

Topics: Acne Vulgaris; Administration, Cutaneous; Chromatography, High Pressure Liquid; Double-Blind Method; Drug Stability; Humans; Isotretinoin; Light; Random Allocation; Tretinoin

The management of skin disease may differ in different parts of the world, but in most countries, acne should be a most treatable disease. Acne therapy has not evolved in the most logical fashion, but this article reviews our demonstration of risk factors in the treatment of acne. Young patients, male patients, truncal acne, a marked seborrhea, and a low dose (500 mg/day or less) of tetracycline are factors associated with a poorer response and, when oral therapy is stopped, a greater relapse rate. One gram a day of tetracycline, given for 6 months, is the minimum course of oral therapy and should be given along with topical therapy. One of the most widely used topical treatments is benzoyl peroxide, and this presentation was given in honor of Dr. William Pace, who was possibly the first dermatologist to be aware of the benefit of benzoyl peroxide--a fact not adequately recorded in dermatologic history. A small number of patients do not respond well to conventional therapy, but alternative treatments should bring about a successful outcome. Alternative treatments include hormonal therapy (i.e., 2 mg cyproterone acetate plus 50 micrograms ethinyl estradiol; spironolactone, 100 mg twice daily; or isotretinoin, 1 mg/kg). The success of all these treatments bears some relationship to their effect in modulating the etiologic factors of acne: an enhanced sebum production, increased ductal cornification, abnormal bacterial colonization, and the production of inflammation. Isotretinoin is the most beneficial of all drug regimens, and this fact no doubt relates to its favorable effect on all etiologic factors.

Topics: Acne Vulgaris; Benzoyl Peroxide; Dose-Response Relationship, Drug; Erythromycin; Female; Humans; Male; Tetracycline; Tretinoin

We evaluated the psychiatric morbidity and mood characteristics of a group (n = 72) of patients with cystic acne before and after treatment with one of three dosage schedules of isotretinoin. Although no excess psychiatric morbidity was observed, substantial evidence of psychologic distress was noted before treatment. Significant reductions in anxiety were observed on several measures of anxiety after treatment, with mitigation of anxiety and depression most robust in those patients with the greatest dermatologic improvement with isotretinoin.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Anxiety; Depression; Female; Humans; Isotretinoin; Male; Psychological Tests; Tretinoin

Two hundred sixty-eight patients with mild to moderate acne vulgaris completed a multicenter, double-blind, controlled study comparing isotretinoin 0.05% gel with its vehicle. Patients were treated twice daily for up to 14 weeks. Efficacy was measured by counting facial inflammatory and noninflammatory lesions and by grading acne severity initially and at 2- to 3-week intervals throughout the study. The isotretinoin 0.05% gel proved to be statistically more effective than vehicle in reducing inflammatory lesions after 5 weeks and in reducing noninflammatory lesions and acne severity grade after 8 weeks. Except for two patients who dropped out because of irritation, isotretinoin 0.05% gel was well tolerated.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Clinical Trials as Topic; Double-Blind Method; Female; Gels; Humans; Isotretinoin; Male; Tretinoin

The drug, 13-cis-retinoic acid, which has been demonstrated to have a marked effect on nodulocystic acne, probably has several mechanisms of action. This article summarizes the effects on the sebaceous glands, and the accompanying changes in cutaneous lipids that result from 13-cis-retinoic acid therapy. These changes in lipid composition support the concept that linoleate may be of importance in the pathogenesis of acne.

Topics: Acne Vulgaris; Animals; Clinical Trials as Topic; Fatty Acids; Humans; Isomerism; Isotretinoin; Linoleic Acid; Linoleic Acids; Lipid Metabolism; Sebaceous Glands; Sebum; Skin; Tretinoin

The number of patients with acne in France is unknown. During a Winter period (October, 1985 to January, 1986), 31 dermatologists in private practice in 5 different regions (Paris, Lyon, Marseille, Rennes and Strasbourg) saw 4,597 cases of acne among 28,714 patients (16.0 p. 100); 293 (6.4 p. 100) of these acne patients had severe acne as defined in the official authorization to launch the drug isotretinoin on the French market: "Nodular and/or cystic acne and severe chronic acne resistant to the main conventional treatments". The patients' mean age was 24.0 +/- 6.7 years, and 66 p. 100 were male (39 p. 100 were students or grammar school pupils); they had the disease for a mean period of 8.2 +/- 5.9 years, and they consulted a dermatologist 4.15 times per annum on average. By extrapolating these figures to the total number of dermatologists practising in France, it could be assumed that in any given year about 17,738 to 19,333 patients with severe acne consulted dermatologists in private practice. Each dermatologist selected at random the record-cards of 4 of his severe acne patients (in all, 121 records) and gave those who came to consult him a letter explaining the purpose of the study and asking them to accept being questioned on the cost and repercussions of their disease. Sixty patients were interrogated by a psychosociologist, 27 accepted to be interrogated every 2 weeks for 2.5 months. The data collected were: i) number of times the patient consulted a general practitioner, a specialist, a surgeon, or a member of the paramedical professions.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Costs and Cost Analysis; Epidemiologic Methods; Female; France; Humans; Isotretinoin; Male; Middle Aged; Random Allocation; Social Behavior; Tretinoin

During a trial of isotretinoin (0.5 mg/kg body weight/day for 3 months) in 90 patients with severe acne, the leucocyte (WBC) count, and particularly the number of neutrophils, decreased significantly. In patients with a good response the mean WBC count fell by 24% and the neutrophils by 33%, whereas in those with a poor response these variables decreased by 8% and 14%, respectively. The serum ALAT, ASAT, cholesterol and triglyceride levels increased significantly. Patients with a poor response (n = 35) received a higher dosage (0.75 mg/kg) for an additional 3 months, and during this period there was a further decrease in the WBC and neutrophil counts and an increase in the triglyceride level. In the other patients, who initially responded well, the dosage was decreased to 0.1 or 0 mg/kg during the second 3-month period, which resulted in reversion of the laboratory variables to the pre-treatment levels. The observed changes were clearly both dose-dependent and reversible.

Topics: Acne Vulgaris; Adolescent; Adult; Alanine Transaminase; Aspartate Aminotransferases; Cholesterol; Clinical Trials as Topic; Dose-Response Relationship, Drug; Female; Humans; Isotretinoin; Leukocyte Count; Male; Tretinoin; Triglycerides

Thirty patients have been treated with either etretin, the main derivative of etretinate, or arotinoid Ro 13-6298, a polyaromatic retinoid, or isotretinoin. Sebum production was measured before and during the treatments. While no change was observed in the patients treated with etretin, a reduction of 33% of the sebum excretion rate was observed for those treated with arotinoid Ro 13-6298 but only after long treatment periods of 20 to 30 weeks. The sebum excretion rate decreased by 92% in the patients treated with isotretinoin. Four patients suffering from severe nodulocystic acne were treated with arotinoid Ro 13-6298 for 2-5 months without improvement. Substantial improvement, however, resulted after a subsequent treatment with isotretinoin; sebum production decreased markedly as well. This study suggests that neither etretin nor arotinoid Ro 13-6298 will replace isotretinoin in the treatment of severe nodulocystic acne.

Topics: Acitretin; Acne Vulgaris; Adult; Aged; Benzoates; Depression, Chemical; Female; Humans; Isotretinoin; Male; Middle Aged; Retinoids; Sebum; Tretinoin

Topics: Acne Vulgaris; Adult; Clinical Trials as Topic; Humans; Isotretinoin; Male; Tretinoin

We have recently reported that patients with severe nodular cystic acne have much lower levels of HDL-cholesterol, apolipoprotein A and hepatic lipoprotein lipase than healthy controls or subjects with acne vulgaris. Since isotretinoin is very effective in the treatment of the nodular cystic acne but has been shown to increase blood lipid levels, we decided to compare its clinical effectiveness and its effects on lipid metabolism with those of minocycline in patients with nodular cystic acne. After 20 weeks, the number and mean diameter of the cysts were definitely decreased in both groups, but the improvement was more striking in the isotretinoin-treated group. At the end of the treatment, the HDL-C and hepatic lipoprotein lipase levels in this group were increased toward normal, but not in the minocycline-treated group. Our study showed a significant remission in the acne of patients treated with isotretinoin but not in that of the minocycline-treated patients. Furthermore isotretinoin can also correct the altered lipid metabolism in these patients.

Topics: Acne Vulgaris; Adult; Cholesterol; Cholesterol, HDL; Humans; Isotretinoin; Lipid Metabolism; Lipoprotein Lipase; Male; Minocycline; Tetracyclines; Tretinoin; Triglycerides

The disposition of oral isotretinoin to the skin and the effects of the drug on the vitamin A levels in serum and skin were studied in 17 patients with nodulocystic acne. All patients received 0.5 mg/kg/day for 3 months and 8 patients continued treatment with 0.75 mg/kg/day for another 3 months. The parent drug, the major metabolite (4-oxo-isotretinoin), and 2 natural retinoids (retinol and dehydroretinol) were monitored in serum and biopsies of uninvolved skin, using adsorption high-pressure liquid chromatography. During the initial 3 months of treatment the mean isotretinoin level in the serum was 145 ng/ml and in the epidermis 73 ng/g. The corresponding values for 4-oxo-isotretinoin were 615 and 113 ng/g, respectively. Even at the highest dosage there was no progressive accumulation of isotretinoin in serum, epidermis, or subcutis. After discontinuation of therapy the drug disappeared from both serum and skin within 2-4 weeks. The serum transport of vitamin A, monitored by the concentrations of retinol, retinol-binding protein, and prealbumin (transthyretin), was not affected by the treatment. By contrast, the retinol level in the epidermis increased by an average of 53% (p less than 0.01) and the dehydroretinol level decreased by 79% (p less than 0.001) as a result of 3 months of treatment. Both changes were reversible. The results suggest that isotretinoin therapy interferes with the endogenous vitamin A metabolism in the skin.

Topics: Acne Vulgaris; Adult; Biological Transport, Active; Clinical Trials as Topic; Female; Humans; Isomerism; Isotretinoin; Male; Skin; Tretinoin; Vitamin A

It is clear that tretinoin has a major place in the treatment of acne via its effect on the abnormal pattern of keratinization, the initial pathophysiologic event in the disease. However, for purposes of introduction, it is useful to compare tretinoin with another topical retinoid, motretinide (Ro 11-1430), which is currently used in Europe. Herein is an overview of several studies that have examined the efficacy of these two agents.

Topics: Acne Vulgaris; Administration, Topical; Clinical Trials as Topic; Double-Blind Method; Humans; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Adult; Clinical Trials as Topic; Double-Blind Method; Humans; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Female; Humans; Isotretinoin; Lipid Metabolism; Male; Middle Aged; Skin; Tretinoin

Topics: Acne Vulgaris; Adult; Clinical Trials as Topic; Female; Humans; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Clinical Trials as Topic; Female; Humans; Isotretinoin; Sebum; Tretinoin

Isotretinoin (Accutane) is a lately developed synthetic oral retinoid for treatment of severe forms of cystic acne resistant to therapy. Its pharmacological effect principally consists in decreased size of the sebaceous glands, reduced sebum production, as well as alteration of the bacterial micropopulation. At a dosage of 0.5 mg up to 1.0 mg/kg body weight daily, isotretinoin led to significant reduction of the inflammatory skin eruptions and long-lasting remission after discontinuation of the drug. With regard to 18 patients suffering from rosacea, the application of Accutane brought about satisfactory results, as well. Mucocutaneous side-effects were almost compulsory, but did never lead to discontinuation of the treatment. Because of its teratogenity, isotretinoin must not be applied in case of gravidity. Accutane offers new modes of therapy with respect to patients suffering from nodulocystic acne or severe rosacea which did not respond to common forms of treatment.

Topics: Acne Vulgaris; Adolescent; Aged; Clinical Trials as Topic; Etretinate; Female; Humans; Isotretinoin; Male; Middle Aged; Rosacea; Tablets; Tretinoin

Thirty patients with treatment-resistant cystic and conglobulate acne entered a randomized double-blind protocol, testing the efficacy of isotretinoin versus tetracycline. After 16 weeks of isotretinoin treatment, the mean number of cysts decreased by 64% and the mean sum of the longest diameters was reduced by 68%. After 16 weeks of tetracycline therapy, the total number of cysts showed a mean decrease of 52%, and the mean sum of the longest diameters decreased by 60%. The reduction in the number of cysts and the sum of their longest diameters that occurred after 16 weeks of treatment was statistically significant for each of the treatment groups, but there was no statistically significant difference between the treatment groups at the end of therapy. Eight weeks after the discontinuation of treatment in the isotretinoin group, there was an overall reduction from baseline of 82% in the cyst count and 88% in the sum of the longest diameters. In the tetracycline treatment group, the overall reduction from baseline in the cyst count was 54% and in the sum of the longest diameters, 60%. This led to a statistically significant difference in the two treatment groups at 24 weeks. All patients on isotretinoin experienced side effects that were primarily related to the integumentary system but necessitated discontinuation of the drug for a short period of time in only one patient. Long-term follow-up, 8 months after discontinuation of the study, showed a prolonged significant remission of acne in the isotretinoin group but not in the tetracycline group.

Topics: Acne Vulgaris; Adolescent; Adult; Cataract; Cheilitis; Clinical Trials as Topic; Double-Blind Method; Epistaxis; Female; Follow-Up Studies; Humans; Isomerism; Isotretinoin; Male; Random Allocation; Tetracycline; Tretinoin; Xerophthalmia; Xerostomia

The contribution of the keratinizing epidermis to the human skin surface lipid film has been difficult to ascertain because, after its release from the epidermal cells, epidermally derived lipid inevitably becomes mixed with sebum. In the present study, the sustainable rates of production of the 5 neutral lipid classes found on the skin surface (triglycerides + free fatty acids, wax esters, cholesterol, cholesterol esters, and squalene) were measured on the foreheads of acne patients before, during, and following treatment with 13-cis-retinoic acid, a drug which suppresses sebum production profoundly. Since sebum production was high in the patients before treatment and was suppressed to a few percent of the pretreatment level in some of the patients during treatment, data covering a wide range of sebum production rates were obtained. By using squalene as a measure of sebum production and plotting the rates of production of the other lipid classes vs the rate of production of squalene, it was possible through extrapolation to estimate the residual (i.e., epidermal) rate of production of each lipid class at zero sebum production. The results indicated that epidermis releases triglycerides + free fatty acids and cholesterol to the skin surface. The cholesterol esters in freshly secreted skin surface lipids appeared to be almost entirely sebaceous in origin. Measurements were also made of the percentages of cholesterol esters in lipid collected from the scalp after several days' accumulation and were compared to corresponding values for the forehead lipid. The percentages of cholesterol esters in scalp lipid tended to rise when sebum production was suppressed by the drug, rather than remaining relatively constant as occurred in the freshly secreted forehead lipid. This result indicated that epidermis may contribute to skin surface cholesterol esters, probably through skin surface esterification of epidermal cholesterol.

Topics: Acne Vulgaris; Adolescent; Adult; Cholesterol; Cholesterol Esters; Clinical Trials as Topic; Fatty Acids, Nonesterified; Female; Forehead; Humans; Isotretinoin; Lipids; Male; Scalp; Sebum; Skin; Squalene; Tretinoin; Triglycerides

30 patients with acne vulgaris were treated topically with motretinide 0.1% vanishing cream or benzoyl peroxide 5% gel in an open study. Good results were obtained in both groups. Benzoyl peroxide caused local irritation in 73% of the patients, whereas motretinide was well tolerated except in 1 case. Motretinide is considered an alternative in the treatment of papulopustular acne in young adults.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide; Drug Evaluation; Humans; Peroxides; Tretinoin

One hundred fifty patients with treatment-resistant nodulocystic acne were entered into a double-blind clinical study. Three different dosing levels (0.1, 0.5, 1.0 mg/kg/day) were used in equal-sized groups. In addition to the clinical response, the clinical side effects, the laboratory abnormalities, and the duration of the induced remissions were evaluated with each dose of the drug. There was a highly significant clinical response to treatment with all three dosages of isotretinoin. There was no significant difference in the clinical response between dosages. However, 42% of the patients who received 0.1 mg/kg/day of isotretinoin required retreatment with the drug. This finding, coupled with only minor differences in the clinical side effects and the laboratory abnormalities, indicates that higher dose levels of isotretinoin are indicated for treatment of nodulocystic acne.

Topics: Acne Vulgaris; Adult; Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Isotretinoin; Lipids; Liver; Male; Tretinoin

Twenty-seven males with severe acne were treated for 12 weeks with 0.05 mg/kg/day isotretinoin (ten patients) or 5 mg daily cyproterone acetate (eight patients) or both drugs together in these doses (nine patients). With isotretinoin, the sebum excretion rate (SER) fell by 45% +/- 9% s.e.m. (P less than 0.0025), lesion count fell by 65% +/- 10% (P less than 0.0005) and median clinical 17% +/- 12% (NS) fall in SER, a 15% +/- 10% (NS) fall in lesion count and the median severity was unchanged. Patients unchanged. Patients treated with both drugs showed a 42% +/- 13% reduction in SER (P less than 0.005), a 68% +/- 11% decrease in lesion count (P less than 0.0005) and a decrease in median severity from 8 to 4 (P less than 0.01) which was no different from the response to isotretinoin alone. Isotretinoin increased serum cholesterol from 4.4 mmol/l +/- 0.3 s.e.m. to 4.7 mmol/l +/- 0.3 s.e.m. (P less than 0.01), serum triglyceride from 0.73 mmol/l +/- 0.07 s.e.m. to 0.96 mmol/l +/- 0.14 s.e.m. (P less than 0.05) and gamma-glutamyltransferase (GGT) from 15.9 i.u./l +/- 2.1 s.e.m. to 19.0 i.u./l +/- 2.4 s.e.m. (P less than 0.01). Comparison of the area under the concentration-time curve for triglyceride and high density lipoprotein (HDL)-cholesterol showed that the changes were smaller when isotretinoin was combined with cyproterone acetate. We conclude that the effect of isotretinoin in acne was not enhanced by the antiandrogen, but the increase in serum triglyceride and decrease in HDL-cholesterol produced by the retinoid were reduced by combination with the antiandrogen.

Topics: Acne Vulgaris; Adolescent; Adult; Cyproterone; Cyproterone Acetate; Drug Therapy, Combination; Humans; Isotretinoin; Male; Sebum; Secretory Rate; Tretinoin

Topics: Acne Vulgaris; Clinical Trials as Topic; Humans; Kinetics; Tretinoin

The clinical efficacy and tolerance of a combination of benzoyl peroxide 5% and miconazole 2%, Acnidazil, for the treatment of facial acne vulgaris have been compared with those of tretinoin 0.05% in a double-blind study with 40 patients during 12 weeks. The combination of benzoyl peroxide and miconazole gave improvement in 82% of 22 patients, compared to tretinoin which gave improvement in 50% of 18 comparable patients. The difference is significant. Also, side-effects were significantly less in the benzoyl-miconazole group than in the tretinoin group.

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Humans; Male; Miconazole; Peroxides; Tretinoin

A follow-up was done on the patients of the German multicenter study with severe conglobate acne who had been treated with different dosages of 13-cis-retinoic acid. Eighty-seven patients were monitored from 12 to 21 months. Optimal long-term therapeutic effects were obtained with an initial dose of 1.0 mg/kg body weight, for 3 months, followed by another 3-month-treatment period with 0.2 mg/kg body weight. Six months after the termination of therapy 96% of the patients were still in remission and 81% after 12 months. Comparative figures for the administration of doses were 84% as opposed to 47% (0.5----0.2 mg/kg body wt.) and 74% as opposed to 37% (0.2----0.2 mg/kg body wt.), respectively. It is suggested from the present data that a high initial dosage of 13-cis-retinoic acid be chosen in order to obtain optimal long-term therapeutic effects. Transiently elevated lipid levels as well as other tolerable side effects return to normal within 3 months at the latest after discontinuation of treatment.

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Dermatitis, Seborrheic; Follow-Up Studies; Humans; Isomerism; Isotretinoin; Mucous Membrane; Recurrence; Skin; Time Factors; Tretinoin; Xerostomia

Successful treatment of acne conglobata with 13-cis-retinoic acid (isotretinoin, Ro 4-3780) has already been reported in this journal [25, 36]. The aim of the present study was to treat severe forms of papulopustular acne, unresponsive to conventional therapy, with low doses of 13-cis-retinoic acid to obtain good results with few side effects. A total of 191 patients from 14 departments of dermatology in the Federal Republic of Germany received 13-cis-retinoic acid under open randomized conditions in parallel dose groups of 0.05, 0.1, and 0.2 mg/kg body weight for 20 weeks in order to establish efficacy and tolerance. All inflammatory and non-inflammatory skin lesions were counted. The intensity of seborrhea was graded by using a scale. Adverse effects as well as laboratory values were registered. After 20 weeks of treatment a 79% (0.05 mg), 80% (0.1 mg), and 84% (0.2 mg) decrease in the number of inflammatory skin lesions was seen. Fourteen patients in the lowest dose group were considered to be dropouts. The decrease in non-inflammatory skin lesions was less marked and amounted to between 49% and 69%. A significant reduction of seborrhea could be observed in all patients. The main side effect was dryness of the skin and mucous membranes, which was, however, of low intensity. The elevation of triglyceride and cholesterol levels reported with higher doses of 13-cis-acid, especially in patients with high-risk factors, were not encountered in this study.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Clinical Trials as Topic; Dermatitis, Seborrheic; Dose-Response Relationship, Drug; Female; Humans; Isotretinoin; Male; Tretinoin

Comedolytic activity was assessed in acne patients by determining the reduction in facial microcomedones using the cyanoacrylate follicular biopsy technique. Microcomedones were counted in five-em squares after 8 to 12 weeks of treatment. Only salicylic acid and tretinoin among seven conventional anti-acne medications were found to possess comedolytic activity. The latter was the more effective.

Topics: Acne Vulgaris; Biopsy; Cyanoacrylates; Female; Hair; Humans; Male; Salicylates; Tretinoin

Topics: Acne Vulgaris; Clinical Trials as Topic; Humans; Isomerism; Isotretinoin; Tretinoin

13-cis-retinoic acid has been used as a single agent in the treatment of seventy-six patients with previously unresponsive cystonodular acne. The study was carried out in a double-blind fashion using three doses of the drug. Ninety per cent of the patients responded with a 70% improvement in the acne severity. Sixty-six per cent of the patients experienced no further problems with their acne during follow-up. Side-effects were frequent. The 0.5 mg/kg b.w. dose is recommended for the initial course of treatment.

Topics: Acne Vulgaris; Adult; Aspartate Aminotransferases; Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Isotretinoin; Lipids; Male; Sebum; Time Factors; Tretinoin

Changes in sustainable rates of sebum secretion were followed in twenty patients with severe acne who were receiving oral treatment with 13-cis-retinoic acid in dosages of 0.1, 0.5, or 1.0 mg/kg/day. Sebum secretion was measured by absorption of skin surface lipid into bentonite clay and estimation of the amount of absorbed sebum by measurement of its wax ester component. Pretreatment rates of sebum secretion in the patients were greatly elevated in comparison with previously measured values in young adult subjects without acne. After 4 weeks of treatment, mean rates of sebum secretion on all three dose levels fell to or below the range for normal subjects. On-treatment rates of sebum secretion were significantly lower in patients on the highest dose compared to patients on the lowest dose. When the drug was discontinued, rates of sebum secretion recovered slowly. Clinical response was excellent in most of the subjects. The five subjects with least favorable response clinically all had better than average suppression of sebum production.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Female; Humans; Isotretinoin; Male; Sebum; Secretory Rate; Tretinoin

Topics: Acne Vulgaris; Clinical Trials as Topic; Cysts; Double-Blind Method; Humans; Isotretinoin; Male; Tretinoin

Isotretinoin, an isomer of retinoic acid, recently has been approved by the Food and Drug Administration for treatment of severe, recalcitrant acne. The most impressive effects include inhibition of sebum production and a reversible decrease in sebaceous gland size. Isotretinoin has proved to be an effective drug; response to therapy has been seen in virtually 100 percent of patients treated. Almost all patients experience reversible cutaneous and mucous-membrane symptoms while on isotretinoin treatment. Other common side effects include conjunctivitis (38 percent) and eye irritation (50 percent). The recommended dosage is 1-2 mg/kg/d for no longer than 16 weeks. Isotretinoin is currently the treatment of choice for severe, recalcitrant acne; however, because of potential side effects associated with retinoids, isotretinoin should be reserved for those patients who are unresponsive to conventional therapy, including topical and systemic antibiotics.

Topics: Acne Vulgaris; Clinical Trials as Topic; Eye; Humans; Intestinal Absorption; Isotretinoin; Sebum; Tissue Distribution; Tretinoin; Triglycerides

Three male patients with severe nodulocystic acne were treated with oral isotretinoin in a dosage of 0.5 to 1.0 mg/kg/day. A flare of their disease developed, characterized by an inflammatory, hemorrhagic, pyogenic, granuloma-like response of previously crusted acne lesions. This reaction occurred between the sixth and ninth weeks of treatment and was confined entirely to the chest and back. The severity of the reaction prompted the administration of oral prednisone and, in two cases, the discontinuation of isotretinoin therapy. In one patient, pyoderma gangrenosum developed on the thigh. The exact incidence of this pyogenic, granuloma-like reaction to isotretinoin is unknown, although we have seen it in three of 66 patients with nodulocystic acne treated with this drug. The cause of the reaction is unknown, but it may be due to the increased skin fragility and vascular proliferation known to be induced by isotretinoin.

Topics: Acne Vulgaris; Administration, Oral; Adult; Double-Blind Method; Drug Eruptions; Granuloma; Hemorrhage; Humans; Isotretinoin; Male; Pyoderma; Skin Ulcer; Tretinoin

Results of the isotretinoin (13-cis-retinoic acid, Ro 4-3780) German Cooperative Study Group, with 198 acne conglobata patients being treated in 19 departments are reported. For the first 12 weeks (phase I) there was an open assignment to 0.2, 0.5 or 1.0 mg/kilogram bodyweight (kg bw). This was followed by further 12 weeks (phase II). If there was at least a two-third improvement of lesions, the 0.2 mg/kg bw was continued, and the 0.5 mg/kg bw dose lowered to 0.2 mg/kg bw. If there was no such improvement, the dose was elevated to 0.5 and 1.0 mg/kg bw respectively. The initial high dose group of 1.0 mg/kg bw was divided after twelve weeks into 0.2 mg/kg bw maintenance therapy, or no therapy at all. Non-inflammatory and inflammatory acne lesions from the entire body were counted. Seborrhea was graded on a four scale (0 to 3+). Subjective side effects were registered. Laboratory data included hematological profile with differential counts, creatinin, SGOT, SGPT, alkaline phosphatase, total bilirubin, serum cholesterol and serum triglycerides, and urine analysis. For statistical analysis 171 patients were available, 27 dropped out of the study, mostly for reasons unrelated to the drug. At least 75 per cent improvement was seen, in the 0.2 mg/kg bw group in 73.7 and 59.5 per cent respectively; in the 0.5 mg/kg bw group in 72.5 and 61.2 per cent respectively; and in the 1.0 mg/kg bw group in 85.4 and 92 per cent respectively (phase I t12 and phase II t24 values, respectively). Sebum suppression was dose-related. Subjective side effects were fairly well dose-related, particularly those of skin and mucous membranes. Myalgia was rare. There was a dose-related elevation of triglycerides and cholesterol, but not significant for the means of each group. Single patients did show significant elevation of blood lipids. All other laboratory parameters did not change significantly. Isotretinoin is presently the most effective drug to control severe forms of acne, leading to long lasting remissions.

Topics: Acne Vulgaris; Administration, Oral; Clinical Trials as Topic; Dermatitis, Seborrheic; Female; Germany, West; Humans; Isotretinoin; Male; Time Factors; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Drug Evaluation; Humans; Isotretinoin; Male; Random Allocation; Tretinoin

Twenty men with nodulocystic acne were treated with oral isotretinoin (13-cis-retinoic acid) for four months. Plasma lipids and lipoprotein determinations were obtained before and during treatment to quantitate the effects of oral isotretinoin on lipid metabolism. Maximum isotretinoin-induced elevations in plasma triglyceride and cholesterol levels were 67% and 16%, respectively. Additional maximal changes included very-low-density lipoprotein cholesterol increases of 56%, low-density lipoprotein cholesterol increases of 22%, and high-density lipoprotein decreases of 10% from pretreatment values. Chronic increases in plasma cholesterol levels, increases in low-density lipoprotein cholesterol levels, and decreases in high-density lipoprotein cholesterol levels may predispose subjects to premature atherosclerosis. Because of the potential for unmasking an occult lipid or lipoprotein disorder, the plasma lipid and lipoprotein profiles of subjects receiving isotretinoin should be carefully monitored.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Cholesterol, VLDL; Humans; Isotretinoin; Lipoproteins, HDL; Lipoproteins, LDL; Lipoproteins, VLDL; Male; Prospective Studies; Tretinoin; Triglycerides

58 male patients with therapy-resistant conglobate acne were randomly selected for treatment with isotretinoin 1.0 or 0.5 mg/kg bodyweight. 27 patients received the high-dose regimen and 31 patients the lower dosage. The efficacy of the drug was highly satisfactory in both therapy groups and no differences could be observed between them. Side-effects (dry lips, dry nose, scaling of the skin) were generally well tolerated in both groups, they were more serious in the 1.0-mg/kg group. It is concluded that isotretinoin therapy is very effective in male patients with conglobate acne and that a dosage of 0.5 mg/kg is preferable to higher dosage regimens.

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Dose-Response Relationship, Drug; Humans; Isotretinoin; Male; Random Allocation; Seasons; Tretinoin; Triglycerides

Orally administered retinoids are synthetic derivatives of vitamin A. This new group of drugs (not yet available for general use in the United States) has been effective in experimental trials for treatment of a wide range of skin diseases. The current status of two of these drugs, isotretinoin (13-cis-retinoic acid) and etretinate (Ro 10-9359), is herein reviewed.

Topics: Acne Vulgaris; Administration, Oral; Child; Clinical Trials as Topic; Facial Dermatoses; Female; Humans; Isomerism; Isotretinoin; Keratins; Keratitis; Neoplasms; Psoriasis; Skin Diseases; Tretinoin; Xerostomia

Forty-eight acne patients were treated orally with 13-cis-retinoic acid in a double-blind dose response study. There was a marked clinical improvement with a concomitant reduction in sebum excretion rate (SER) and production rate of free fatty acids (FFA). Microbial numbers decreased significantly; the decrease in propionibacteria was greater than that of aerobic bacteria. The decline in micro-organisms occurred after the reduction in sebum and FFA production. This suggests that the effect of the drug upon micro-organisms is secondary to the change in sebum excretion but it is nevertheless an important factor in the resolution of the acne.

Topics: Acne Vulgaris; Adult; Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Fatty Acids, Nonesterified; Female; Humans; Isotretinoin; Male; Sebum; Skin; Tretinoin

Thirty-three patients with treatment-resistant cystic and conglobate acne entered a randomized, double-blind protocol testing the efficacy of isotretinoin versus placebo. There was an overall 57% increase in the number of cystic lesions in seventeen patients who initially received placebo. Sixteen of these seventeen patients then received isotretinoin, with a resultant 98% improvement. The sixteen patients who had been randomly assigned to receive initial therapy with isotretinoin had a 95% improvement. Twenty-seven of the thirty-two patients treated with isotretinoin cleared completely. The average maximum dosage of isotretinoin received by these patients was 1.2 mg/kg/day. Eighteen patients received only one 4-month course of isotretinoin. Fifteen patients received two courses. These included twelve patients with predominantly truncal acne who responded partially to the first course, and three patients who had cleared completely after one course of therapy but had mild relapses after an average of six months off of treatment. All patients are now in remission averaging 38 months in duration. Skin biopsies and quantitative measurement of sebum production during therapy indicated a profound inhibition of sebaceous gland size and function, which may be central to the mechanism of action of isotretinoin in acne.

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Isomerism; Isotretinoin; Male; Sebum; Tretinoin

Sebum production has been measured in twenty patients in whom 13-cis-retinoic acid therapy had been discontinued for at least 20 weeks. While sebum production had returned to pretreatment levels by 30 weeks in seven subjects, 30% to 80% reduction in sebaceous gland activity was still present for as long as 80 weeks in eight subjects. Four of these eight patients, who were followed for more than a year, still had marked sebaceous inhibition when last tested. The prolonged remission seen in patients with nodulocystic acne may be related in part to continued sebaceous gland inhibition in some patients, but it obviously is not the only actor responsible for the long-term improvement that is seen.

Topics: Acne Vulgaris; Clinical Trials as Topic; Double-Blind Method; Humans; Isomerism; Isotretinoin; Sebum; Tretinoin

Isotretinoin (13-cis-retinoic acid) was compared with the aromatic retinoid, etretinate, in patients with severe nodulocystic acne. Evaluation of fifty-six such men receiving 1 mg/kg of one or the other of these two drugs was performed with regard to clinical improvement and change in sebum production. Lesion counting demonstrated a significant improvement in patients receiving isotretinoin, particularly in facial lesions. There was significantly less improvement with etretinate. Similarly, isotretinoin produced a marked suppression of sebum production. There was little effect of etretinate on sebum production. Side effects were limited primarily to the skin and mucous membranes.

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Double-Blind Method; Etretinate; Humans; Isomerism; Isotretinoin; Male; Middle Aged; Sebaceous Glands; Sebum; Tretinoin

Good to excellent clinical results have been obtained in the treatment of severe inflammatory acne (acne conglobata, acne fulminans, and acne conglobata with hidradenitis and dissecting cellulitis of the scalp) with orally administered isotretinoin (13-cis-retinoic acid). Similar promising results have been obtained in patients with severe rosacea and gram-negative folliculitis. Isotretinoin probably has multiple modes of action, including (1) inhibition of sebaceous gland activity, (2) inhibition of the growth of Propionibacterium acnes within the follicle, although the retinoid is not antibacterial, (3) inhibition of inflammation, and (4) alteration of the pattern of keratinization within the follicle, as demonstrated by light and ultrastructural studies.

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Enterobacteriaceae Infections; Female; Folliculitis; Humans; Isomerism; Isotretinoin; Male; Rosacea; Skin; Tretinoin

The clinical efficacy and tolerance of a new retinoic acid derivative, Ro 11-1430, in the treatment of acne vulgaris have been compared with those of tretinoin in a double-blind trial with 60 patients during 8 weeks. The efficacy of both drugs was good. Tretinoin showed a tendency to give better effect but this was not statistically significant. However, tolerance of the new derivative was better. 48 of the patients were treated with Ro 11-1430 for another 3 months with good effect and tolerance. In a long-term study, 32 patients with previous irritation of tretinoin have been treated with Ro 11-1430 between 1.5 and 17 months with good tolerance.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Chemical Phenomena; Chemistry; Child; Clinical Trials as Topic; Double-Blind Method; Drug Tolerance; Female; Humans; Male; Tretinoin

Patients with very severe acne which had not responded to conventional treatment were given 13-cis retinoic acid (0.1 mg-1.0 mg/kg body-weight) in a double-blind dose response study. Sebum excretion rate was reduced by 75% at 4 weeks, and all patients had an 80% improvement in their acne severity after 4 months treatment. There were dose-related side-effects, particularly dryness of the skin and mucous membranes. No patient wished to stop treatment.

Topics: Acne Vulgaris; Adolescent; Adult; Dose-Response Relationship, Drug; Humans; Isotretinoin; Sebum; Secretory Rate; Tretinoin

The mode of action of benzoyl peroxide in acne is three-fold, i.e. sebostatic, comedolytic and inhibitory to P. acnes in-vivo. Benzoyl peroxide is the topical treatment of choice in acne vulgaris. This agent is well tolerated by most patients. Primary irritant dermatitis can be avoided by less frequent application and the true incidence of contact sensitivity is low. The gel preparation has achieved a high degree of cosmetic acceptability. A synergistic effect with retinoic acid can be demonstrated. Tolerance to benzoyl peroxide develops in most subjects necessitating more vigorous therapy, usually after two or three weeks of treatment. Many acne sufferers with mild or moderate disease can avoid long-term oral antibiotic treatment by the judicious use of benzoyl peroxide topically.

Topics: Acne Vulgaris; Benzoyl Peroxide; Clinical Trials as Topic; Drug Combinations; Humans; Keratins; Peroxides; Propionibacterium acnes; Sebaceous Glands; Tretinoin

Sebum production and skin surface lipid composition have been measured during the oral treatment with 13cis-retinoic acid of a group of patients with severe cystic acne. Two hundred and thirty-eight paired samples have been analyzed and compared. A marked, drug-induced decrease in sebum production was accompanied by a decrease in the concentration of wax esters, a slight decrease in the squalene concentration and in increase in the cholesterol concentration in the skin surface lipids. These changes were consonant with changes in the relative contributions of sebum and epidermal lipid to the surface film, except that at very low levels of sebum production there might be preferential preservation of squalene synthesis.

Topics: Acne Vulgaris; Adult; Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Humans; Lipids; Sebaceous Glands; Sebum; Tretinoin

The comparative effectiveness of three comprehensive therapeutic programs was studied in 118 patients with mild to moderate acne vulgaris. A topical program of tretinoin, benzoyl peroxide, and water avoidance was found to be as effective as the more commonly employed program of systemic tetracycline therapy with topically applied tretinoin and better than a program using systemic tetracycline therapy with abradant cleansers. At 16 weeks of therapy for all groups, the degree of skin dryness correlated with lack of improvement. Skin dryness is established as an aggravating factor in both the pathogenesis and treatment of acne. The topical program was nonirritating, well accepted by patients, and less expensive than the other two regimens.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide; Climate; Clinical Trials as Topic; Female; Follow-Up Studies; Humans; Humidity; Male; Peroxides; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Erythromycin; Female; Humans; Male; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Age Factors; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Isotretinoin; Sebum; Sunlight; Tretinoin

Fourteen patients with severe, treatment-resistant, nodulocystic acne have been treated with 13-cis-retinoic acid in a double-blind study. The patients were treated with either 0.1, 0.5, or 1.0 mg/kg/day of 13-cis-retinoic acid for 12 weeks. A marked dose-related decrease in sebum production, which was usually evident within 2 weeks of the onset of therapy, was observed in all patients. At a dose of 1.0 mg/kg/day of 13-cis-retinoic acid, sebum production was decreased to about 10% of the pretreatment value. Clinical improvement, as judged by counting the nodulocystic lesions and measuring their greatest diameters, was noted in all three groups. The most common clinical side effects were cheilitis, desquamation of the skin, and pruritus, but the side effects were not severe enough to require interruption of treatment. Laboratory abnormalities during therapy were minimal and also did not necessitate the cessation of therapy.

Topics: Acne Vulgaris; Adolescent; Adult; Double-Blind Method; Humans; Isotretinoin; Lipids; Male; Sebum; Skin; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Clinical Trials as Topic; Humans; Isomerism; Tretinoin; Vitamin A

In a parallel group comparison of a 5% benzoyl peroxide gel with a 0.05% retinoic acid cream, in moderate facial acne vulgaris, significantly more patients in the benzoyl peroxide group experienced overall excellent results than did those in the other group. Both medications, however, were effective in reducing the numbers of both inflammatory and noninflammatory lesions. The benzoyl peroxide gel appeared to produce a more rapid effect on inflammatory lesions than did retinoic acid, and produced significantly less peeling.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide; Clinical Trials as Topic; Humans; Peroxides; Time Factors; Tretinoin; Vitamin A

In a double-blind randomized comparative multicenter trial, consisting of 29 patients with acne vulgaris who were unable to tolerate daily applications of retinoic acid, the retinoic acid derivative Ro 11--1430 (0.1% vanishing cream) was compared in a 6--8 weeks topical treatment with vanishing cream alone (placebo). Regarding efficacy, for most criteria measured the response was always better with Ro 11--1430 than with placebo, although the differences were not always statistically significant for several reasons, one probably being the small number of patients in the trial. Regarding tolerance, both treatments were satisfactory. Ro 11---1430 and placebo did not differ significantly regarding frequency and severity of erythema, desquamation and burning. These results suggest that treatment with Ro 11--1430 should be considered in acne patients who are unable to use retinoic acid due to severe local reactions.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Clinical Trials as Topic; Double-Blind Method; Drug Hypersensitivity; Female; Humans; Male; Placebos; Random Allocation; Tretinoin

A twice daily application of 2% erythromycin base in hydroalcoholic solution accompanied by once daily use of 0.05% tretinoin (retinoic acid) solution was substantially more effective than tretinoin or erythromycin alone for treatment of inflammatory acne of moderate severity. Therapeutic enhancement by this combination can be attributed to the different modes of action, erythromycin acting chiefly by suppressing Propionibacterium acnes, while tretinoin is comedolytic. In addition, by altering the horny layer barrier, tretinoin doubtless increases the penetration of erythromycin.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Clinical Trials as Topic; Drug Evaluation; Drug Therapy, Combination; Erythromycin; Female; Humans; Male; Tretinoin; Vitamin A

A controlled, randomized clinical study comparing different commercially available benzoly peroxide gels and tretinoin cream was undertaken by four investigators using similar protocols and case report forms. Results were based on lesion-count reduction over an 8-week period. No significant difference in reduction of total acne lesions was detected between the benzoyl peroxide gels and tretinoin cream. However, benzoyl peroxide was significantly better (P less than .02) in reduction of papules and as good as tretinoin in reduction of comedones. Results of this study suggest that excessive drying and peeling are not essential in the reduction of acne lesions.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide; Child; Female; Humans; Male; Peroxides; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Adolescent; Adult; Clinical Trials as Topic; Double-Blind Method; Female; Gels; Humans; Male; Tetracycline; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Allantoin; Anti-Inflammatory Agents; Chloramphenicol; Clinical Trials as Topic; Dermatologic Agents; Drug Combinations; Female; Humans; Hydrocortisone; Male; Random Allocation; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Aged; Clinical Trials as Topic; Drug Evaluation; Female; Gels; Humans; Male; Middle Aged; Ointments; Rosacea; Solutions; Tretinoin; Vitamin A

The topical effect on acne of a benzoyl peroxide acetone gel was studied over an eight week period and simultaneously compared with the effect of a benzoyl peroxide lotion and a vitamin A acid cream. The three formulations produced a significant reduction in the number of comedones. The two benzoyl peroxide formulations substantially reduced the number of papules, but this effect was not observed to a significant degree with the vitamin A acid. Burning sensation following application, a common problem with the benzoyl peroxide alcohol gels, was not reported by patients using the benzoyl peroxide acetone gel.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide; Female; Gels; Humans; Male; Peroxides; Tretinoin

In a double-blind controlled multicenter trial consisting of 257 patients with acne vulgaris an 8-week topical treatment with the retinoic acid derivative Ro 11-1430 (0.1% lotion) was compared with vitamin A acid (0.05% lotion) and the lotion alone (placebo). In reducing the number of comedones vitamin A acid was superior to Ro 11-1430, which was significantly better than placebo. The reduction in number of papules and pustules was not statistically significant on either treatment. Local side effects, i.e. erythema, desquamation, burning and pruritus occurred more frequently and were more severe on vitamin A acid than on Ro 11-1430 and placebo which did not differ. No correlation was found between incidence and severity of local reactions and therapeutic effect.

Topics: Acne Vulgaris; Administration, Topical; Clinical Trials as Topic; Drug Eruptions; Drug Evaluation; Erythema; Humans; Pruritus; Tretinoin; Vitamin A

Neutrogena hand cream has been used to modify the erythema, dryness, and topical irritancy caused by topical tretinoin and other topical acne preparations in a study of fifty-two patients.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Erythema; Female; Humans; Male; Ointments; Tretinoin; Vitamin A

A clinical trial on the aromatic ethylamide derivative of retinoic acid (Ro. 11-1430) applied topically was carried out for 10 weeks on 50 ambulatory patients suffering from various degrees of acne vulgaris. This clinical trial assessed the efficacy and side reactions of Ro. 11-1430 in the treatment of acne vulgaris, especially when used in the tropics. A comparison was made between the results obtained in this trial and those in another trial using topical retinoic acid. Analysis made in terms of efficacy, drug tolerance, patients' complaints and duration of treatment for achieving obvious alleviation of symptoms shows that Ro. 11-1430, with the exception of side reactions due to the drugs applied, was inferior to retinoic acid. Relapses as well as remissions often occurred during the period of maintenance therapy. Like retinoic acid, Ro. 11-1430 has a palliative effect only and not a curative one.

Topics: Acne Vulgaris; Adolescent; Child; Female; Humans; Male; Time Factors; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Child; Female; Humans; Male; Tretinoin

In patients with facial acne good results were obtained by topical treatment with a 0-05 per cent solution of retinoic-acid (tretinoin) solution and with a 0-025 per cent solution. The improvement was judged by clinical assessment and by counts of comedones, papules and pustules before and after the 12-week trial. Side-effects such as irritation and erythema were less with the 0-025 per cent solution. The use of swabs impregnated with a constant volume of solution and sealed in a sachet proved to be a convenient method of application. In the placebo group, swabs impregnated with the solvent only showed virtually no effect on facial acne.

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Female; Humans; Male; Time Factors; Tretinoin; Vitamin A

A controlled non-blind multicenter trial was conducted in 211 acne patients to test the activity of topical retinoic acid against sulfur-resorcinol--salicylic acid and placebo. Uniform evaluation criteria were used. After 8 weeks' treatment in comparable groups of patients, retinoic acid proved to be superior to the standard and to the placebo. The difference was statistically significant. Side effects were present in a number of patients treated with the active substances and with the placebo (mainly erythema), but rarely was the treatment discontinued.

Topics: Acne Vulgaris; Adolescent; Adult; Clinical Trials as Topic; Female; Humans; Male; Placebos; Resorcinols; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide; Child; Clinical Trials as Topic; Drug Therapy, Combination; Female; Humans; Male; Peroxides; Tretinoin; Vitamin A

In a double-blind, randomized, group-comparative clinical trial, 31 patients with acne vulgaris received topical treatment for 6-8 weeks with a lotion containing either 0.05% retinoic acid or 0.1% of the retinoic acid derivative Ro 11-1430. The side-effects erythema, desquamation and burning were significantly less frequent with Ro 11-1430 than with retinoic acid. The treatments appeared to be approximately equally effective in reducing the number of acne elements, but due to the limited number of patients studied, the trial was admittedly not sufficient to detect differences with regard to therapeutic efficacy.

Topics: Acne Vulgaris; Administration, Topical; Clinical Trials as Topic; Drug Eruptions; Drug Evaluation; Erythema; Humans; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Adult; Benzoates; Female; Humans; Male; Peroxides; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Child; Clinical Trials as Topic; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Male; Ointments; Oxytetracycline; Placebos; Tretinoin; Vitamin A

Viaminate, a retinoic acid derivative developed in China, has been clinically used for acne treatment to regulate and control keratinocyte cell differentiation and proliferation, inhibit keratinization, reduce sebum secretion, and regulate immune and anti-inflammatory functions; however, its potential molecular mechanism has not yet been elucidated. Therefore, we induced ear acne in rats using Propionibacterium acnes and sebum application. Symptoms of ear redness, epidermal thickening, inflammatory reaction, keratin overproduction, subcutaneous oil, and triglyceride (TG) accumulation improved significantly in acne model rats treated with viaminate for 30 days. Transcriptome analysis of rat skin tissues suggested that viaminate had significant regulatory effects on fatty acid metabolism and cellular keratinization pathways. Molecular target prediction suggested that toll-like receptor 2 (TLR2) may be a key target of viaminate's therapeutic mechanism. Western blotting results confirmed that viaminate inhibited the TLR2 and its downstream pathways, nuclear factor-kappa B (NF-κB) [NF-κB inhibitor alpha (IκBα)/NF-κB-p65] and mitogen-activated protein kinases (MAPKs) [MAPK p38/c-Jun N-terminal kinase (JNK)/extracellular regulated kinase 1/2 (ERK1/2)] in acne vulgaris rats. In vitro studies revealed that viaminate treatment attenuated P. acnes proliferation and P. acnes-induced inflammatory response in human keratinocytes and has an inhibitory effect on the activation of NF-κB and MAPKs, while overexpression of TLR2 attenuated these effects. In conclusion, viaminate ameliorates P. acnes-induced acne by inhibiting the proliferation and inflammatory response of keratinocytes, ascribed to the deactivation of the TLR2-mediated NF-κB and MAPK pathways.

Topics: Acne Vulgaris; Animals; Humans; Mitogen-Activated Protein Kinases; NF-kappa B; Propionibacterium acnes; Rats; Toll-Like Receptor 2; Tretinoin

Topics: Acne Vulgaris; Humans; Receptors, Retinoic Acid; Tretinoin

Simultaneous anti-. This study examined in vitro planktonic and biofilm. We acquired multifunctional liposomes with a size of 71 nm and zeta potential of 31 mV. The antimicrobial activity of SME was enhanced after liposomal encapsulation according to the reduction of minimum bactericidal concentration (MBC) by 6-fold. The multifunctional liposomes exhibited a synergistically inhibitory effect on biofilm. The cationic liposomes containing dual PK and RA represented a potential treatment to arrest bacterial infection and associated inflammation in acne.

Topics: Acne Vulgaris; Animals; Anti-Bacterial Agents; Biofilms; Cell Proliferation; Endopeptidase K; Keratinocytes; Liposomes; Mice; Tretinoin

Viaminate, a vitamin A acid drug developed in China, has been clinically used in acne treatment to regulate epithelial cell differentiation and proliferation, inhibit keratinization, reduce sebum secretion, and control immunological and anti-inflammatory actions; however, the exact method by which it works is unknown.. In the present study, acne was induced in the ears of rats using. After 30 days of treatment with viaminate, the symptoms of epidermal thickening and keratin overproduction in the ears of rats were significantly improved. Transcriptomic analysis of rat skin tissues suggested that viaminate significantly regulated the biological pathways of cellular keratinization. Gene differential analysis revealed that the S100A8 and S100A9 genes were significantly downregulated after viaminate treatment. The results of qPCR and Western blotting confirmed that viaminate inhibited the expression of S100A8 and S100A9 genes and proteins in rat and HaCat cell acne models, while its downstream pathway MAPK (MAPK p38/JNK/ERK1/2) protein expression levels were suppressed. Additional administration of the S100A8 and S100A9 complex protein significantly reversed the inhibitory effect of viaminate on abnormal proliferation and keratinization levels in acne cell models.. In summary, viaminate can improve acne by modulating S100A8 and S100A9 to inhibit MAPK pathway activation and inhibit keratinocyte proliferation and keratinization levels.

Topics: Acne Vulgaris; Animals; Calgranulin B; Cell Differentiation; Cell Proliferation; HaCaT Cells; Humans; MAP Kinase Signaling System; Propionibacterium acnes; Rats; Skin Neoplasms; Tretinoin

Acne vulgaris, a prevalent skin disorder among teenagers and young adults, can have numerous psychological consequences. Topical treatment of acne would be advantageous by reducing the risk of systemic adverse drug reactions. However, the major challenge would be skin penetration through the stratum corneum. Therefore, during this study, tretinoin (TRT) and bicalutamide (BCT) loaded niosomes with follicular targeting potential were fabricated through the thin film hydration technique. Formulation optimization was performed using the Design-Expert software and optimum formulation was characterized in terms of particle size, zeta potential, transmission electron microscopy, drug loading, and differential scanning calorimetry. In vivo follicular targeting was assessed using rhodamine B-loaded niosomes to follow the skin penetration pathways. The results showed that, the optimum formulation was spherical in shape and had an average diameter of 319.20 ± 18.50 nm and a zeta potential of - 29.70 ± 0.36 mV. Furthermore, entrapment efficiencies were 94.63 ± 0.50% and > 99% and loading capacities were 1.40 ± 0.01% and 1.48 ± 0.00% for BCT and TRT, respectively. According to the animal study results, the prepared niosomes with an average diameter of about 300 nm showed significant accumulation in hair follicles. It seems that the designed niosomal BCT-TRT co-delivery system would be promising in acne management with follicular targeting potential.

Topics: Acne Vulgaris; Animals; Liposomes; Particle Size; Skin Absorption; Tretinoin

Stem cell proliferation and differentiation must be carefully balanced to support tissue maintenance and growth. Defective stem cell regulation may underpin diseases in many organs, including the skin. LRIG1-expressing stem cells residing in the hair follicle junction zone (JZ) support sebaceous gland homeostasis. An emerging hypothesis from observations in both mice and human holds that imbalances in key stem cell regulatory pathways such as Wnt signaling may lead to abnormal fate determination of these LRIG1

Topics: Acne Vulgaris; Animals; Hair Follicle; Hedgehog Proteins; Humans; Mice; Tretinoin; Wnt Signaling Pathway

Innate immune defense against deep tissue infection by

Topics: Acne Vulgaris; Animals; Anti-Bacterial Agents; Anti-Infective Agents; Humans; Mice; Propionibacterium acnes; Skin Diseases; Staphylococcus aureus; Tretinoin

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Drug Combinations; Gels; Humans; Tretinoin

Pattern recognition receptors are involved in innate and adaptive immunity by detecting microbial components. Bacteria have been accused to play a role in inflammatory acne. We investigated the potential involvement of Toll-like receptor (TLR)2, TLR4, TLR6, and CD14 in the direct influence of bacterial components and standard antiacne compounds on human sebocytes.. mRNA and protein expression of TLR2, TLR4, TLR6, and CD14 in SZ95 sebocytes was evaluated by real-time qRT-PCR and immunocytochemistry. The effects of lipopolysaccharides (LPS) and lipoteichoic acid on TLR2, TLR4, and CD14 expression and of cytokine/chemokine secretion by 13-cis-retinoic acid, all-trans-retinoic acid, retinol, and hydrocortisone at the mRNA and protein levels were assessed by real-time qRT-PCR and ELISA and verified by cocultivation with neutralizing antibodies.. The constitutive expression of TLR2, TLR4, and CD14 in SZ95 sebocytes was augmented by exposure to LPS. Hydrocortisone induced TLR2, but markedly reduced TLR4 expression. 13-cis-retinoic acid and all-trans-retinoic acid regulated IL-6 release. LPS enhanced and hydrocortisone reduced cytokine and chemokine release. Anti-TLR4 and anti-CD14 mAb blocked LPS-induced IL-8 and IL-6 release.. Microbial components use pattern recognition receptors to directly activate sebocytes to express a wide range of proinflammatory molecules and especially IL-8 and IL-6 in a TLR4- and CD14-specific manner. Retinoids, but mostly corticosteroids, also use this pathway to exhibit anti-inflammatory effects.

Topics: Acne Vulgaris; Cell Culture Techniques; Humans; Hydrocortisone; Inflammation Mediators; Isotretinoin; Lipopolysaccharide Receptors; Lipopolysaccharides; Real-Time Polymerase Chain Reaction; Retinoids; RNA, Messenger; Sebaceous Glands; Teichoic Acids; Toll-Like Receptors; Tretinoin; Vitamin A

Retinyl palmitate (RP), the most stable vitamin A derivative, is used to treat photoaging and other skin disorders. The need to minimize the adverse effects of topical drug administration has led to an enhanced interest in loading RP on ethosomes for topical drug delivery. The aim of the current study was to prepare and compare the performance of RP decorated ethosomal hydrogel with tretinoin cream in the treatment of acne vulgaris as an approach to improve drug efficacy and decrease its side effects.. RP-loaded ethosomes were prepared using the injection sonication technique. A Box-Behnken design using Design Expert. The optimized ethosomal RP showed particle size of 195.8±5.45 nm, ZP of -62.1±2.85 mV, EE% of 92.63±4.33%, drug release % of 96.63±6.81%, and drug permeation % of 85.98 ±4.79%. Both the optimized RP ethosomal hydrogel and tretinoin effectively reduced all types of acne lesions (inflammatory, non-inflammatory, and total lesions). However, RP resulted in significantly lower non-inflammatory and total acne lesion count than the marketed tretinoin formulation. Besides, RP-loaded ethosomes showed significantly improved tolerability compared to marketed tretinoin with no or minimal skin irritation symptoms.. RP ethosomal hydrogel is considerably effective in controlling acne vulgaris with excellent skin tolerability. Therefore, it represents an interesting alternative to conventional marketed tretinoin formulation for topical acne treatment.

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Animals; Diterpenes; Drug Delivery Systems; Drug Liberation; Female; Humans; Hydrogels; Male; Particle Size; Prospective Studies; Rats, Wistar; Retinyl Esters; Skin Absorption; Skin Irritancy Tests; Tretinoin

Isotretinoin is chemically named as: (2Z, 4E, 6E, 8E)-3,7-Dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetraenoic acid. It is an orally active retinoic acid derivative for the treatment of severe refractory nodulocystic acne. It acts primarily by reducing sebaceous gland size and sebum production, and as a result alters skin surface lipid composition. Using isotretinoin for 1-2mg/kg/day for 3-4 months produces 60%-95% clearance of inflammatory lesions in patients with acne. Doses as low as 0.1mg/kg/day have also proven successful in the clearance of lesions. Encouraging results have also been seen in small numbers of patients with rosacea, Side effects affecting the mucocutaneous system and raised serum triglyceride levels occur in most patients receiving isotretinoin. Isotretinoin is strictly contraindicated in women of childbearing potential. This profile discusses and explains names of isotretinoin, its physical and chemical characteristics. It also includes methods of preparation, thermal and spectral behavior, methods of analysis, and pharmacology.

Topics: Acne Vulgaris; Contraindications, Drug; Female; Humans; Isotretinoin; Sebaceous Glands; Sebum; Tretinoin

Acne vulgaris is one of the most common chronic diseases worldwide with the high prevalence ratio of about 80-85% in patients who are in puberty period. For the treatment options, many conventional dosage forms are available; however, existing limitations of systemic administration of drugs (oral antibiotics), such as adverse events and resistance, led for seek of new formulation options. In this study, liposomes containing tetracycline HCl and tretinoin were prepared by the film formation method.

Topics: Acne Vulgaris; Animals; Anti-Bacterial Agents; Biofilms; Cells, Cultured; Drug Combinations; Drug Compounding; Hydrogels; Liposomes; Mice; Microbial Sensitivity Tests; Molecular Structure; Particle Size; Staphylococcus; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Ascorbic Acid; Female; Humans; Iontophoresis; Male; Treatment Outcome; Tretinoin

INTRODUCTION: Acne vulgaris can cause pain/discomfort and have a negative impact on quality of life (QOL). Clin-RA is an acne treatment consisting of clindamycin phosphate 1.2% and tretinoin 0.025%, which has been proven effective and well tolerated in clinical studies. This prospective, non-interventional study aimed to capture data on previous treatment, acne severity, and QOL in patients with acne treated with Clin-RA and assess the efficacy and tolerability of Clin-RA in routine clinical practice.\ \ METHODS: The study was performed at 18 centers in Sweden and enrolled patients aged ≥15 years with acne, who were prescribed Clin-RA for the first time. The observation period was ~12 weeks. The primary objective was to assess the patient’s perception of their facial acne severity before and during Clin-RA treatment using a visual analog scale (VAS; 100 mm scale). Secondary objectives included QOL evaluation before and after treatment, using the Dermatology Life Quality Index (DLQI) questionnaire.\ \ RESULTS: 84 patients were enrolled and eligible for analyses (79.8% female; mean age 22.6 years). Patient-assessed VAS scores for acne severity decreased continuously during the study, indicating improvement: the median percentage reduction from baseline for VAS score was 17.6% at week 4 and 63.8% at week 12, with changes from baseline being statistically significant (P=0.0004 at week 4; P<0.0001 at weeks 8 and 12). Overall, QOL improved after Clin-RA treatment, reflected by a decrease in the mean (standard deviation) DLQI sum score from 8.8 (5.8) on day 0 to 4.9 (4.2) at week 12. Seventy percent of patients were satisfied/very satisfied with treatment. Clin-RA was well tolerated, with no serious adverse drug reactions reported.\ \ CONCLUSIONS: Treatment with Clin-RA resulted in continuous improvement of facial acne over the course of 12 weeks, along with improved QOL and a tolerable safety profile, supporting the use of Clin-RA in clinical practice.\ \ J Drugs Dermatol. 2019;18(4):328-334.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Aged; Anti-Bacterial Agents; Child; Clindamycin; Drug Combinations; Female; Gels; Humans; Male; Middle Aged; Prospective Studies; Quality of Life; Sweden; Treatment Outcome; Tretinoin; Visual Analog Scale; Young Adult

Topics: Acne Vulgaris; Drug Carriers; Drug Compounding; Emulsions; Humans; Keratolytic Agents; Microspheres; Polymers; Porosity; Skin Cream; Solubility; Treatment Outcome; Tretinoin

Topics: Acne Vulgaris; Clinical Trials, Phase III as Topic; Delayed-Action Preparations; Drug Compounding; Drug Delivery Systems; Emulsions; Hair Follicle; Humans; Keratolytic Agents; Microspheres; Polypropylenes; Polyurethanes; Porosity; Solubility; Treatment Outcome; Tretinoin

Erythema-directed digital photography is a novel method for evaluating the efficacy and tolerability of topical acne treatments. Here, we describe three case reports in which erythema-directed digital photography was used to evaluate acne before and after up to 12 weeks of treatment with clindamycin 1%/tretinoin 0.025% (Clin-RA).. Erythema-directed digital photography was used to evaluate acne in three patients with mild-to-moderate facial acne, two of whom had refused to continue previous topical acne treatment (benzoyl peroxide 5% and clindamycin 1%/benzoyl peroxide 5%) due to persistent irritation. Acne lesions and erythema were evaluated using standard clinical photography and erythema-directed digital photography (VISIA-CR. Erythema-directed digital photography revealed background erythema from previous topical acne treatments that was not evident from standard clinical photographs and allowed a better visualization of both inflammatory and non-inflammatory lesions. In all patients, there was a clear improvement in background erythema and a reduction in acne lesions following treatment with Clin-RA.. This study has demonstrated for the first time that erythema-directed digital photography can enhance the evaluation of the efficacy and tolerability of topical acne treatments. These cases show that Clin-RA was associated with improved efficacy and tolerability vs previous treatments with topical monotherapy (benzoyl peroxide 5%) or a topical fixed-dose combination (clindamycin 1%/benzoyl peroxide 5%).

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Drug Combinations; Erythema; Female; Humans; Male; Photography; Treatment Outcome; Tretinoin; Young Adult

The current work was attempted to formulate and evaluate the topical sustained release delivery systems called cubosomes containing Tretinoin for the acne treatment. The recent patents on various formulations of tretinoin (EP0408370A2) helped in selecting a new formulation and evaluation.. Tretinoin loaded cubosomes were prepared by bottom-up technique, using varying the concentration of lipid and surfactant and keeping the drug concentration constant, a total of nine formulations of tretinoin was developed. These preparations were evaluated for surface charge, particle size, particle morphology, encapsulation efficiency, in-vivo and in-vitro release studies of gel enriched with cubosome dispersion. Finally, the stability studies of cubosomal gel were performed on optimized formulations.. Significant result were obtained with tretinoin formulation as the drug is lipophilic, so it gives more depot effect on the epidermis and good retention property. The data obtained from the formulations showed that formulation TCF-5 was the optimized formulation which exhibited better drug release and entrapment efficiency.. It can be concluded that cubosomes offer benefits of quick onset as well as the maximal release of drug with fewer side effects. Thus, cubosomes represent a capable transporter having the property to sustain the release of drug, potential to localize the drug in the skin with a possible clinical application for acne vulgaris treatment due to cubosome depot effect on the epidermis.

Topics: Acne Vulgaris; Administration, Topical; Delayed-Action Preparations; Drug Carriers; Drug Compounding; Drug Liberation; Drug Stability; Gels; Humans; Lipids; Particle Size; Patents as Topic; Surface Properties; Surface-Active Agents; Tretinoin

Topical agents, including retinoids and antibiotics, are commonly used to treat acne vulgaris (AV) and remain as components of acne treatment guidelines. Approved topical combination formulations offer the advantages of established efficacy, decreased frequency of application, and improved convenience for patients. This article discusses both clindamycin phosphate (CP) and tretinoin (Tret) as components of a topical aqueous-based combination gel that has been shown to be effective, safe, and well tolerated for treatment of facial AV. Clinically relevant considerations with use of this treatment are also discussed, including therapeutic advantages and potential limitations.

Topics: Acne Vulgaris; Administration, Cutaneous; Anti-Bacterial Agents; Clindamycin; Dermatologic Agents; Drug Combinations; Gels; Humans; Practice Guidelines as Topic; Tretinoin

The link between isotretinoin, treatment of a severe form of acne, and psychiatric disorders remains controversial, as acne itself could explain the occurrence of psychiatric disorders. This study aims at assessing the disproportionality of psychiatric adverse events reported with isotretinoin in the French National PharmacoVigilance Database, compared with other systemic acne treatments and systemic retinoids.. Data were extracted from the French National PharmacoVigilance Database for systemic acne treatments, systemic retinoids and drugs used as comparators. Each report was subjected to double-blind analysis by two psychiatric experts. A disproportionality analysis was performed, calculating the number of psychiatric ADRs divided by the total number of notifications for each drug of interest.. Concerning acne systemic treatments: all 71 reports of severe psychiatric disorders involved isotretinoin, the highest proportion of mild/moderate psychiatric adverse events was reported with isotretinoin (14.1%). Among systemic retinoids, the highest proportion of severe and mild/moderate psychiatric events occurred with isotretinoin and alitretinoin.. Our study raises the hypothesis that psychiatric disorders associated with isotretinoin are related to a class effect of retinoids, as a signal emerges for alitretinoin. Complementary studies are necessary to estimate the risk and further determine at-risk populations.

Topics: Acne Vulgaris; Adverse Drug Reaction Reporting Systems; Alitretinoin; Databases, Factual; Dermatologic Agents; Female; France; Humans; Isotretinoin; Male; Mental Disorders; Pharmacovigilance; Retinoids; Risk; Severity of Illness Index; Tretinoin; Young Adult

Nodulocystic acne is prone to scarring and difficult to treat with treatments other than oral isotretinoin. The aim of this article is to discuss the role of a single session of a fractional carbon dioxide (CO

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Anti-Bacterial Agents; Combined Modality Therapy; Female; Humans; Keratolytic Agents; Lasers, Gas; Low-Level Light Therapy; Tretinoin; Young Adult

This hypothesis presents acne as a PI3K-Akt-mTORC1-driven pro-survival disease of the sebaceous follicle with impaired TRAIL-mediated death signalling. It is predicted that anti-acne agents such as isotretinoin enhance death signalling and thereby readjust the disturbed balance of pro-survival and death signalling of the sebaceous follicle in acne vulgaris. For this purpose, immortalized sebocyte cultures are regarded as inapproproate models to study the key features of acne pathogenesis.

Topics: Acne Vulgaris; Apoptosis; CASP8 and FADD-Like Apoptosis Regulating Protein; Cell Survival; Humans; Mechanistic Target of Rapamycin Complex 1; Phosphatidylinositol 3-Kinase; Proto-Oncogene Proteins c-akt; Signal Transduction; TNF-Related Apoptosis-Inducing Ligand; Transforming Growth Factor beta; Tretinoin

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Cicatrix; Dermatologic Agents; Face; Hair; Humans; Male; Tretinoin

Olumacostat glasaretil (OG) is a small molecule inhibitor of acetyl coenzyme A (CoA) carboxylase (ACC), the enzyme that controls the first rate-limiting step in fatty acid biosynthesis. Inhibition of ACC activity in the sebaceous glands is designed to substantially affect sebum production, because over 80% of human sebum components contain fatty acids. OG inhibits de novo lipid synthesis in primary and transformed human sebocytes. TrueMass Sebum Panel analyses showed a reduction in saturated and monounsaturated fatty acyl chains across lipid species, including di- and triacylglycerols, phospholipids, cholesteryl esters, and wax esters in OG-treated sebocytes. There was no shift to shorter acyl chain lengths observed, suggesting that the fatty acid chain elongation process was not affected. OG is a pro-drug of the ACC inhibitor 5-(tetradecyloxy)-2-furoic acid and was designed to enhance delivery in vivo. Topical application of OG but not 5-(tetradecyloxy)-2-furoic acid significantly reduced hamster ear sebaceous gland size, indicating that this pro-drug approach was critical to obtain the desired activity in vivo. High-performance liquid chromatography analyses of hamster ear extracts showed that OG treatment increased ACC levels and the ratio of acetyl-CoA to free CoA in these animals, indicating increased fatty acid oxidation. These changes are consistent with ACC inhibition. Matrix-assisted laser desorption/ionization imaging showed that OG applied onto Yorkshire pig ears accumulated in sebaceous glands relative to the surrounding dermis. Sebaceous gland ACC represents an attractive therapeutic target given its central role in formation of sebum, a key factor in acne pathogenesis.

Topics: Acetyl-CoA Carboxylase; Acne Vulgaris; Administration, Cutaneous; Animals; Cricetinae; Disease Models, Animal; Humans; Keratolytic Agents; Prodrugs; Sebaceous Glands; Sebum; Tretinoin

Topical tretinoin is the most commonly used retinoid for acne. However, its irritative potential on the applied area and the barrier properties of the stratum corneum limit its use. The objective of the present study was to formulate tretinoin liposomal gel to obtain a formula with lower skin irritation potential and greater clinical effect. A statistical 2(4) factorial design was adopted. Sixteen formulae prepared and were properly evaluated. A candidate formula (F13G) prepared with 0.025% tretinoin, phospholipid- cholesterol-dicetylphosphate (9:1:0.01) and incorporated in 1% carbopol gel was selected for skin irritation test. Clinical study was conducted on acne patients and compared to marketed product. All liposomes formulations were spherical in shape. The addition of cholesterol in the film hydration method significantly decreased the vesicle size, and increased the percentage of incorporation efficiency at (p < 0.05). The presence of dicetylphosphate significantly increased drug release but did not affect the percentage of incorporation efficiency and vesicle size. The results of the clinical study in acne patients revealed that F13G showed significantly higher efficacy when compared to marketed product (p < 0.05).

Topics: Acne Vulgaris; Administration, Topical; Adult; Chemistry, Pharmaceutical; Cholesterol; Drug Liberation; Female; Gels; Humans; Liposomes; Male; Organophosphates; Phospholipids; Skin Irritancy Tests; Tretinoin

Topics: Acne Vulgaris; Adult; Alitretinoin; Clinical Protocols; Dermatologic Agents; Female; Food Hypersensitivity; Glycine max; Humans; Isotretinoin; Nut Hypersensitivity; Tretinoin

Retinoids (RC), alpha-hydroxy acids (AHA), and salicylic acid (BHA) treat acne through differing mechanisms of action. It is theorized that optimal improvement can be achieved by combining the RC-induced normalization of cellular differentiation, AHA-induced exfoliation in hydrophilic areas, and BHA-induced exfoliation in lipophilic areas. AHA and RC have been combined in a bioengineered molecule (AHA retinoid conjugate, or AHA-RC) delivering both lactic acid (AHA) and RC in a manner reducing retinoid-associated irritation.. To evaluate efficacy and tolerability of a twice-daily, three-product skincare regimen using AHA-RC in combination with BHA for patients with acne.. A total of 27 women (age range 20-58 years, mean 37.81 ± 10.04 years) with mild-to-moderate acne used a 3-product regimen consisting of a twice-daily cleanser and topical serum (0.1% AHA-RC, 2% salicylic acid, and 10.4% l-lactic acid), with broad-spectrum SPF 50+ sunscreen as needed, over an 8-week period. Counts were made at baseline, week 4, and week 8 of total inflammatory (papules, pustules) and noninflammatory (open comedones, closed comedones) lesions. Dryness, stinging, and other secondary endpoints were rated on a 0-5 scale.. Statistically significant reduction in inflammatory and noninflammatory lesion counts (P = 0.006 and P = 0.015, respectively) was noted at 4 weeks. Improvement continued into week 8 with highly significant (P < 0.001) reductions in both lesion counts.. The topical combination of lactic acid, SA, and AHA-RC produced acne improvement after 4 weeks with continuing cumulative improvement at 8 weeks. AHA-RC represents a new molecule combining several mechanisms of action to achieve acne improvement.

Topics: Acne Vulgaris; Adult; Anti-Infective Agents; Detergents; Drug Combinations; Female; Humans; Keratolytic Agents; Lactic Acid; Middle Aged; Salicylic Acid; Sunscreening Agents; Treatment Outcome; Tretinoin; Young Adult

Acne vulgaris is a widely prevalent chronic skin disease. Although multiple treatments are available, acne can sometimes be refractory to these treatments. The use of alternative medical therapies has increased within dermatology and for acne. This case report describes a patient in whom the addition of cedarwood oil was helpful in controlling acne.

Topics: Acne Vulgaris; Adult; Dermatologic Agents; Female; Hidradenitis Suppurativa; Humans; Oils, Volatile; Phytotherapy; Polycystic Ovary Syndrome; Tretinoin

Topical retinoids are currently approved by the US Food and Drug Administration for the treatment of acne vulgaris in nonpregnant, nonlactating patients 12 years of age and older. Their efficacy, safety, and tolerability are well documented for inflammatory and noninflammatory acne with studies repeatedly demonstrating a decrease in the number of lesions, significant improvement in acne severity, improvement in the cosmetic appearance of acne, and the prevention of acne lesions through microcomedone formation. There is some variability between prescription retinoid products regarding efficacy, safety, and tolerability; with erythema, peeling, and dryness being common, potential side effects. Due to their efficacious and safe profile, topical retinoids remain the first-line treatment for acne vulgaris.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Dermatologic Agents; Humans; Nicotinic Acids; Retinoids; Treatment Outcome; Tretinoin

Cosmetic skin care products currently in the market demonstrate an increasing trend toward antiaging products. Selection of the right formulation approach is the key to successful consumer acceptance. Nanostructured lipid carriers (NLCs) for dermal application can render added benefits to the formulation. Tretinoin a derivative of vitamin A, is a retinoid with anti-aging and anti-acne potential. The present study was aimed at formulating NLCs of tretinoin for reducing the skin irritation potential, increasing the drug loading capacity and prolonging the duration of action. The NLCs were optimized using the response surface methodology based on the particle size. Preliminary study, suggested the use of stearic acid, oleic acid, Tween 80 and Span 60 as solid lipid, liquid lipid and surfactants respectively formed a stable dispersion. NLCs of tretinoin were prepared by hot melt microemulsion and hot melt probe sonication methods. The properties of the optimized NLCs such as morphology, size, Zeta potential, stability and in vitro drug release were investigated. Tretinoin loaded NLCs in carbopol gel showed a sustained release pattern with isopropyl alcohol as the receptor fluid compared to the marketed gel using Franz diffusion cells. Eight prepared gel formulations tested were found to follow the Higuchi model of drug release. Stability studies indicated that the formulations stored at refrigeration and room temperature showed no noticeable differences in the drug content and release profiles in vitro, after a period of 4 weeks. In vivo skin irritation test on male Wister rats indicated no irritation or erythema after application of the NLCs loaded gel repeated for a period of 7 days compared to the application of marketed tretinoin gel which showed irritation and slight erythema within 3 days. The results showed that the irritation potential of tretinoin was reduced, the drug loading was increased and the drug release was prolonged by the incorporation into the NLCs.

Topics: Acne Vulgaris; Administration, Topical; Animals; Calorimetry, Differential Scanning; Cholesterol; Colloids; Drug Carriers; Drug Delivery Systems; Emulsions; Gels; Hexoses; Kinetics; Lipids; Nanostructures; Oleic Acid; Particle Size; Polysorbates; Rats; Rats, Wistar; Retinoids; Solubility; Spectroscopy, Fourier Transform Infrared; Stearic Acids; Temperature; Tretinoin; Vitamin A

Tretinoin (TRT) is a widely used retinoid for the topical treatment of acne, photo-aged skin, psoriasis and skin cancer which makes it a good candidate for topical formulation. Yet side effects, like redness, swelling, peeling, blistering and, erythema, in addition to its high lipophilicity make this challenging. Therefore, the aim of this study was the development of TRT-loaded proniosomes to improve the drug efficacy and to increase user acceptability and compliance by reducing its side effects. Nine formulae were prepared according to 3(2) factorial design and were evaluated for their morphology, vesicle size, entrapment efficiency (EE %), and% of drug released after 5 h. Hydrogel of the candidate formula, N8G (proniosomes prepared with 0.025% TRT, and Span60: cholesterol molar ratio of 3:1 and incorporated in 1% carbopol gel) was developed and evaluated for skin irritation test and clinical study in acne patients compared to marketed product. Candidate formula showed higher efficacy and very low irritation potential when compared to marketed product in human volunteers.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Calorimetry, Differential Scanning; Chemistry, Pharmaceutical; Cholesterol; Dose-Response Relationship, Drug; Drug Liberation; Egypt; Female; Humans; Hydrogels; Hydrogen-Ion Concentration; Keratolytic Agents; Liposomes; Male; Microscopy, Electron, Transmission; Particle Size; Skin Absorption; Skin Irritancy Tests; Surface-Active Agents; Tretinoin; Young Adult

A skin disease, like acne, is very common and normally happens to everyone at least once in their lifetime. The structure of the stratum corneum is often compared with a brick wall, with corneocytes surrounded by the mortar of the intercellular lipid lamellae. One of the best options for successful drug delivery to the affected area of skin is the use of elastic vesicles (niosomes) which can be transported through the skin through channel-like structures. In this study, a combination of tretinoin (keratolytic agent) and benzoyl peroxide (BPO) (a potent antibacterial) was given by using niosomes as promising carriers for the effective treatment of acne by acting on a pathogenic site. In this section, niosomal gel formulation encapsulated drugs have been evaluated for in vitro, ex vivo, and in vivo, for their predetermined characteristics; and finally the stability of the niosome gel was tested at different temperature conditions for understanding of the storage conditions required for maintaining the quality of formulation attributes. The prepared niosome was found to be in the range of 531 nm with a zeta potential of -43 mV; the entrapment efficiencies of tretinoin (TRA) and BPO niosomes were found to be 96.25%±0.56% and 98.75%±1.25%, respectively. The permeated amount of TRA and BPO from the niosomal gel after 24 hours was calculated as 6.25±0.14 μg/cm(2) and 5.04±0.014 μg/cm(2), respectively. A comparative drug retention study in Wistar rat skin using cream, an alcoholic solution, and a niosomal gel showed 11.54 μg, 2.68 μg, and 15.54 μg amounts of TRA and 68.85 μg, 59.98 μg, and 143.78 μg amounts of BPO were retained in the layers of skin, respectively. In vivo studies of the niosomal gel and antiacne cream of TRA and BPO showed that the niosomal gel was more efficacious than the antiacne cream because niosomal gels with a 4.16-fold lower dose of BPO provided the same therapeutic index at targeted sites in comparison to the antiacne cream.

Topics: Acne Vulgaris; Animals; Anti-Bacterial Agents; Benzoyl Peroxide; Disease Models, Animal; Drug Delivery Systems; Drug Resistance, Bacterial; Gels; Liposomes; Microbial Sensitivity Tests; Microscopy, Electron, Transmission; Particle Size; Rabbits; Rats; Rats, Wistar; Skin; Staphylococcus epidermidis; Tretinoin

Retinoids play a very important role in the topical treatment of acne vulgaris. However, their use is restricted because of the limited photostability responsible for local adverse effects as erythema, dryness, itching, and stinging. In this way, the therapeutic efficacy of such molecules is strongly reduced, resulting, at the same time, harmful for the patient upon light exposure. Thus, a suitable technological strategy is necessary to increase retinoid stability in order to have a product both safe and efficacious. With this aim, new inorganic-organic hybrids based on tretinoin (retinoic acid, RET) and hydrotalcite-like compounds (HTlc) have been prepared and well characterized by X-ray powder diffraction, inductively coupled plasma spectrometry, thermal analyses, scanning electron microscopy, and UV-Vis spectrophotometric measurements. Such hybrids, namely, ZnAl-HTlc-RET and MgAl-HTlc-RET, were formulated as simple gels for topical use and submitted to further studies in order to evaluate their rheological properties, photostability, and RET release capability. The RET photostability resulted improved upon intercalation into HTlc, both in MgAl-HTlc and ZnAl-HTlc, as proved by the data acquired during irradiation of the sample at 366 nm. This strategy is suitable for the realization of safe, efficacious, and compliant topical formulations for acne treatment.

Topics: Acne Vulgaris; Administration, Topical; Aluminum Hydroxide; Chemistry, Pharmaceutical; Drug Delivery Systems; Excipients; Gels; Humans; Keratolytic Agents; Magnesium Hydroxide; Rheology; Tretinoin; X-Ray Diffraction

Topical therapy is the first choice for the treatment of mild to moderate acne and all-trans retinoic acid is one of the most used drugs. The combination of retinoids and antimicrobials is an innovative approach for acne therapy. Recently, lauric acid, a saturated fatty acid, has shown strong antimicrobial activity against Propionibacterium acnes. However, topical application of retinoic acid is followed by high incidence of side-effects, including erythema and irritation. Solid lipid nanoparticles represent an alternative to overcome these side-effects. This work aims to develop solid lipid nanoparticles loaded with retinoic acid and lauric acid and evaluate their antibacterial activity. The influence of lipophilic stearylamine on the characteristics of solid lipid nanoparticles was investigated. Solid lipid nanoparticles were characterized for size, zeta potential, encapsulation efficiency, differential scanning calorimetry and X-ray diffraction. The in vitro inhibitory activity of retinoic acid-lauric acid-loaded solid lipid nanoparticles was evaluated against Propionibacterium acnes, Staphylococcus aureus and Staphylococcus epidermidis. High encapsulation efficiency was obtained at initial time (94 ± 7% and 100 ± 4% for retinoic acid and lauric acid, respectively) and it was demonstrated that lauric acid-loaded-solid lipid nanoparticles provided the incorporation of retinoic acid. However, the presence of stearylamine is necessary to ensure stability of encapsulation. Moreover, retinoic acid-lauric acid-loaded solid lipid nanoparticles showed growth inhibitory activity against Staphylococcus epidermidis, Propionibacterium acnes and Staphylococcus aureus, representing an interesting alternative for the topical therapy of acne vulgaris.

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Drug Stability; Lauric Acids; Microbial Sensitivity Tests; Nanoparticles; Particle Size; Propionibacterium acnes; Staphylococcus; Tretinoin

To access the efficacy of spironolactone and topical retinoids in the treatment of female cyclical acne.. A retrospective chart review on 41 female patients age 19-57 years old with cyclical acne was performed. Patients were examined over the course of 2 to 102 months while taking 50 to 200 mg of spironolactone and topical tretinoin 0.025% or adapalene 0.1% cream. All were diagnosed with acne rated mild to severe, prior to treatment, and were started on an initial dose of 50 mg po daily. If significant improvement was not seen within the first 3-6 months, the dose was either held or increased in 25 mg increments every 3 months. Patients on oral and topical antibiotics, as well as patients on photodynamic therapy were excluded from the study. The response to treatment was rated on a 0-4 scale with 0 being no response and 4 corresponding to clear skin.. One patient (2.4%) had no response to treatment. This patient was only on 50 mg po daily for only 2 months. Only 5 (12.2%) patients had minimal response to treatment and 9 (22.0%), 12 (29.3%), and 14 (34.1%) had a good, excellent, or clear response respectively. The study showed 26 (63.4%) women on treatment with spironolactone and topical retinoids had an excellent or clear outcome, and 35 (85.4%) were considered to have a good, excellent, or clear response.. The addition of spironolactone to topical retinoid treatment suggests a superior response to retinoids alone in clearance of female adult cyclical acne.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Adult; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Middle Aged; Naphthalenes; Retrospective Studies; Severity of Illness Index; Spironolactone; Treatment Outcome; Tretinoin; Young Adult

In this issue, Hellmann-Regen et al. suggested that anti-acne effects of erythromycin and tetracyclines may be related to their inhibitory effect of cytochrome P450-mediated degradation of all-trans-retinoic acid (ATRA). We have recently proposed that all anti-acne agents function by attenuation of increased mTORC1 signalling. This commentary links the P450 system to mTORC1 regulation in acne. Drug-mediated induction of P450 activity or P450 mutants with increased catabolic activity may reduce cellular ATRA levels and FoxO1 expression, thus reducing FoxO-mediated mTORC1 inhibition. In contrast, agents blocking ATRA degradation such as erythromycin and tetracyclines may improve acne by increasing FoxO1 expression with consecutive inhibition of mTORC1 signalling.

Topics: Acne Vulgaris; Erythromycin; Humans; Tetracyclines; Tretinoin

Aim. The aim of this study was to evaluate the platelet counts and the mean platelet volume in patients who received isotretinoin for the treatment of acne vulgaris. Method. A total of 110 patients were included in this retrospective study. Complete blood count parameters were recorded prior to and three-months following the treatment. Results. Both platelet counts and the mean platelet volume were significantly decreased following the treatment. No significant differences were noted on the levels of hemoglobin, hematocrit, and white blood cell count. Conclusion. Platelet counts and mean platelet volume significantly decreased following isotretinoin treatment. Since the decrease of platelet counts and the mean platelet volume was seen concomitantly, it is concluded that the effect of isotretinoin was through the suppression of bone marrow.

Topics: Acne Vulgaris; Adolescent; Adult; Cell Size; Female; Humans; Male; Platelet Count; Tretinoin; Young Adult

For decades, retinoic acid (RA) is known as the most potent therapeutic option in the therapy of acne and altered homeostasis of endogenous retinoids has been discussed in the context of acne pathogenesis. Besides retinoids, antibiotics such as tetracyclines or erythromycin are well established in acne pharmacotherapy. Accumulating evidence points towards common molecular pathways being targeted by both RA and anti-acne antibiotics; however, a precise 'common denominator' connecting these chemically diverse anti-acne agents has not yet been identified. Interestingly, tetracyclines are associated with the occurrence of pseudotumor cerebri, a rare neurological side effect otherwise associated with retinoid intoxication or RA exposure. This association at the clinical level suggests an interaction between tetracyclines and endogenous RA signalling. As erythromycin does not cross the blood brain barrier, CNS side effects are not to be expected, yet not precluding a possible local interaction of erythromycin with endogenous RA metabolism in the skin. We hypothesize tetracyclines and erythromycin to locally inhibit endogenous RA metabolism in the skin and thus mimic therapeutic action of RA. This readily testable hypothesis suggests inhibition of endogenous RA metabolism and amplification of endogenous RA signalling as a mechanism underlying the biochemical actions of antibiotics in acne therapy. Elucidation of such interactions may ultimately enhance our understanding of acne therapy and pathogenesis and may yield a sound, scientific basis for hypothesis-driven development of novel therapeutic compounds.

Topics: Acne Vulgaris; Cytochrome P-450 Enzyme System; Erythromycin; Humans; Tetracyclines; Tretinoin

The aim of this study was to develop lipid nanocarriers that combine tretinoin and tetracycline for the efficient topical delivery to treat acne vulgaris. Two different nanocarriers, nanoemulsions (NEs) and nanostructured lipid carriers (NLCs), were prepared, and we examined their average size, zeta potential, drug encapsulation percentage, and drug permeation via the skin. The antibacterial activities of the nanosystems against Staphylococcus aureus, Pseudomonas aeruginosa, and Propionibacterium acnes were evaluated by an agar diffusion assay and the amount of total protein. A ca. 200-nm particle size was achieved with the prepared nanoparticles. The size increased when incorporating a cationic surfactant. Dual-drug loading did not largely affect the size of negatively charged nanoparticles, but significantly reduced the particle size of positively charged nanocarriers. NEs and NLCs exhibited high entrapment of tretinoin which ranged 60-100%. Tetracycline mainly resided in the aqueous phase, with ca. 10% of molecules located at the particulate interface. An in vitro skin permeation study showed that NLCs enhanced tetracycline flux by about 2-times over the control solution. Tretinoin permeation was generally unaffected after nanoparticulate encapsulation. There was no significant difference in tretinoin delivery before or after tetracycline incorporation, while tetracycline permeation significantly decreased by 2-fold in the dual-drug system. Nanoparticulate loading mostly maintained the antibacterial activity of tetracycline. Negatively charged NEs and NLCs even strengthened the antibacterial ability against S. aureus compared to the control solution. This is the first report examining skin permeation and antibacterial activities of dual-drug nanocarriers for acne treatment.

Topics: Acne Vulgaris; Administration, Topical; Animals; Anti-Bacterial Agents; Drug Carriers; Emulsions; Female; Keratolytic Agents; Lipids; Mice; Mice, Inbred BALB C; Mice, Nude; Nanoparticles; Propionibacterium acnes; Pseudomonas aeruginosa; Skin; Skin Absorption; Staphylococcus aureus; Tetracycline; Tretinoin

Tretinoin (TRE) or all-trans retinoic acid is employed in the topical treatment of various skin diseases including acne and psoriasis. However, its use is strongly limited by side effects and high chemical instability. TRE encapsulation in nanostructured systems reduces these problems. Chitosan is a biopolymer that exhibits a number of interesting properties such as bioadhesion and antibacterial activity. The aim of this work was to prepare and characterize solid lipid nanoparticles (SLN) containing TRE, with and without addition of chitosan, to assess their in vitro cytotoxicity in keratinocytes and to evaluate their antibacterial activity against bacteria related to acne. SLN without (SLN-TRE) and with (SLN-chitosan-TRE) chitosan were prepared by hot high pressure homogenization. The hydrodynamic mean diameter and zeta potential were 162.7±1.4 nm and -31.9±2.0 mV for SLN-TRE, and 284.8±15.0 nm and 55.9±3.1 mV for SLN-chitosan-TRE. The SLN-chitosan-TRE exhibited high encapsulation efficiency, high physical stability in the tested period (one year), were not cytotoxic to keratinocytes and showed high antibacterial activity against P. acnes and S. aureus. Therefore chitosan-SLN can be good candidates to encapsulate TRE and to increase its therapeutic efficacy in the topical treatment of acne.

Topics: Acne Vulgaris; Administration, Topical; Cell Survival; Cells, Cultured; Chitosan; Drug Carriers; Drug Compounding; Drug Stability; Humans; Keratinocytes; Lipids; Microbial Sensitivity Tests; Microscopy, Electron, Transmission; Nanoparticles; Particle Size; Propionibacterium acnes; Staphylococcus aureus; Tretinoin

Combination therapy addressing multiple pathogenic factors should be used to achieve optimal outcomes in treating acne. The following study demonstrated both safety and efficacy of fixed-dose clindamycin phosphate 1.2%/benzoyl peroxide 2.5% in the morning with micronized tretinoin 0.05% gel in the evening. Both products were applied to the skin following the use of a ceramide containing moisturizing lotion.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Benzoyl Peroxide; Ceramides; Clindamycin; Drug Administration Schedule; Drug Therapy, Combination; Female; Gels; Humans; Male; Treatment Outcome; Tretinoin; Young Adult

Topics: Acne Vulgaris; Anti-Bacterial Agents; Clindamycin; Female; Humans; Keratolytic Agents; Male; Plant Oils; Rosacea; Salicylic Acid; Sesquiterpenes; Tretinoin

Tretinoin is widely used in the treatment of acne. Despite significant advances in formulation development, irritation and dryness can be particularly bothersome, especially during the first 3-4 weeks, impacting adherence. Dose titration and adjunct use of moisturizers have been commonly employed. Co-prescribing with benzoyl peroxide (BPO) or a BPO/antibiotic combination is also common practice. The tretinoin molecule is unstable and can be degraded by BPO, further complicating treatment regimens. Lately, formulation technology has focused on providing more efficient penetration of the tretinoin into the skin layers so that lower concentrations of tretinoin might afford better tolerability, but maintain good efficacy; incorporating moisturizing excipients to minimize irritation; and providing greater stability to the tretinoin molecule. This approach would be particularly relevant in a pediatric acne population where efficacy/tolerability balance is important and treatment regimens must take into account lifestyles, but little data exist on the use of tretinoin in this patient population. A micronized formulation of tretinoin (0.05%) gel has been developed that provides a more efficient delivery of tretinoin, because of its optimal particle size, no degradation by BPO and better cutaneous tolerability than tretinoin microsphere (0.1%) gel without compromising efficacy in a pediatric population.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Dermatologic Agents; Drug Stability; Drug Therapy, Combination; Gels; Humans; Keratolytic Agents; Particle Size; Tretinoin

Topics: Acne Vulgaris; Anti-Bacterial Agents; Dermatologic Agents; Humans; Isotretinoin; Keratolytic Agents; Tretinoin

The goals were to assess the degree of improvement of facial acne after treatment with the 0.04% tretinoin microsphere gel (TMG) among patients 8 to 12 years of age and to assess tolerability and safety.. An open-label study was conducted with 40 patients 8 to 12 years of age (mean age: 10.7 years) with mild/moderate acne, defined on the basis of Evaluator's Global Severity Score (EGSS) values between 2 and 3. Patients were treated with the 0.04% TMG for 12 weeks and were evaluated at baseline and weeks 3, 6, and 12. Primary end points were changes in EGSS and Alternative Evaluator's Global Severity Score values; the secondary efficacy end point was the Investigator's Global Evaluation of treatment responses at week 12.. The mean EGSS value decreased significantly from baseline to week 12 (2.6 vs 2.1; P < .001), with 75% of cases being graded as almost clear or mild. The mean Alternative Evaluator's Global Severity Score value decreased from 3.1 to 2.4 during the 12-week period (P < .001). The mean Investigator's Global Evaluation score was 3.39 at week 12, indicating moderate improvement of acne. Treatment-associated adverse events were minimal, with mild skin irritation being most commonly recorded, generally in the first 3 weeks of therapy.. The 0.04% TMG pump was effective and safe for the treatment of acne vulgaris in this 8- to 12-year-old population, and the treatment was generally well tolerated. Additional studies in this population are recommended, to confirm these results.

Topics: Acne Vulgaris; Child; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Treatment Outcome; Tretinoin

Tetracyclines are a commonly prescribed medication for the treatment of acne vulgaris that are associated with pseudotumor cerebri (PTC). With doxycycline specifically, however, the incidence of PTC is very rare. A patient was using oral doxycycline and topical retinoids for acne, and within two months she developed PTC. This case illustrates that despite the rarity of doxycycline-induced PTC, patients and physicians should be aware of this possibility. Furthermore, in the setting of new-onset headaches or visual changes, early ophthalmologic examination for papilledema is recommended for early diagnosis.

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Doxycycline; Female; Humans; Keratolytic Agents; Pseudotumor Cerebri; Tretinoin; Young Adult

Topics: Acne Vulgaris; Administration, Topical; Combined Modality Therapy; Cysts; Humans; Keratolytic Agents; Laser Therapy; Male; Skin Diseases; Tretinoin; Young Adult

Acne vulgaris is a widely prevalent skin disorder primarily treated with retinoids, which have been shown to cause skin irritation. This report describes the combined analysis of 2 similar phase 3 studies designed to evaluate the efficacy and safety of an aqueous gel formulation of tretinoin relative to its vehicle (both studies) and a marketed microsphere formulation of tretinoin (one study) for once-daily topical treatment of acne. Randomized participants 10 years and older with mild to moderate acne (N=1537) received tretinoin gel 0.05% (n=674), tretinoin gel microsphere 0.1% (n=376), or vehicle (n=487) once daily for 12 weeks. Tretinoin gel was more effective than vehicle in reducing inflammatory (P<.001) and noninflammatory (P<.001) lesion counts over 12 weeks. Treatment success rate (global severity score, 0 or 1) was significantly greater in the tretinoin gel 0.05% group compared with the vehicle group (P<.001). The efficacy rate of tretinoin gel 0.05% was approximately 12% less than tretinoin gel microsphere 0.1%. Adverse events (AEs) were generally mild to moderate and rarely resulted in participant discontinuation. Incidence of skin-related AEs in the tretinoin gel 0.05% group (31%) was significantly lower compared with the tretinoin gel microsphere 0.1% group (52%)(P<.001). Thus, tretinoin gel 0.05% applied once daily is a well-tolerated and effective therapy for acne vulgaris and is associated with a low incidence of skin-related AEs.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Aged; Child; Clinical Trials, Phase III as Topic; Dermatologic Agents; Female; Gels; Humans; Male; Microspheres; Middle Aged; Randomized Controlled Trials as Topic; Treatment Outcome; Tretinoin

Isotretinoin is effective in the treatment of severe acne and rosacea. Both parent drug and its main metabolite 4-oxo-isotretinoin are potentially teratogenic compounds and contain a carboxylic acid moiety. In the presence of ethanol, naturally occurring as well as synthetic retinoids also containing a carboxylic acid moiety are capable of undergoing an ethyl esterification with the metabolic formation of more lipophilic compounds with a much longer terminal half-life.. To determine if isotretinoin (13-cis-RA), its main metabolite 4-oxo-isotretinoin (4-oxo-13-cis-RA), and other possible metabolites in the presence or absence of ethanol are converted to their corresponding ethyl derivatives in patients with severe acne or rosacea after multiple isotretinoin dosing. In addition, pharmacokinetic parameters of the parent drug and its 4-oxo metabolite were determined.. Eleven patients with severe acne or rosacea were treated with isotretinoin daily for 3 months and investigated pharmacokinetically during 24 h after 1 month of treatment and for up to 28 days after discontinuation of therapy. A possible influence of ethanol was evaluated using a simple self-administered questionnaire and by measuring serum ethanol levels during treatment. The concentrations of isotretinoin, 4-oxo-isotretinoin and possible ethylated and nonethylated metabolites were measured by reverse-phase high-performance liquid chromatography.. Although seven of 11 patients had a considerable weekly alcohol intake, no endogenous synthesis of ethyl derivatives of isotretinoin, the main 4-oxo metabolite or the all-trans compounds was chromatographically detectable in any of the patients' plasma samples during the treatment period. Multiple dose pharmacokinetic data for the parent drug and its main metabolite were comparable to previous studies.. The metabolism and pharmacokinetics of isotretinoin and its main metabolites are not influenced by ethanol during long-term isotretinoin treatment. After ceasing long-term isotretinoin therapy the recommended period of 1 month for using anticonceptive measures in fertile women seems adequate.

Topics: Acne Vulgaris; Adult; Alcohol Drinking; Chromatography, High Pressure Liquid; Dermatologic Agents; Ethanol; Female; Humans; Isotretinoin; Male; Middle Aged; Rosacea; Surveys and Questionnaires; Tretinoin; Young Adult

This work aims to investigate the influence of the formation of ion pairing between all-trans retinoic acid (RA) and a lipophilic amine (stearylamine; STE) on the drug encapsulation efficiency (EE) and stability of solid lipid nanoparticles (SLNs). The SLNs were characterized for EE and size. The EE and particle size were significantly improved and reduced, respectively, when the surfactant or co-surfactant concentration increased. However, while the formulation without STE allowed only 13% of RA encapsulation, the EE for RA-STE-loaded SLNs was 94%. The stability studies showed a significant decrease in EE for the SLNs without STE, while, for SLNs loaded with RA and STE, the EE remained constant after 360 days. The interactions among ion pairing components and the lipid matrix were investigated through small-angle X-ray scattering (SAXS). The SAXS analysis revealed the presence of RA in the crystalline form in SLNs without ion pairing, while crystalline RA was not observed in SLNs loaded with RA/amine. Skin irritation studies showed that the SLNs loaded with the ion pairing were significantly less irritating when compared to the marketed RA-cream. This novel SLN formulation represents a promising alternative for topical treatment of acne with RA.

Topics: Acne Vulgaris; Administration, Cutaneous; Amines; Animals; Chemistry, Pharmaceutical; Drug Delivery Systems; Drug Stability; Electrochemical Techniques; Emulsions; Exanthema; Excipients; Female; Mice; Mice, Hairless; Nanoparticles; Particle Size; Phase Transition; Scattering, Small Angle; Surface Properties; Surface-Active Agents; Tretinoin; X-Ray Diffraction

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Humans; Keratolytic Agents; Male; Peripheral Nervous System Diseases; Treatment Outcome; Tretinoin

This office-based case series describes the use of a new formulation of benzoyl peroxide (BPO) delivered via a porous microsphere cream vehicle in patients with mild to moderate acne vulgaris. While BPO has been used for many years as antimicrobial in the treatment of acne, in recent years its use has been increasingly encouraged as part of a strategy designed to reduce Propionibacterium acnes (P acnes) resistance to antibiotics. Historically, a major drawback to BPO treatment has been irritation, which may be concentration-dependent or vehicle-dependent. A new BPO microsphere cream formulation has recently been introduced and appears to offer favorable efficacy with a very low potential for irritation. This article presents a series of patients from 2 private dermatologic practices treated with a new BPO microsphere cream formulation both as monotherapy and in combination with other acne drugs.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Keratolytic Agents; Male; Microspheres; Minocycline; Naphthalenes; Tretinoin

Localized irritation can limit treatment success with topical retinoids such as tretinoin and adapalene. The factors that influence irritant reactions have been shown to include individual skin sensitivity, the particular retinoid and concentration used, and the vehicle formulation.. To compare the cutaneous tolerability of tretinoin 0.04% microsphere gel (TMG) with that of adapalene 0.3% gel and a standard tretinoin 0.025% cream.. The results of 2 randomized, investigator-blinded studies of 2 to 3 weeks' duration, which utilized a split-face method to compare cumulative irritation scores induced by topical retinoids in subjects with healthy skin, were combined. Study 1 compared TMG 0.04% with adapalene 0.3% gel over 2 weeks, while study 2 compared TMG 0.04% with tretinoin 0.025% cream over 3 weeks.. In study 1, TMG 0.04% was associated with significantly lower cumulative scores for erythema, dryness, and burning/stinging than adapalene 0.3% gel. However, in study 2, there were no significant differences in cumulative irritation scores between TMG 0.04% and tretinoin 0.025% cream. Measurements of erythema by a chromameter showed no significant differences between the test formulations in either study.. Cutaneous tolerance of TMG 0.04% on the face was superior to that of adapalene 0.3% gel and similar to that of a standard tretinoin cream containing a lower concentration of the drug (0.025%).

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adult; Dermatologic Agents; Female; Humans; Irritants; Naphthalenes; Randomized Controlled Trials as Topic; Skin; Tretinoin

Facial acne is common in adolescents and can have a significant psychosocial impact. Treatments prescribed should not add stress by causing excessive localized irritation.. To determine whether the lowest concentration of tretinoin microsphere gel (TMG) currently available (0.04%) provides an acceptable balance of efficacy and tolerability for adolescents with moderate facial acne.. The findings of 2 multicenter, randomized, double-blind, vehicle-controlled trials of TMG 0.04% applied once nightly for 12 weeks in 245 adolescents ages 11 to 16 years with moderate facial acne were combined. Patients were evaluated via changes in acne lesion counts and the occurrence of cutaneous and other adverse effects.. Tretinoin microsphere gel 0.04% reduced total, noninflammatory, and inflammatory lesion counts to a significantly greater extent than the vehicle gel at 12 weeks (P<.000005). The mean percentage reductions in noninflammatory and inflammatory lesion counts at 12 weeks in females were 45.0% and 51.4%, respectively; and in males, 20.5% and 36.7%, respectively. Tretinoin microsphere gel 0.04% was tolerated well, with over 70% of patients experiencing no cutaneous adverse events (AEs).. Tretinoin microsphere gel 0.04% is effective in significantly reducing all types of acne lesions in adolescents with moderate facial acne ages 11 to 16 years, and has a low incidence of cutaneous AEs.

Topics: Acne Vulgaris; Adolescent; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Randomized Controlled Trials as Topic; Tretinoin

True objective measures for assessing responsiveness to acne treatments are lacking. Photographic documentation can therefore be a valuable adjunct to treatment assessment.. To photographically document the ability of tretinoin microsphere gel (TMG) 0.1% in improving facial acne.. A standardized photographic technique was used to assess the efficacy and tolerability of TMG 0.1% applied once nightly for 12 weeks in an open-label trial involving 30 patients (Caucasian and Hispanic) ages 11 to 40 years with moderately severe facial acne.. An assessment of frontal, left-sided, and right-sided color photographs at week 12 indicated that TMG 0.1% reduced total, noninflammatory, and inflammatory acne lesion counts by 47.8%, 53.5%, and 33.2%, respectively; and produced an "excellent/ good" investigator's global evaluation (4-point scale) treatment response in 63.6% of patients. Tretinoin microsphere gel 0.1% was well tolerated, and more than 63% of subjects did not exhibit cutaneous adverse effects at week 12.. The standardized photographic technique proved to be a useful tool for documenting the efficacy of TMG 0.1% in consistently and significantly improving moderately severe facial acne over a 12-week treatment period.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Female; Gels; Humans; Keratolytic Agents; Male; Microspheres; Photography; Tretinoin

Retinoic acid is a widely used drug in the treatment of cystic acne. It has teratogenic effects that depend on the gestational period in which it is used. We report a seven months old female whose mother was exposed to retinoic acid in both pre-gestational and gestational periods. She had a retardation of psychomotor development and a brain MRI showed frontal atrophy and a malformation of the posterior fossa. We discuss the mechanisms of the teratogenic effects of retinoic acid.

Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Acne Vulgaris; Atrophy; Cranial Fossa, Posterior; Craniofacial Abnormalities; Female; Frontal Lobe; Humans; Infant; Isotretinoin; Keratolytic Agents; Maternal Exposure; Pregnancy; Prenatal Exposure Delayed Effects; Psychomotor Disorders; Teratogens; Tretinoin

Clindamycin phosphate 1.2% together with tretinoin 0.025% as a gel (CTG) is a topical formulation of a fixed and stable combination approved by the FDA for the treatment of acne vulgaris in patients 12 years of age or older. The main indication of CTG is the management of moderate comedonal and mild-to-moderate papulopustular acne, an acne form which is present in more than 50% of acne patients. CTG can also be combined with systemic antiacne therapy, such as systemic isotretinoin, in nodulocystic acne. The product combines the anti-inflammatory and antibacterial properties of clindamycin with the well proven and beneficial comedolytic and anticomedogenic effects of tretinoin (all-trans retinoic acid). The addition of clindamycin to tretinoin enhances the comedolytic efficacy of tretinoin in moderate-to-severe acne of the face. The comedolytic activity of tretinoin and the anti-inflammatory efficacy of clindamycin accelerate resolution of all types of acne lesions without affecting the safety of both compounds. Discontinuation rates due to adverse events related to this formulation were found to be low (

Topics: Acne Vulgaris; Clindamycin; Dosage Forms; Gels; Humans; Treatment Outcome; Tretinoin

Acne vulgaris affects most people at some time in their life. This common condition can have devastating effects on a person's quality of life and may leave permanent scars. Treatment options, which are designed to disrupt one or more of the pathogenic features that characterize acne, include topical therapies (e.g., antibiotics, retinoids, benzoyl peroxide and combination products), systemic treatments (e.g., oral antibiotics, hormonal therapies and oral retinoids, which are indicated for severe recalcitrant nodulocystic acne), and, to a lesser extent, light-based and physical treatments. Combination oral contraceptives (COCs) represent one type of hormonal treatment. Their mode of action is to reduce the availability of free testosterone, which stimulates the sebaceous glands to produce sebum. Most COCs used in the United States contain progestins derived from 19-nortestosterone, giving them at least some degree of androgenic activity. Of the 3 COCs with an FDA indication for the treatment of moderate acne, only YAZ contains drospirenone, a progestin that combines no androgenic activity with antiandrogenic activity. This drospirenone-containing COC has been shown to be effective in reducing both inflammatory and noninflammatory acne lesions.

Topics: Acne Vulgaris; Adolescent; Adult; Androstenes; Anti-Infective Agents, Local; Contraceptives, Oral, Combined; Drug Administration Schedule; Drug Approval; Drug Therapy, Combination; Ethinyl Estradiol; Female; Humans; Tretinoin

Combination acne medications provide enhanced treatment opportunities. A commonly used acne therapy may combine a topical antibiotic with benzoyl peroxide (BPO) to prevent antibiotic resistance while optimizing control of microcomedone formation with a retinoid. Unfortunately, this combination of highly efficacious medications may cause irritation because of the inherent skin irritancy of BPO and retinoids. The present study was undertaken to determine if vehicle optimization of a clindamycin-BPO formulation could increase the tolerability of an added retinoid. Forty-six women with mild to moderate facial acne were enrolled in a 3-center, institutional review board-approved, 2-week, split-face study to compare an optimized vehicle (glycerin and dimethicone) clindamycin-BPO formulation with a traditional clindamycin-BPO formulation, with tretinoin cream 0.025% applied to the entire face. The use of the optimized vehicle clindamycin-BPO formulation in combination with tretinoin cream 0.025% resulted in significantly less erythema and dryness on evaluation days 4, 7, and 14 (P < .05), as assessed by the blinded dermatologist investigators. The incorporation of new vehicles into topical dermatologic medications allows medication combinations with enhanced tolerability.

Topics: Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Dimethylpolysiloxanes; Female; Glycerol; Humans; Pharmaceutical Vehicles; Tretinoin; Young Adult

Near-infrared reflectance confocal microscopy (RCM) is a noninvasive tool that provides real-time images of thin virtual horizontal tissue sections.. We have used a rhino mouse model in combination with topical application of all-trans-retinoic acid and all-trans-retinol to investigate the usefulness of RCM as a noninvasive imaging tool to evaluate comedolysis in vivo and over time. Optical images were correlated with routine histology.. Our results demonstrate that RCM in vivo can visualize the process of transformation of utriculi (pseudocomedones) towards a normal-appearing follicular structure during retinoid treatment. The retinoic acid intervention group showed a dose-related response, while the vehicle-treated group did not show utricular changes.. RCM represents a useful tool for in vivo morphological and quantitative evaluation of skin utriculi over time and could be used as an adjunct tool to histopathological techniques for comedolysis studies.

Topics: Acne Vulgaris; Animals; Disease Models, Animal; Mice; Microscopy, Confocal; Tretinoin; Vitamin A

R115866 (Rambazole; Barrier Therapeutics NV, Geel, Belgium), a new-generation retinoic acid metabolism-blocking agent, is a nonretinoid compound enhancing intracellularly the endogenous levels of all-trans-retinoic acid by blocking its catabolism. By virtue of this property, and the proven positive effects of retinoids in the treatment of acne, R115866 could potentially be a useful drug for acne.. To explore the efficacy, safety and tolerability of systemic R115866 in male patients with moderate to severe facial acne vulgaris (at least 15 papules and/or pustules and at least two nodulocystic lesions).. In this exploratory trial, 17 patients were treated with oral R115866 1 mg once daily for 12 weeks, followed by a 4-week treatment-free period.. At the end of treatment (week 12, n = 16) a mean reduction in inflammatory lesion count of 77.4% (P < 0.001), in noninflammatory lesion count of 58.3% (P < 0.001) and in total lesion count of 76.0% (P < 0.001) was observed as compared with baseline. All lesion counts were significantly reduced from week 4 onwards. Mild side-effects were reported occasionally.. The current data indicate that treatment with oral R115866 1 mg once daily for 12 weeks in patients with moderate to severe facial acne vulgaris is efficacious and well tolerated and merits further investigation.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Benzothiazoles; Dermatologic Agents; Dose-Response Relationship, Drug; Humans; Male; Middle Aged; Patient Compliance; Tretinoin; Triazoles

The development of solid lipid nanoparticles (SLN) containing all-trans retinoic acid (RA) is an interesting approach to topical treatment of acne. SLN has potential for controlled release and follicular penetration, which can reduce adverse effects in comparison with conventional formulations. However, the encapsulation efficiency (EE) of RA in SLN is usually low, unless a high surfactant/lipid ratio is used. The aim of this work was to develop SLN with high EE using a low surfactant/lipid ratio. Different formulations of RA-loaded SLN were prepared using glyceryl behenate as lipid matrix. The particle size, EE, zeta potential and differential scanning calorimetry (DSC) were investigated. High EE in SLN was obtained with addition of amines. These results indicate that the utilization of amines is an interesting approach to improve the EE of RA in SLN using a low surfactant/lipid ratio.

Topics: Acne Vulgaris; Administration, Cutaneous; Amines; Calorimetry, Differential Scanning; Chemistry, Pharmaceutical; Crystallization; Delayed-Action Preparations; Drug Compounding; Drug Delivery Systems; Excipients; Fatty Acids; Humans; Keratolytic Agents; Microscopy, Polarization; Nanoparticles; Octanols; Particle Size; Solubility; Static Electricity; Tretinoin

Acne conglobata is an uncommon disorder characterized by the presence of nodulocystic lesions. Conservative therapy with oral and topical antibiotics is of limited efficacy in many cases, and surgical excision is often needed for removal of the cystic lesions. Treatment is particularly difficult in cases with lesions located in aesthetically sensitive areas, such as the face. We successfully treated a case of acne conglobata by CO(2) laser ablation to remove the top of the sinuses and their tracts. In addition, topical tretinoin therapy was also initiated simultaneously to prevent the appearance of new acne lesions. Based on the results, we propose that the use of CO(2) laser for opening the cysts, combined with topical tretinoin therapy to prevent the appearance of new lesions, is a powerful treatment option for acne conglobata.

Topics: Acne Vulgaris; Adult; Combined Modality Therapy; Humans; Keratolytic Agents; Laser Therapy; Male; Skin; Tretinoin

The inhibitive components in anti-acne cosmetics including spironolactone, benzoyl peroxide, and tretinoin were simultaneously determined by reversed-phase high performance liquid chromatography (RP-HPLC). The cosmetics were extracted with methanol by microwave and analyzed by high performance liquid chromatography. The HPLC conditions were as follows: Kromasil C18 column (4.6 mm i. d. x 250 mm, 5 microm), methanol and phosphate buffer as mobile phase with gradient elution at a flow rate of 1.0 mL/min, UV detection at 265 nm. Three components were separated completely within 11 min. The calibration curves of the three compounds were linear (nu > 0.999 9) between 1 and 200 mg/L. The average recoveries were from 88.2% to 106.7% with relative standard deviations lower than 3. 1%. The detection limits (S/N = 3) were 0.101 mmicrog for spironolactone, 0.100 microg for benzoyl peroxide, and 0. 107 microg for tretinoin. The method is simple and rapid with high accuracy, and suitable for the determination of the 3 inhibitive components in anti-acne cosmetics.

Topics: Acne Vulgaris; Benzoyl Peroxide; Chromatography, High Pressure Liquid; Chromatography, Reverse-Phase; Cosmetics; Dermatologic Agents; Spironolactone; Tretinoin

This article reports on recent studies and case reports that evaluated the stability, tolerability, and efficacy of clindamycin 1%-benzoyl peroxide 5% tube gel in combination with topical retinoids and oral antibiotics. Overall, these combinations appeared to be well-tolerated, effective, and, as reported in the case studies, adaptable to common clinical practice.

Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Administration, Oral; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Drug Combinations; Female; Gels; Humans; Keratolytic Agents; Male; Minocycline; Naphthalenes; Nicotinic Acids; Retinoids; Treatment Outcome; Tretinoin

A major consequence of microbial infection is the tissue injury that results from the host inflammatory response. In acne, inflammation is due in part to the ability of Propionibacterium acnes to activate TLR2. Because all-trans retinoic acid (ATRA) decreases inflammation in acne, we investigated whether it regulates TLR2 expression and function. Treatment of primary human monocytes with ATRA led to the down-regulation of TLR2 as well as its coreceptor CD14, but not TLR1 or TLR4. The ability of a TLR2/1 ligand to trigger monocyte cytokine release was inhibited by pre- and cotreatment with ATRA; however, TLR4 activation was affected by cotreatment only. ATRA also down-regulated monocyte cytokine induction by P. acnes. These data indicate that ATRA exerts an anti-inflammatory effect on monocytes via two pathways, one specifically affecting TLR2/1 and CD14 expression and one independent of TLR expression. Agents that target TLR expression and function represent a novel strategy to treat inflammation in humans.

Topics: Acne Vulgaris; Cells, Cultured; Cytokines; Down-Regulation; Humans; Inflammation Mediators; Lipopolysaccharide Receptors; Membrane Glycoproteins; Monocytes; Propionibacterium acnes; Receptors, Cell Surface; Toll-Like Receptor 1; Toll-Like Receptor 2; Toll-Like Receptor 4; Toll-Like Receptors; Tretinoin

Atrophic scars are a frequent consequence of acne, with a negative esthetic and psychological influence. Treatment of atrophic acne scars includes different invasive methods. In our study, we used a noninvasive method with local application of 0.05% tretinoin gel by iontophoresis. In patients with a tendency towards exacerbation, we performed mild peeling with 5% trichloroacetic acid (TCA) solution 3-4 times during the treatment. Twenty-minute treatments were applied on 38 patients, 29 women and 9 men, during 3.5 months on average. Median age of patients was 21 years (range, 16-29). Clinical assessment included an assessment of scars, pore size, skin moisture, vascularization, and skin firmness and elasticity. As confirmed by photographs taken before and after therapy, the treatment proved to be clinically effective in decreasing acne scars and persistence of effects. Flattening of acne scars was observed in 79% of the patients. The results depended on duration of scars persistence as well as on a the type of scars. The best results were achieved with younger scars as well as with superficial and ice pick scars. Side effects involved a very mild retinoid dermatitis and more often acne exacerbation. The therapy was clinically effective and the patients accepted the treatment very easily. Local therapy of acne scars with tretinoin by iontophoresis can in some cases successfully replace invasive techniques, and could also be combined with those techniques.

Topics: Acne Vulgaris; Adult; Cicatrix; Female; Humans; Iontophoresis; Male; Time Factors; Tretinoin

Topical tretinoin is used in the treatment of acne and other dermatoses. The most common side-effects are itching, dryness and reddening of the skin. We report an additional cutaneous reaction, which occurred in patients using topical tretinoin. Pyogenic granulomas developed in two patients with acne and in one with dermatofibroma following application of tretinoin. The granulomas grew on the lesions after 2-3 weeks of therapy initiation. All patients were men and the granulomas developed in their trunk. The lesions resolved when topical tretinoin was ceased. Although the number of patients reported is too small to estimate the true incidence of this reaction, it is likely that dermatologists will encounter similar reactions in patients treated with topical tretinoin for acne or other reasons.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Biopsy, Needle; Granuloma, Pyogenic; Humans; Immunohistochemistry; Keratolytic Agents; Male; Prognosis; Risk Assessment; Sampling Studies; Severity of Illness Index; Skin Diseases; Tretinoin

To study the potential anti-androgenic activity of roxithromycin (RXM), we previously used human dermal fibroblasts transiently transfected with the expression vector of androgen receptor (AR) coactivator ARA55 as the in vitro model reflecting the end-organ hypersensitivity.. To examine the potential anti-androgenic activity of anti-acne therapeutic agents, nadifloxacin (NDFX), RXM, all-trans retinoic acid (atRA), and glycolic acid (GA), we carried out the transient transfection assays using the CV-1 cells as a more sensitive assay system.. The result showed that 5 microg/ml of RXM suppress 10(-9)M R1881-induced AR transcriptional activity by 21.2%. 50 microg/ml of NDFX can suppress AR transcriptional activity to 29.8%. Furthermore, the assays with treatment of 1, 5, 10, or 50 microg/ml NDFX in the presence of 1 microg/ml RXM showed that 5, 10, or 50 microg/ml NDFX inhibits the AR transactivity by 32.7, 31.1 or 61.0%, respectively, indicating the synergistic effect of NDFX and RXM. Besides 10(-5)M atRA suppressed the R1881-induced luciferase activity by 50%, but GA did not alter AR transactivity.. We demonstrated that anti-acne agents available in the clinical practice can exert anti-androgenic effects in the treatment of acne.

Topics: Acne Vulgaris; Androgen Antagonists; Animals; Cell Line; Dermatologic Agents; Fluoroquinolones; Glycolates; Haplorhini; Metribolone; Quinolizines; Receptors, Androgen; Roxithromycin; Transcription, Genetic; Transfection; Tretinoin

Topical tretinoin is highly effective and widely used in the treatment of acne vulgaris. In studies to determine the degree of tretinoin photo degradation (isomerization), 2 tretinoin formulations, tretinoin gel microsphere 0.1% and tretinoin gel 0.025%, alone or in combination with erythromycin-benzoyl peroxide topical gel, were exposed to fluorescent light, incandescent light, or darkness for up to 24 hours. Results of the investigations revealed that after 24 hours of exposure to fluorescent light, 98% of the initial tretinoin in the tretinoin gel microsphere 0.1% formulation remained unchanged. When tretinoin gel microsphere 0.1% was combined with erythromycin-benzoyl peroxide topical gel and exposed to fluorescent light, 99% and 87% of the tretinoin was recovered after 4 and 24 hours, respectively, indicating only a limited amount of degradation. In contrast, exposure of tretinoin gel 0.025% to 24 hours of fluorescent light resulted in up to 69% tretinoin degradation and up to 89% degradation when the gel was combined with the erythromycin-benzoyl peroxide topical gel. The data suggest that the tretinoin gel microsphere 0.1% formulation offers marked protection against tretinoin photo degradation, even in the presence of a strong oxidizing agent such as benzoyl peroxide.

Topics: Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide; Drug Interactions; Drug Stability; Erythromycin; Gels; Humans; Keratolytic Agents; Microspheres; Time Factors; Tretinoin

Topics: Acne Vulgaris; Carcinoma, Squamous Cell; Diagnosis, Differential; Follow-Up Studies; Humans; Laryngeal Neoplasms; Male; Middle Aged; Neck; Radiation Dosage; Radiodermatitis; Radiotherapy; Risk Assessment; Severity of Illness Index; Tretinoin

Retinoids are a fascinating class of compounds that exert control over cellular function from the time of conception to death. They play a critical role in such vital processes as fetal morphogenesis, cellular differentiation and apoptosis. Over the years synthetic retinoids have provided dermatologists with a spectrum of medications that have profound therapeutic effects on a variety of recalcitrant skin disorders. Moreover, retinoids are an expanding component of the treatment arsenal against hematologic and solid malignancies. Retinoids are poised to offer exciting new therapeutic options in the field of endocrinology for the treatment of diabetes and lipid disorders. Researchers and clinicians are only beginning to unveil the therapeutic potential of this class of medications. The development of new retinoid compounds targeting specific receptors promises a wealth of new therapies for the new millennium.

Topics: Acne Vulgaris; Humans; Keratosis; Leukemia, Promyelocytic, Acute; Lymphoma, T-Cell, Cutaneous; Psoriasis; Skin Neoplasms; Treatment Outcome; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Dermatologic Agents; Dicarboxylic Acids; Drug Therapy, Combination; Female; Humans; Keratolytic Agents; Male; Nonprescription Drugs; Tretinoin

evaluation of comedone lesions, especially in vivo, remains a challenge. We have used the rhino mouse model in combination with topical application of all-trans retinoic acid as a comedolytic agent, to investigate the potential of fluorescence spectroscopy as a noninvasive technique in the assessment of noninflammatory acne. The results indicate that there is a strong correlation between the fluorescence excitation spectral features assessed in vivo, and the histologic changes identified, particularly the size of the utriculi as well as the dermal and epidermal thickness. We conclude that fluorescence excitation spectroscopy represents a promising novel and useful tool in the quantitative evaluation of the pseudocomedones and could also be used for the rapid and noninvasive assessment of comedolysis induced by the application of pharmacologic agents such as retinoids.

Topics: Acne Vulgaris; Administration, Topical; Animals; Biomarkers; Mice; Skin; Spectrometry, Fluorescence; Tretinoin

Atrophic acne scars are a frequent problem after acne. Hitherto, mainly invasive treatment measures were possible. In a recent paper, we demonstrated the positive effects of iontophoresis with 0.025% tretinoin gel vs. estriol 0.03%.. In this further study, the recording of the clinical effects of iontophoresis with 0.025% tretinoin gel in atrophic acne scars was supplemented by immunohistochemistry investigations of collagen I and III, proliferation markers, and the estimation of epidermal thickness.. The treatment was performed twice weekly in 32 volunteer patients for a period of 3 months by application of the substance under a constant direct current of 3 mA for 20 min. Skin biopsies prior to and at the end of treatment were performed in 32 voluntary patients in order to investigate collagen I/III and proliferation markers by immunohistochemistry methods.. Clinically, at the end of treatment, in 94% of patients a significant decrease in the scar depth was observed. Neither epidermal thickness nor proliferation markers revealed a significant increase at the end of treatment. Furthermore, collagen I and collagen III showed no common trend, as expressed statistically by a lack of significance. In some cases, increases in collagen III became evident at the end of treatment.. Tretinoin-iontophoresis is an effective, noninvasive treatment of atrophic acne scars without causing disturbing side-effects.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Atrophy; Cicatrix; Collagen; Female; Humans; Immunohistochemistry; Iontophoresis; Keratolytic Agents; Ki-67 Antigen; Male; Middle Aged; Skin; Treatment Outcome; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Female; Humans; Keratolytic Agents; Pregnancy; Pregnancy Complications; Tretinoin

Acne is caused by hormones, androgen, and follicular keratinization, which leads to blocked pores, and P. acnes bacteria, which cause pustule form. Dermatologists report that acne treatments, like the skin of suffers, are clearly getting better. New treatments and the refinements of mainstay ones have changed the face of acne treatment. One advantage of the newer, more effective treatments is that patients now take lower doses of antibiotics for shorter periods of time.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Dermatologic Agents; Female; Humans; Isotretinoin; Male; Middle Aged; Naphthalenes; Recurrence; Tretinoin

To determine whether prior authorization of topical tretinoin for acne is in the best interest of health insurers and, if so, to determine the optimal prior authorization age for topical tretinoin.. A retrospective, cross-sectional study of data from the National Ambulatory Medical Care Survey was performed.. We performed a sensitivity analysis using published data on the age distribution for topical tretinoin prescriptions for acne and nonacne indications to estimate the cost of topical tretinoin and the cost of performing prior authorizations as a function of the prior authorization age.. A prior authorization age of 25 for topical tretinoin is not cost effective for health insurers. If prior authorization is required, an age threshold of 35 or older is most cost effective. The total cost of topical tretinoin (the sum of the drug costs plus the prior authorization costs) changes little with changes in the prior authorization age; if the prior authorization age is set too low, total costs increase (because the number of prior authorizations increase).. Prior authorization for topical tretinoin is of no great benefit to insurers. As the prior authorization age decreases, the cost of requiring prior authorization increases. Eliminating prior authorization altogether would result in at most a small increase in costs and would be balanced by the benefits to both patients and physicians.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Age Factors; Child; Child, Preschool; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug Utilization; Health Care Surveys; Humans; Infant; Insurance Claim Review; Insurance, Pharmaceutical Services; Middle Aged; Retrospective Studies; Tretinoin

Retinaldehyde is a key molecule in the metabolism of vitamin A by keratinocytes. In order to evaluate its range of topical activity in acne, its comedolytic effect was compared to that of retinoic acid in the same vehicle, in the rhino mouse model.. The animals were treated on the back daily for 5 consecutive days per week for 3 weeks. At the end of this period, histological slides were analyzed in order to quantify the features of comedones and epidermal thickness.. Topical treatment with a retinaldehyde (0.05% w/w) and a retinoic acid formulation (0. 025% w/w) induced comedolysis and increased the epidermal thickness with the same intensity.. These data indicate that retinaldehyde exerts a significant comedolytic activity.

Topics: Acne Vulgaris; Administration, Topical; Animals; Mice; Mice, Hairless; Retinaldehyde; Skin; Tretinoin

A TLC-method was developed to analyse tretinoin and erythromycin in a lotion in the presence of several excipients. Erythromycin was separated on a silica gel plate and a mobile phase with dichloromethane, methanol and ammonia 25% (60:6:1 (v/v/v)), tretinoin on a C(18) RP plate with acetonitrile and water (50:25 (v/v)) as mobile phase, adding 1 ml acetic acid for the separation of the excipients and erythromycin. The derivatization for both was done with a dipping reagent, consisting of anisaldehyde, sulphuric acid and acetic acid (respectively 1, 2 and 10% (v/v/v)) and dissolved in chloroform/alcohol 94% v/v (60:30 (v/v)) for erythromycin and alcohol 94%/water (50:40 (v/v)) for tretinoin. These TLC-systems were quantitatively evaluated in terms of stability of the colour, precision, accuracy and calibration, proving the utility in the analysis of the lotion.

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Calibration; Chromatography, High Pressure Liquid; Chromatography, Thin Layer; Color; Densitometry; Erythromycin; Excipients; Indicators and Reagents; Keratolytic Agents; Ointments; Tretinoin

Topical tretinoin is effective treatment for both acne and photoaging. This creates a problem for insurers that cover medication costs, because treatment of acne is often covered but treatment of photoaging is not. The age distributions of patients with acne or photoaging are likely to be very different. Therefore, one approach insurers can use is an age cutoff for covering the cost of topical tretinoin therapy.. Our purpose was to determine at what age patients are more likely to receive tretinoin for treatment of acne vulgaris versus other conditions to provide a rational basis for insurers to set coverage cutoffs.. National Ambulatory Medical Care Survey data for the years 1990 to 1994 were analyzed to ascertain the age distribution of acne vulgaris office visits and treatment with topical acne agents including tretinoin. These data were compared to office visits and tretinoin treatment of wrinkles, solar elastosis, and other conditions.. The mean age (+/- standard deviation) of patients seen for acne vulgaris was 24.3 +/-11.5 years old. The age distribution of topical tretinoin treatment paralleled the age distribution of acne. Tretinoin treatment of acne and of nonacne conditions were equal at an age of 44.. The distribution of outpatient visits for acne treatment is skewed toward older patients and persists beyond age 40. A rational age cut-off for coverage of topical tretinoin treatment is 40 years.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Age Factors; Drug Utilization; Health Care Surveys; Humans; Keratolytic Agents; Middle Aged; Tretinoin; United States

Isotretinoin for oral therapy in severe acne conglobata and acne nodulocystica represents a significant achievement; however, the drug exerts several mucocutaneous and systemic adverse effects, besides its teratogenic potency.. The aim of this study was to investigate the plasma levels of isotretinoin and of 4-oxo-isotretinoin over long-term treatment of severe acne and to assess any correlation with the given dose, the clinical improvement and the occurrence of side effects.. Forty-one patients with severe acne and acne-related disorders were studied under long-term oral intake of isotretinoin. Therapeutic effects and side effects were evaluated prior, during and at the end of therapy. The plasma levels of isotretinoin and of its major metabolite 4-oxo-isotretinoin were measured by reversed-phase HPLC and were correlated with the administered oral dose and the number and frequency of side effects.. Dose-dependent plasma levels of isotretinoin and its metabolite were observed. At a mean dosage of 0.75-1.0 mg/kg/day, 404 +/- 142 ng/ml were measured, whereas the plasma levels of 4-oxo-isotretinoin were 1-2x higher. The plasma levels correlated well with the orally administered dose of isotretinoin and the observed mucocutaneous side effects.. The study demonstrates that measuring of the plasma levels may be a helpful tool to monitor the individual therapeutic dose regimen in patients with severe acne in order to minimize undesired side effects and to control oral intake.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Chromatography, High Pressure Liquid; Drug Monitoring; Female; Humans; Isotretinoin; Male; Middle Aged; Tretinoin

QUESTIONOne of my patients conceived while using a topical tretinoin preparation for acne. I know this drug is related to Accutane, which is teratogenic. How should I advise her?ANSWERAvailable evidence suggests that topical tretinoin does not increase teratogenic risk in humans.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Administration, Cutaneous; Adult; Case-Control Studies; Female; Humans; Keratolytic Agents; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Pregnancy Trimester, First; Tretinoin

More than 100 years has passed since the first report of a nevus comedonicus. The earliest reports emphasized the inflammatory aspect of the nevus comedonicus as being the most significant problem. In the past 30 years, publications have ignored the inflammatory aspect of nevus comedonicus while emphasizing a variety of associated malformations. In this review, we describe five prepubertal children with prominent and persistent inflammatory changes limited to areas within a nevus comedonicus. In our experience, inflammation can be severe and resistant to treatment. Ultimately, surgical removal of the involved skin was required in two children.

Topics: Acne Vulgaris; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antineoplastic Agents; Cheek; Child; Child, Preschool; Drug Therapy, Combination; Facial Neoplasms; Female; Humans; Infant; Male; Nevus; Shoulder; Skin Neoplasms; Thoracic Neoplasms; Tretinoin

Follicular mucinosis can be a primary idiopathic disease or a secondary disease associated with lymphoma. When it appears in childhood or adolescence, it is usually primary and self-limited. We describe four cases of follicular mucinosis occurring in early adulthood that have had protracted courses. Each presented as an unusual acneiform eruption. Two of the cases demonstrated a clonal genetic rearrangement of the T-cell receptor within the cutaneous lymphoid infiltrate, a finding not previously reported. Although its significance is not clear, the clonal lymphocytic expansion indicates a need for continued surveillance of these patients.

Topics: Acne Vulgaris; Administration, Topical; Adult; Anti-Bacterial Agents; Anti-Inflammatory Agents; Clobetasol; Clone Cells; Diagnosis, Differential; Female; Follow-Up Studies; Gene Rearrangement, T-Lymphocyte; Glucocorticoids; Humans; Isotretinoin; Keratolytic Agents; Lymphocytes; Male; Minocycline; Mucinosis, Follicular; Receptors, Antigen, T-Cell; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Administration, Cutaneous; Central Nervous System; Craniofacial Abnormalities; Female; Fetus; Humans; Keratolytic Agents; Pregnancy; Teratogens; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Anti-Inflammatory Agents; Dermatology; Drug Therapy, Combination; Forecasting; Glucocorticoids; Humans; Isotretinoin; Keratolytic Agents; Prospective Studies; Retinoids; Retrospective Studies; Skin Diseases; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Gels; Humans; Microspheres; Pharmaceutical Vehicles; Treatment Outcome; Tretinoin

Isotretinoin is the most potent human teratogen on the market. Women for whom contraception fails may conceive during or soon after discontinuing isotretinoin therapy, making its elimination kinetics a crucial determinant of fetal safety. The steady-state pharmacokinetics of isotretinoin and its major 4-oxo metabolite were studied in 16 adult patients treated for acne who were receiving doses that ranged from 0.47 to 1.7 mg/kg daily. This is the first study of the pharmacokinetics of isotretinoin in women of childbearing age (n = 11). The clinical efficacy and tolerability of isotretinoin was investigated, and the correlation between these data and steady-state serum concentrations of isotretinoin was tested. The concentration-time data best fitted a two-compartment open model with linear elimination. There was no correlation between efficacy and tolerability of isotretinoin and steady-state serum concentrations. There was no correlation between dose of isotretinoin and steady-state concentration, due to the large variability in apparent clearance. Values for elimination half-life (t1/2) of isotretinoin and its metabolite were 29+/-40 hours and 22+/-10 hours, respectively. These data suggest a longer elimination t1/2 of the parent drug than previously reported. This is probably due to the longer sampling time used in this study (as long as 28 days). This study suggests that a greater variability exists in the safe time after discontinuation of the drug for onset of conception.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Adolescent; Adult; Area Under Curve; Chromatography, High Pressure Liquid; Female; Half-Life; Humans; Isotretinoin; Keratolytic Agents; Male; Pregnancy; Teratogens; Tretinoin

Since acne is a multifactorial skin disease, therapies affecting several etiologic factors can have a higher than expected effectiveness. A combination of the antibiotic clindamycin phosphate and the retinoic acid tretinoin was developed.. Anti-inflammatory and immunomodulatory effects of tretinoin in vitro were studied on human keratinocytes and peripheral blood mononuclear cells (PBMCs). Effects of clindamycin phosphate on tretinoin effects were studied.. Anti-inflammatory effects on keratinocytes were assessed using an in vitro model with PMA (phorbol ester)-stimulated A431 cells (human epidermoid carcinoma). Immunomodulatory effects were measured on superantigen (SEB) stimulated PBMCs.. Tretinoin showed very potent inhibition of PMA-stimulated IL-6 (interleukin 6) release by A431 cells. The addition of clindamycin phosphate did not interfere with this effect. Tretinoin very potently stimulated IL-5 release, and inhibited IFN gamma release by SEB-stimulated human PBMCs. This indicates an immunomodulatory effect, stimulating Th2, and inhibiting Th1 dominated responses. These features have been related to the healing of acne lesions. The addition of clindamycin phosphate did not interfere with the immunomodulatory effects of tretinoin.. The combination of tretinoin and clindamycin phosphate can be expected to be very effective in acne therapy.

Topics: Acne Vulgaris; Adjuvants, Immunologic; Anti-Bacterial Agents; Anti-Inflammatory Agents; Carcinogens; Carcinoma, Squamous Cell; Clindamycin; Humans; Interferon-gamma; Interleukin-5; Interleukin-6; Keratinocytes; Keratolytic Agents; Lymphocytes; Monocytes; Superantigens; Tetradecanoylphorbol Acetate; Th1 Cells; Th2 Cells; Tretinoin

Velac, a new gel formulation containing both tretinoin (0.025%) and clindamycin phosphate (1.2%), is effective in acne vulgaris using a once daily application. The single formulation enhances compliance in young patients and improves the therapeutic results. Treatment with Velac was found to be more effective than tretinoin alone in inflamed lesions and at least comparable in open and closed comedones. In two of the three studies the overall acne severity grade was significantly more reduced when compared with tretinoin. Velac is also more effective than clindamycin alone in the treatment of the non-inflamed lesions. In the two multicentre studies the reduction of the overall acne severity grade was also more favourable for the new gel formulation. A more rapid response occurred with Velac than with either component used (clindamycin or tretinoin) alone.

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Chemistry, Pharmaceutical; Clindamycin; Drug Combinations; Gels; Humans; Keratolytic Agents; Multicenter Studies as Topic; Patient Compliance; Pilot Projects; Randomized Controlled Trials as Topic; Tretinoin

Adapalene, a synthetic retinoid, is a new drug proposed for the treatment of acne patients. Studies on the in vitro and in vivo pharmacology of adapalene have shown that it is very active on cell and tissue proliferation and differentiation. Furthermore, adapalene has anti-inflammatory potential as determined by its anti-AP1 activity. Adapalene interacts selectively with the nuclear receptors RAR beta and RAR gamma, and its activity on proliferation and differentiation can be blocked by a RAR beta-gamma antagonist. Because RAR beta is not expressed in human keratinocytes, the effect of adapalene on the major cell type of the epidermis is certainly mediated by its interaction with RAR gamma. The unique pharmacological properties of adapalene may explain why, when compared to tretinoin, it has an improved therapeutic ratio due to its better tolerance.

Topics: Acne Vulgaris; Adapalene; Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Cell Differentiation; Cell Division; Dermatologic Agents; Drug Interactions; HeLa Cells; Humans; Keratinocytes; Naphthalenes; Receptors, Cytoplasmic and Nuclear; Skin; Tretinoin

Topics: Acne Vulgaris; Drug Therapy, Combination; Humans; Isotretinoin; Keratolytic Agents; Tretinoin

Eleven female patients are reported who underwent full-face resurfacing. Three patients were treated for cosmetic rhytids, five for residual acne scarring, and three for photoaging. There were no complications or side effects in this group of patients. Reepithelialization was achieved in an average of 9.3 days, and erythema disappeared in an average of 8.9 weeks. The UltraPulse carbon dioxide laser with computerized pattern generator (CPG) scanner allows a rapid, uniform laserbrasion. The sequence of the procedure involves close application of adjacent squares at 60 W, 200 to 300 ml, at moderate density. Skin preparation with Retin-A and bleaching agents is important for best wound healing. Postoperative wound care includes maintenance of a moist environment and Zovirax for herpes prophylaxis.

Topics: Acne Vulgaris; Acyclovir; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Antiviral Agents; Carbon Dioxide; Cicatrix; Dexamethasone; Epithelium; Erythema; Facial Dermatoses; Female; Follow-Up Studies; Glycolates; Herpesviridae Infections; Humans; Hydroquinones; Keratolytic Agents; Laser Therapy; Middle Aged; Radiation-Protective Agents; Rhytidoplasty; Skin Aging; Skin Care; Therapy, Computer-Assisted; Tretinoin; Wound Healing

Acne is a family of disorders that vary greatly in pathogenesis and clinical manifestation. Accordingly, no simple recipe for treatment can be given, and treatment options vary with the stage and intensity of the disease. Topical retinoids are the mainstay for treating common varieties of acne vulgaris. They also prevent development of comedones, halting progression to inflammatory lesions. Tretinoin was the first retinoid used in the topical treatment of acne more than 25 years ago. Isotretinoin, which has recently become available, is less irritating, but is probably somewhat less effective. Adapalene is a recently introduced topical retinoid used to treat acne. It enjoys therapeutic equivalence to tretinoin but is less irritating. Except for very mild acne cases, topical retinoids should be used concommitantly with other drugs. The operating principle is to choose drugs whose modes of action are different from topical retinoids, that is, antibiotics or benzoyl peroxide. Topical retinoids, however, constitute the core of nearly all therapeutic programs for acne.

Topics: Acne Vulgaris; Administration, Topical; Humans; Isotretinoin; Keratolytic Agents; Retinoids; Treatment Outcome; Tretinoin

Topics: Acne Vulgaris; Drug Administration Schedule; Female; Humans; Isotretinoin; Male; Tretinoin

A number of serum components, whose concentrations or gene expression have been shown to be modulated by all-trans retinoic acid in vitro, were monitored in patients before and during treatment with Roaccutane (13-cis retinoic acid, 40-60 mg/day) for severe acne. The 13-cis retinoic acid concentration in serum rose from 5.25 +/- 1.09 to 593 +/- 65 nmol/l (mean +/- SD) 24 h after the latest dose. The concentration of all-trans retinoic acid in serum under Roaccutane treatment was measured in model experiments and shown to be 10-20 nmol/l i.e., 2-4 times the basal levels (4.65 +/- 0.85 nmol/l) when the 13-cis retinoic acid concentration was 370-980 nmol/l. The concentrations of creatine kinase-MB, apolipoprotein B, total cholesterol and LDL cholesterol increased significantly while the other measured serum components, including lipoprotein lipase activity, were unaffected by Roaccutane treatment.

Topics: Acne Vulgaris; Adolescent; Adult; Apolipoproteins B; Blood Proteins; Cholesterol; Cholesterol, LDL; Creatine Kinase; Female; Humans; Isoenzymes; Isotretinoin; Lipids; Male; Middle Aged; Tretinoin

The skin of the Mexican hairless dog is covered with comedones, and this animal therefore provides a potentially useful model to assess the comedolytic activity of topical anti-acne drugs. We treated an animal with three different formulations of tretinoin for a 14-week period, and all produced a similar clinical response. There was a striking reduction in the number of comedones, and the skin became lighter and more uniform in colour. Histological changes were similar to those reported in humans treated with tretinoin, but a novel finding was incomplete neogenesis of hair follicles. We suggest that the Mexican hairless dog may be a useful model for screening novel molecules for retinoid activity.

Topics: Acne Vulgaris; Animals; Chemistry, Pharmaceutical; Disease Models, Animal; Dogs; Drug Evaluation, Preclinical; Female; Hair Follicle; Keratolytic Agents; Skin Pigmentation; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adult; Benzoyl Peroxide; Dermatitis, Allergic Contact; Female; Humans; Keratolytic Agents; Male; Patch Tests; Tretinoin

The precise pathologic processes of comedo formation in acne are not well understood. Retention hyperkeratosis may play an important role. To evaluate the effects of three topical comedolytics, 20% azelaic acid, 0.1% tretinoin and 5% benzoyl peroxide, on the retention hyperkeratosis of experimentally induced comedones (EIC), an ultrastructural study was done. After formation of EIC with 50% oleic acid in paraffin oil on the external ears of rabbits, each comedolytic was applied for 4 weeks. Biopsies were taken every week and, using a Hitachi H-600 transmission electron microscope, morphologic observations were done in the upper portion of the follicular epithelium. In EIC, after application of each comedolytic, the markedly thinned horny layer was loosely adhered by extremely few desmosomes and desmosomal bodies. The number and size of tonofilaments and keratohyaline granules decreased, but the number of variable sized Odland bodies increased in the upper epidermis. These findings appeared 1 week after application of either azelaic acid or benzoyl peroxide, and 3 weeks after application of tretinoin. For the first 2 weeks of tretinoin application, EIC showed rather compact hyperkeratosis with more desmosomes and desmosomal bodies than before. Azelaic acid tretinoin and benzoyl peroxide increased the number of Odland bodies, and the horny cells became less adhesive. This lysis of retention hyperkeratosis resulted in comedolysis. During 4 weeks of treatment with these three comedolytics, only tretinoin normalized the keratinization process.

Topics: Acne Vulgaris; Animals; Benzoyl Peroxide; Dermatologic Agents; Dicarboxylic Acids; Disease Models, Animal; Epithelial Cells; Epithelium; Evaluation Studies as Topic; Keratolytic Agents; Keratosis; Rabbits; Tretinoin

Topics: Acne Vulgaris; Adult; Facial Dermatoses; Female; Humans; Keratolytic Agents; Melanosis; Tretinoin

The aim of this study was to investigate the effects of 13-cis retinoic acid treatment on cellular retinoic acid binding protein II (CRABP II) mRNA expression in sebaceous follicles from acne patients, using in situ hybridization. Biopsies were taken from uninvolved skin areas in close juxtaposition to inflamed comedos before therapy, and at 2-4 or 14-16 weeks of treatment. Paraffin sections were used for in situ hybridization study with riboprobes transcribed from human CRABP II cDNA. After oral treatment with 13-cis retinoic acid, sebaceous glands were reduced in size and atrophic, and the ratio of sebum-free to fully differentiated (sebum-producing) sebocytes was dramatically increased. The CRABP II expression in the sebaceous gland, and to some extent in infundibular structures, was strongly increased compared with the level of expression in the epidermis. The maximum signal was always found in layers of suprabasal sebocytes lacking lipid droplets, but never in the basal layers. These findings indicate a selective activity of 13-cis retinoic acid on CRABP II mRNA expression in the sebaceous glands of acne patients.

Topics: Acne Vulgaris; Adolescent; Adult; Female; Humans; In Situ Hybridization; Male; Receptors, Retinoic Acid; RNA, Messenger; Sebaceous Glands; Stereoisomerism; Tretinoin

Topics: Acne Vulgaris; Adult; Dermatitis, Allergic Contact; Drug Eruptions; Facial Dermatoses; Female; Humans; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Humans; Middle Aged; Skin Aging; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Female; Humans; Keratolytic Agents; Male; Middle Aged; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adult; Dermatitis, Allergic Contact; Eczema; Female; Humans; Patch Tests; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Age of Onset; Biopsy; Child; Female; Humans; Keratolytic Agents; Skin; Tretinoin

Topics: Acne Vulgaris; Advertising; Drug Prescriptions; Humans; Newspapers as Topic; Office Visits; Publishing; Skin Aging; Tretinoin

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Humans; Male; Tretinoin

Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Acne Vulgaris; Administration, Topical; Female; Humans; Infant, Newborn; Pregnancy; Pregnancy Complications; Tretinoin

Topics: Acne Vulgaris; Biopsy; Cell Division; Cells, Cultured; Collagen; Fibroblasts; Humans; Keloid; Procollagen; Skin; Tretinoin

Topics: Acne Vulgaris; Burns; Cicatrix; Female; Humans; Self-Injurious Behavior; Tretinoin

Topics: Acne Vulgaris; Black People; Humans; Hyperpigmentation; Tretinoin

Acne vulgaris is a condition commonly treated by primary care physicians. An understanding of the causes of the disease and methods of clinical evaluation allows selection of appropriate therapy. Effective treatment is available for all types of acne, including severe, nodulocystic forms. Regardless of the regimen chosen, patients should receive encouragement and instructions about the necessity of regular ongoing treatment for a successful outcome.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Estrogens; Female; Humans; Isotretinoin; Male; Middle Aged; Tretinoin

We have reported a case of eruptive vellus hair cysts, a rare type of acneiform eruption. Patients with unusual or refractory acneiform eruptions may have any of a variety of non-acne-vulgaris lesions. For this reason, biopsy and culture of these lesions may be helpful in establishing a correct diagnosis and determining proper treatment.

Topics: Acne Vulgaris; Adult; Diagnosis, Differential; Epidermal Cyst; Female; Hair; Humans; Tretinoin

The N-formylmethionyl-leucyl-phenylalanine (f-MLP)-induced metabolic burst activity of peripheral blood neutrophils isolated from acne patients undergoing treatment with 13-cis-retinoic acid at a dose of 1.0 mg/kg/day was investigated using a luminol-enhanced chemiluminescence assay. The mean and median chemiluminescence response were significantly greater (P less than 0.05) in patients receiving 13-cis-retinoic acid than in untreated acne patients or age-matched controls. Pre-incubation of neutrophils with 13-cis-retinoic acid (10 nmol/l) did not affect the chemiluminescence response to formyl peptide. A sequential study over 20 weeks in seven patients demonstrated that chemiluminescence peaked after 2-8 weeks of treatment. In three patients this was accompanied by a worsening of their acne. These studies suggest that, in the initial phase, treatment with 13-cis-retinoic acid may exacerbate, through pro-inflammatory priming of neutrophils, certain neutrophil-mediated inflammatory processes in acne.

Topics: Acne Vulgaris; Adolescent; Adult; Cells, Cultured; Female; Humans; Luminescent Measurements; Male; Methods; N-Formylmethionine Leucyl-Phenylalanine; Neutrophils; Stereoisomerism; Tretinoin

The potential systemic availability of retinoids from topically applied isotretinoin was assessed in 12 men with acne vulgaris. Isotretinoin 0.05% gel was applied to patients at a daily dose of 20 gm (equivalent to 10 mg of isotretinoin) over a 1900 cm2 surface area of skin on the face, back, and chest for 30 days. Blood samples were collected throughout the study and up to 48 hours after the last topical application; they were assayed for isotretinoin, tretinoin, and 4-oxo-isotretinoin by specific high-performance liquid chromatography. Plasma concentrations of isotretinoin, tretinoin, and 4-oxo-isotretinoin were not measurable (less than 20 ng/ml) at any time. Most adverse experiences were cutaneous; a few systemic adverse experiences were judged to be remotely related to topical drug administration. The lack of measurable plasma concentrations of isotretinoin, tretinoin, or 4-oxo-isotretinoin and systemic adverse experiences indicates negligible systemic availability of retinoids even after multiple application of isotretinoin 0.05% gel at doses approximately 12 times greater than normal daily use.

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Chromatography, High Pressure Liquid; Gels; Humans; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Adult; Carotenoids; Humans; Isotretinoin; Lycopene; Retinoids; Tretinoin

Topics: Acne Vulgaris; Adult; Cicatrix; Female; Humans; Skin; Tretinoin

Postmenopausal acne originates at or after menopause in darker-skinned, formerly oily-skinned, large-pored women who usually did not experience adolescent acne. It is a low-grade, long-smoldering acne in which small closed comedones are dominant, among which there is a scattering of dimunitive papulopustules. There is a seeming association with chin and upper lip hirsutism. Topical tretinoin is an effective therapy. Unopposed adrenal androgens present after ovarian failure may be the chief causes of this condition.

Topics: Acne Vulgaris; Female; Humans; Menopause; Tretinoin

In a study of the comedolytic action of retinoids on the epidermal pseudocomedones of rhino mouse skin, the earliest changes and the sequence of events induced by the treatment were investigated. Rhino mice were treated topically with all-trans retinoic acid and at various time intervals from day 0 to 3 weeks, histological and ultrastructural studies as well as quantification of mast cells were performed. The earliest changes occurred in the dermis after 2 days of treatment and were characterized by degranulation of mast cells, clumping and association of Langerhans cells and lymphocytes. During the second week of treatment there was hyperplasia, hypergranulosis and an increase in the number of membrane coating granules with disorganization of the horny layer both of the epidermis and the follicular epithelium. These changes in the proliferation and the differentiation of keratinocytes resulted in a comedolytic effect. Associated with these epidermal changes there were changes in the dermis with an increased number of mast cells and a decreased number of Langerhans cells.

Topics: Acne Vulgaris; Administration, Cutaneous; Animals; Cell Count; Cell Differentiation; Cell Division; Female; Langerhans Cells; Male; Mast Cells; Mice; Microscopy, Electron; Skin; Time Factors; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Erythromycin; Humans; Male; Musculoskeletal Diseases; Radiography; Tretinoin

A rare case of Turcot's syndrome is reported in a long-time survivor of glioblastoma multiforme. The patient was treated for his tumor in 1976 with macroscopically complete surgical resection and radiotherapy consisting of 60 Gy to the tumor bed and 40 Gy to the whole brain. Five years later, in 1981, he developed adenocarcinoma of the colon Dukes Stage B which was successfully treated at another hospital by surgery alone. In 1990, he presented with multiple colon polyps and adenocarcinoma Dukes Stage A. For more than 15 years, the patient has been afflicted with cystic and conglobate acne. Possible mechanisms and treatment with 13-cis retinoic acid are discussed.

Topics: Acne Vulgaris; Adenocarcinoma; Adenomatous Polyposis Coli; Adult; Brain Neoplasms; Glioblastoma; Humans; Male; Neoplasms, Multiple Primary; Syndrome; Time Factors; Tretinoin

The most common disease of the pilosebaceous follicle is acne vulgaris. The primary detectable pathologic defect in acne is abnormal keratinization of the follicular epithelium, resulting in a retention hyperkeratosis. The primary lesion produced by this process, the comedo, ist the precursor of most other acne lesions. These include inflammatory papules, pustules and nodules. Treatment principles are directed against known pathogenic factors. The major topical modalities that are currently being used include tretinoin, benzoyl peroxide and topical antibiotics. Benzoyl peroxide is a powerful antibacterial agent. Topical erythromycin and clindamycin appear to have equivalent efficacy. A major treatment advance has been heralded by the use of oral 13-cis retinoic acid (isotretinoin) in the management of patients with severe nodulocystic acne, acne conglobata and acne fulminans. Isotretinoin is teratogenic and should not be given to women of childbearing age.

Topics: Acne Vulgaris; Adolescent; Adult; Androgen Antagonists; Anti-Bacterial Agents; Anti-Infective Agents, Local; Benzoyl Peroxide; Dermatologic Agents; Humans; Isotretinoin; Tretinoin

A case of pseudo-tumor cerebri is reported in a woman being treated with minocycline and tretinoin for acne who also ingested liver as a self-treatment for her condition. A possible cumulative effect between these agents is postulated.

Topics: Acne Vulgaris; Adult; Female; Humans; Minocycline; Pseudotumor Cerebri; Tretinoin

Topics: Acne Vulgaris; Administration, Cutaneous; Anti-Bacterial Agents; Dermatitis, Seborrheic; Humans; Hydrocortisone; Tretinoin

Isotretinoin differs from acitretin and Ro137410 by its striking sebostatic effect in acne after oral, but not topical, administration. The reason for this is not yet understood. Previous studies indicate that cellular retinoic acid binding protein (CRABP) might be implicated in the action of synthetic retinoids. We, therefore, compared the three retinoids for their ability to increase epidermal CRABP levels after systemic and topical treatment. Oral treatment with acitretin and Ro137410 led to a striking increase of epidermal CRABP (from 2.6 +/- 0.9 to 16.2 +/- 2.9, P less than 0.004 and from 2.5 +/- 1.2 to 21.5 +/- 3.4 pmol/mg protein, P less than 0.004, respectively), while isotretinoin failed to induce a comparable rise (3.2 +/- 1.6 before and 3.7 +/- 0.7 pmol/mg protein after treatment), although it displayed in all patients a striking sebostatic effect. After topical application, the increase of CRABP was comparable for all three compounds. The interaction of isotretinoin with the epidermis seems to be different from other synthetic retinoids only after systemic treatment, a finding that parallels clinical observations.

Topics: Acitretin; Acne Vulgaris; Administration, Oral; Administration, Topical; Adolescent; Adult; Aged; Benzoates; Carrier Proteins; Female; Humans; Isotretinoin; Male; Middle Aged; Receptors, Retinoic Acid; Retinoids; Skin; Time Factors; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Female; Humans; Infant, Newborn; Legislation, Pharmacy; Physician's Role; Physicians, Family; Pregnancy; Tretinoin; United States; United States Food and Drug Administration

The use of isotretinoin over a 2-year period was retrospectively studied in Saskatchewan. The database of the Saskatchewan Prescription Drug Plan was used to obtain the names of physicians who prescribed isotretinoin as well as the names of patients for whom it was prescribed. Of the 861 such patients 161 had been instructed to use the drug for at least 4 months by 42 physicians. Questionnaires were returned by 86 of the 161 patients and 22 of the 42 physicians. The responses confirmed that isotretinoin therapy is highly effective for acne. However, at least half of the patients for whom the agent was prescribed apparently did not complete a full 4- to 5-month course of treatment, and of the 34 women (average age 28 years) who responded to the questionnaire 12 (35%) did not use a method of contraception, which is a matter of concern in view of isotretinoin's teratogenic effects.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Drug Evaluation; Female; Humans; Isotretinoin; Male; Retrospective Studies; Saskatchewan; Surveys and Questionnaires; Teratogens; Tretinoin

Topics: Acne Vulgaris; Adolescent; Agranulocytosis; Humans; Isomerism; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Adult; Graft Survival; Humans; Isotretinoin; Kidney Transplantation; Male; Pancreas Transplantation; Tretinoin

Topics: Acne Vulgaris; Adolescent; Female; Humans; Isotretinoin; Menorrhagia; Tretinoin

Sebaceous glands are stimulated by androgens and can convert them to more active forms. Isotretinoin, however, has a profound inhibitory effect on sebaceous gland size and function. This study evaluated the effect of isotretinoin on serum levels of precursor and tissue-derived androgens. Twenty-four subjects (15 men and nine women) were treated for 20 weeks with 1 mg/kg/d of isotretinoin. Serum samples were obtained at baseline, 8, 16, and 24 weeks, and assayed for precursor androgens--total testosterone (TT), free testosterone (free T), dehydroepiandrosterone (DHEA), dehydroepiandrosterone-sulfate (DHEA-S); and tissue androgens--dihydrotestosterone (DHT), and its metabolite, 3 alpha-androstanediol glucuronide (3 alpha-diol G). Isotretinoin had no meaningful effects on precursor androgens, except for producing an elevation of free T in women. In contrast, isotretinoin produced depressions in the serum levels of DHT and 3 alpha-diol G in women and in 3 alpha-diol G in men. These decreases are believed to be the result, rather than the cause, of a reduction in the size of the sebaceous glands: The magnitude of the observed decreases may represent the amount of tissue-derived androgens that sebaceous glands normally contribute to the circulating pool.

Topics: Acne Vulgaris; Adolescent; Adult; Androgens; Androstane-3,17-diol; Dehydroepiandrosterone; Dehydroepiandrosterone Sulfate; Dihydrotestosterone; Female; Humans; Isotretinoin; Male; Sebaceous Glands; Testosterone; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Female; Humans; Isotretinoin; Legislation, Drug; Pregnancy; Tretinoin; United States; United States Food and Drug Administration

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Drug Therapy, Combination; Female; Humans; Injections, Intramuscular; Isotretinoin; Male; Tretinoin; Vitamin E

In an open design study of fifty-four patients with grade I or grade II acne vulgaris, the combination of 0.1 percent tretinoin cream (Retin-A) and a sunscreen with sun protection factor 15 (Sundown) was evaluated. Overall study results of the forty-six patients who could be evaluated demonstrated a decrease in papule count of 25.9 percent, a decrease in closed comedones of 49.1 percent, and a decrease in open comedones of 36.3 percent by the end of the eight-week study period. These results indicate that the addition of a noncomedogenic sunscreen to tretinoin did not compromise its effectiveness and successfully prevented photoaccentuation reactions.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Photosensitivity Disorders; Sunscreening Agents; Tretinoin

Topics: Acne Vulgaris; Chemotaxis, Leukocyte; Depression, Chemical; Humans; Isotretinoin; Neutrophils; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Female; Humans; Isotretinoin; Pregnancy; Pregnancy Complications; Tretinoin; United States; United States Food and Drug Administration

The use of isotretinoin in therapeutical dermatology has proved to be of great benefit in a series of cutaneous processes, especially in cystic and conglobate acne, where it produces excellent results with a dose of 1 mg/kg/daily. However, its use is not without complications, the majority of which are well known, and doubtlessly others will be brought to light. As for a case of pseudoacne fulminans, the possible etiopathogenic mechanisms of this type of reaction, are under discussion.

Topics: Acne Vulgaris; Acute Disease; Adolescent; Humans; Isotretinoin; Male; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Adolescent; Adult; Female; Humans; Isotretinoin; Pregnancy; Pregnancy Complications; Tretinoin

We evaluated the effects of long- and short-term isotretinoin therapy on the skeletons of patients. Eight patients who were treated with isotretinoin for disorders of keratinization received frequent radiographic evaluations for 4 to 9 years. Seven patients developed multiple hyperostoses at the spine and extremities. Hyperostoses increased in size and number over the course of therapy, although relatively few sites were symptomatic. Hyperostoses typically developed first in the spine and later in the extremities, where both bilaterally symmetric and asymmetric involvement was observed. After 5 years of therapy one patient did not develop hyperostosis. In a group of nine patients who received a relatively high dose of isotretinoin in 1982 for the treatment of acne, two patients developed tiny, asymptomatic hyperostoses. One patient had hyperostoses 1 year after isotretinoin therapy, which remained unchanged 3 years later, whereas the other patient had one hyperostosis 4 years after therapy had been stopped. Although we suspect that these hyperostoses were retinoid induced, they should not be of concern for the patient needing routine isotretinoin therapy for the treatment of cystic acne.

Topics: Acne Vulgaris; Adolescent; Adult; Bone Diseases; Child; Female; Follow-Up Studies; Humans; Ichthyosis; Isomerism; Isotretinoin; Male; Radiography; Skin Diseases; Spinal Diseases; Time Factors; Tretinoin

One of the primary events in the pathogenesis of acne vulgaris is abnormal follicular keratinization. Since oral isotretinoin therapy reduces follicular hyperkeratinization in acne, our study has been designed to determine whether epidermal lipid composition of the epithelium of sebaceous follicles is affected by isotretinoin treatment. Noninflamed early comedones obtained from ten patients with nodulocystic acne before and after the 6th week of isotretinoin therapy (mean daily dose 0.7 mg/kg b. wt.) were used as probes of the hyperkeratinizing follicular epithelium. Comedonal lipids were analyzed by high-performance thin-layer chromatography. Oral isotretinoin caused a decrease of the comedonal glyceride fraction by 36% (P less than 0.01), whereas free sterols and total ceramides increased by 34% (P less than 0.10) and 19%, respectively. The changes of comedonal lipids were associated with a significant elevation of the free sterols/cholesterol sulfate ratio of 86% from pretreatment levels (P less than 0.05). The isotretinoin-induced changes of the comedonal lipid composition in direction to a pattern of epidermal lipids of normal desquamating stratum corneum are discussed as a possible comedolytic mechanism of oral isotretinoin treatment.

Topics: Acne Vulgaris; Adult; Ceramides; Cholesterol Esters; Dermatologic Agents; Female; Humans; Isotretinoin; Lipid Metabolism; Male; Sebaceous Glands; Sterols; Tretinoin; Triglycerides

We report the observation of delayed wound healing and keloid formation in three patients, following dermabrasion or Argon laser treatment administered while they were receiving isotretinoin for acne or rosacea.

Topics: Acne Vulgaris; Adult; Aged; Dermabrasion; Female; Humans; Isomerism; Isotretinoin; Keloid; Laser Therapy; Male; Rosacea; Tretinoin; Wound Healing

Topics: Acne Vulgaris; Adolescent; Agranulocytosis; Humans; Isotretinoin; Male; Neutropenia; Recurrence; Tretinoin

Vitamin A acid is the most effective comedolytic agent in the therapy of acne vulgaris. Antibiotics are suitable for the treatment of inflammatory lesions (papulo-pustules). Even topically applied, some antibiotics show a sufficient anti-inflammatory effect. Above all, erythromycin is reliable in the topical treatment of acne. Combined therapy with both topical tretinoin and erythromycin is more effective than either alone. During the first weeks of treatment, tretinoin leads to temporary deterioration of the disease, which can mostly be avoided by the anti-inflammatory effect of erythromycin simultaneously applied.

Topics: Acne Vulgaris; Administration, Topical; Drug Therapy, Combination; Erythromycin; Follow-Up Studies; Humans; Tretinoin

Topics: Acne Vulgaris; Adult; Female; Humans; Skin; Tretinoin

Topics: Acne Vulgaris; Etretinate; Humans; Isotretinoin; Keratins; Papillon-Lefevre Disease; Skin Diseases; Tretinoin

Eleven acne patients were treated with isotretinoin for 3-7 months. The water barrier function and the response of sweat glands to dilute methacholine injections were examined on upper back skin at onset and at several visits during therapy. Bilaterally located test sites representing healthy skin or skin sites which were least affected by acne lesions were selected for the study. The same sites were used at each visit for assessing the parameters. Although skin dryness was a common finding on the face and arms, no significant changes in baseline water loss (BWL) rates were found on the back skin during isotretinoin treatment. Instead there was a significant increase in the sweat gland responsiveness to methacholine during isotretinoin treatment as measured by the evaporimetric technique. Furthermore, in four out of five patients the numbers of active sweat glands, counted in plastic imprints from the stimulated test sites, showed a similar increase during therapy when compared to pretreatment values.

Topics: Acne Vulgaris; Adolescent; Adult; Epidermis; Female; Humans; Isotretinoin; Male; Sweat Glands; Sweating; Tretinoin

Isotretinoin is of undisputed benefit in the treatment of acne. In doses of 1 mg/kg/day for 4 months the drug produces a highly significant reduction in sebum excretion rate (90 +/- 3%) in comedone formation as measured by assessing follicular casts (70 +/- 5%), and in surface Propionibacterium acnes. However, the mechanisms of long-term clinical remission are not well understood. There are however, risk factors which predetermine the outcome to treatment with isotretinoin. Younger subjects (14-19 years) and those who have had acne for less than 6 years, respond less well than older subjects. Subjects with more truncal acne also fare less well than those with predominantly facial acne. A return of the reduced sebum excretion rate to within 10% of the pre-treatment level also is a poor prognostic factor. This and future studies could lead to development of more logical dose regimes depending, for example, on the age of the patient; duration of acne and its site. However, until proven otherwise, this study confirms our earlier data, and that of the German multi-centres and Strauss et al (1), that the optimum dose schedule for treating acne patients is 1 mg/kg/day regime.

Topics: Acne Vulgaris; Adolescent; Adult; Follow-Up Studies; Humans; Isotretinoin; Keratins; Microbial Sensitivity Tests; Prognosis; Propionibacterium acnes; Tretinoin

We present two patients, a 20-year-old female and an 18-year-old male, who suffered from persistent solid facial edema as a complication of acne vulgaris. They were treated with isotretinoin with moderate response and thereafter with lymph massage with further response. The female patient also received clofazimine with good response.

Topics: Acne Vulgaris; Adolescent; Adult; Clofazimine; Dermatologic Agents; Edema; Face; Female; Humans; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Cataract; Humans; Isotretinoin; Male; Middle Aged; Tretinoin

Topics: Acne Vulgaris; Adult; Agranulocytosis; Humans; Isotretinoin; Leukopenia; Male; Neutropenia; Time Factors; Tretinoin

Topics: Acne Vulgaris; Drug Eruptions; Eczema; Humans; Isotretinoin; Tretinoin

Isotretinoin (13-cis-retinoic acid) is used in the treatment of severe cystic acne. Adverse ocular reactions, including blepharoconjunctivitis and dry eye symptoms, are frequent side effects of this drug. Our previous observation that retinol is present in tears and lacrimal gland fluid suggests that isotretinoin may also be secreted by the lacrimal gland. Rabbits were treated with isotretinoin, and lacrimal gland fluid was collected from the cannulated lacrimal gland duct. Tears were collected from patients who were being treated with isotretinoin. Lacrimal gland fluid and tears were analyzed by reverse-phase high-pressure liquid chromatography and a peak eluted from each sample, which was identified as isotretinoin. We conclude that the lacrimal gland is able to secrete isotretinoin in addition to retinol and that, in animals and patients treated systemically with isotretinoin, the ocular surface is exposed to the drug via the tear film.

Topics: Acne Vulgaris; Adult; Animals; Chromatography, High Pressure Liquid; Female; Humans; Isomerism; Isotretinoin; Lacrimal Apparatus; Male; Rabbits; Tears; Time Factors; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Child, Preschool; Humans; Infant; Tretinoin

In summary, the therapy of acne has to be individualized according to the nature of the lesions. Noninflammatory acne requires a different therapeutic approach from that for inflammatory acne, and even among those with inflammatory acne, there can be a difference in the therapeutic approach, depending upon the extent of involvement. Attention to the principles of therapy will be a great aid in the success of the therapeutic program for acne.

Topics: Acne Vulgaris; Adrenal Cortex Hormones; Anti-Bacterial Agents; Benzoyl Peroxide; Estrogens; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Adult; Humans; Isotretinoin; Kidney Transplantation; Male; Tretinoin

Topics: Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide; Dermatologic Agents; Humans; Patient Education as Topic; Peroxides; Tretinoin

Treatment with retinoids results in increased serum triglyceride and cholesterol and reduced HDL-cholesterol; dietary supplementation with fish oil lowers serum lipids. Therefore combining retinoids with fish oil may reduce retinoid hyperlipidaemia. Increased triglyceride due to isotretinoin was reduced by 70% (P less than 0.05) and cholesterol by 45% (P less than 0.05) after addition of fish oil; placebo oil had no effect. These decreases were not associated with changes in levels of HDL-cholesterol or reduction of increased levels of apoprotein B. Increased triglyceride due to etretinate was reversed after the addition of fish oil (P less than 0.01), but cholesterol levels did not change. Therefore fish oil inhibits hypertriglyceridaemia due to isotretinoin and etretinate and reduces increased cholesterol levels due to isotretinoin; this effect is likely to be due to altered lipoprotein composition.

Topics: Acne Vulgaris; Adolescent; Adult; Aged; Cholesterol; Etretinate; Female; Fish Oils; Humans; Hyperlipidemias; Isotretinoin; Male; Middle Aged; Psoriasis; Tretinoin; Triglycerides

The effect of oral isotretinoin (13-cis-retinoic acid) on in vivo chemotactic responses was studied longitudinally in 7 patients with cystic acne. As measured in a microchamber chemotaxis assay, both monocyte and neutrophil chemotaxis were inhibited 98% (p less than 0.001) during isotretinoin treatment. In vivo chemotactic responses returned to normal within 2 months of cessation of treatment. Biopsies of skin chamber sites from patients on isotretinoin showed no significant dermal or epidermal leukocytic accumulation in response to autologous zymosan-activated serum, whereas chambers from controls showed extensive neutrophilic infiltrates even in the epidermis. In contrast, in vitro chemotactic responses of neutrophils and monocytes from patients on isotretinoin were not diminished. Sera and plasma from patients on isotretinoin contained no inhibitors of chemotaxis, and activated sera from these patients were excellent attractants for normal monocytes. We postulate that isotretinoin produces significant anti-inflammatory effects by inhibition of monocyte and neutrophil chemotaxis across intact biologic barriers in vivo.

Topics: Acne Vulgaris; Chemotaxis; Chemotaxis, Leukocyte; Cysts; Humans; Isotretinoin; Monocytes; Neutrophils; Skin Diseases; Tretinoin

A case of excess granulation tissues in a patient treated with isotretinoin by a severe cystic acne is reported. Other cases described in the literature are reviewed.

Topics: Acne Vulgaris; Adolescent; Granulation Tissue; Granuloma; Humans; Isotretinoin; Male; Skin Diseases; Tretinoin

Vitamin A and vitamin A derivatives have been described as etiologic factors for a number of congenital malformations. Two infants are presented with major auricular malformations including anotia and severe microtia. The infants were products of a pregnancy complicated by Accutane ingestion during the first trimester. Both infants had associated central nervous system malformations. With the increasing use of Accutane for the treatment of cystic acne in young women of child-bearing age, the dangers of teratogenesis in the head and neck area are greatly increased. This presentation will review two such cases as well as give an overview of the embryogenesis and teratogenesis of the auricle.

Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Acne Vulgaris; Adult; Ear, External; Female; Humans; Infant, Newborn; Isotretinoin; Male; Teratogens; Tretinoin

Topical tretinoin has been used for a number of years to treat patients with acne vulgaris. This paper reviews some of the newer uses of tretinoin, including treatment of patients with photoaging of the skin, premalignant lesions, dry-eye disorders, and its use after dermabrasion.

Topics: Acne Vulgaris; Administration, Topical; Dermabrasion; Humans; Photosensitivity Disorders; Precancerous Conditions; Skin Neoplasms; Tretinoin; Wound Healing; Xerophthalmia

Topics: Acne Vulgaris; Adolescent; Granulation Tissue; Humans; Hypertrophy; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Female; Humans; Isotretinoin; Pregnancy; Teratogens; Tretinoin

Thirteen patients with severe acne were treated for 16 weeks with 1.0 mg/kg/day isotretinoin. There were significant increases in serum cholesterol (P less than 0.02), triglycerides (P less than 0.02) and apolipoprotein B (P less than 0.02). No changes were found in serum apolipoprotein A-1, non-esterified fatty acids (NEFA), carnitine, lactate, pyruvate, glycerol, alanine, beta-hydroxybutyrate, glucose or insulin. We therefore found no evidence that the hyperlipidaemia of isotretinoin therapy is due to increased fluxes of NEFA from adipose tissue to the liver, although we cannot exclude the possibility that there are changes in the proportion of NEFA being esterified to triglyceride or undergoing beta-oxidation. We suggest that the hyperlipidaemia induced by isotretinoin may be due to an increase in circulating lipoprotein from increased production or impaired catabolism.

Topics: Acne Vulgaris; Adolescent; Adult; Apolipoproteins; Blood Glucose; Carnitine; Fatty Acids, Nonesterified; Female; Humans; Insulin; Isotretinoin; Lipids; Male; Tretinoin

Oral isotretinoin has been reported to increase serum total triglycerides (TG), cholesterol (TC), phospholipids (TPL), apoprotein B (apo B), and to reduce high-density lipoprotein cholesterol (HDL-C). To investigate the effects of isotretinoin on HDL, we measured HDL-C, HDL phospholipids (HDL-PL), apoprotein A1 (apo A-1), and HDL-C subfractions (HDL2-C and HDL3-C) in 24 healthy, male patients receiving a 16-week course of isotretinoin (1.0 mg/kg/day) for treatment of severe acne vulgaris. Patients were placed on a constant diet and fasting lipid parameters were measured every 4 weeks. Analysis of the data from the 20 patients who completed the study confirmed the reported increase in TG, TC, LDL-C, apo B, and LDL-C/HDL-C (all p less than 0.01) observed during isotretinoin therapy. Reduction occurred in HDL-C (p less than 0.05) and HDL2-C (p less than 0.01) while HDL3-C remained unchanged, indicating that the effect of isotretinoin is on the HDL2-C subfraction. Apo A-1 and HDL-PL did not change significantly, suggesting that the reduction in HDL-C represents cholesterol depletion of the HDL particle rather than a reduction in HDL mass. After discontinuing isotretinoin, serum lipid parameters returned to baseline levels.

Topics: Acne Vulgaris; Adolescent; Adult; Cholesterol, HDL; Humans; Isotretinoin; Lipoproteins; Lipoproteins, HDL; Male; Tretinoin; Triglycerides

Using the sebum-absorbent tape technique, we have disclosed five different patterns of follicular sebum excretion rate (SER). These are the infantile, pubertal, acne, adult and aging patterns, distinguished by different densities of active sebaceous follicles, by distinct levels of follicular SER and by the relative stability in time of the overall SER.

Topics: Acne Vulgaris; Adolescent; Adult; Aged; Aged, 80 and over; Aging; Benzoyl Peroxide; Child; Child, Preschool; Cytodiagnosis; Hair; Humans; Image Processing, Computer-Assisted; Infant; Isotretinoin; Middle Aged; Sebaceous Glands; Sebum; Skin Diseases; Tretinoin

A new approach studying the characteristics of the stratum corneum is presented: the electrophoretic mobility of corneocytes by laser Doppler spectroscopy. The detergent scrub technique was used for harvesting corneocytes from three body regions (forehead, palm, and sole) of normal persons (n = 20) under casual conditions and after thorough defattening of the skin with 70% isopropyl alcohol or petrol. Similarly, cells from the forehead, shoulder, and palm were obtained from 22 acne patients treated with isotretinoin (13-cis retinoic acid) 0.5-0.7 mg/kg body weight (b.wt.)/day for 12-16 weeks, and in patients receiving arotinoid (Ro 15-0778) 192 mg (n = 5) or 500 mg (n = 5) per kg/b.wt./day for 6 weeks (forehead and shoulder). In another experiment, cell suspensions with a pH ranging from 5.0-7.3 were evaluated. Measurements were performed by dynamic laser light scattering. This laser application allows exact electrophoretic mobility measurements in a short time (3 min). When cells pass the laser beam, the scattered light is frequency-shifted due to the optical Doppler effect. These frequency shifts are analyzed by the heterodyne light beating technique. The analog signal of the photodetector is converted into a power spectrum by Fourier analysis. This power spectrum represents the spectrum of electrophoretic cell mobility distribution. Results showed different electrophoretic mobility values for corneocytes dependent on the topographic region: forehead 1.18 +/- 0.16, palm 1.10 +/- 0.14, and sole 0.83 +/- 0.10 (means +/- SEM) micron cm/Vs. Defattening with isopropyl alcohol decreased the mobility values to 0.90 +/- 0.09 (p less than or equal to 0.01), 0.95 +/- 0.10, and 0.77 +/- 0.10 micron cm/Vs respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acne Vulgaris; Adolescent; Adult; Epidermis; Female; Humans; Isotretinoin; Male; Retinoids; Rheology; Sebaceous Glands; Tetrahydronaphthalenes; Tretinoin

A selected group of 60 patients who had been resistant to previous systemic antibiotic therapy was treated with low-dose isotretinoin (0.5 mg/kg/day in two doses) for 12 to 20 weeks. The results confirmed the efficacy of the drug on pustular, nodular and cystic acne even with low-dose treatment. In only one case was it necessary to suspend the treatment because of an increase in serum cholesterol and triglycerides. The authors therefore advise the use of low dosage and that treatment should be restricted to cases of severe acne.

Topics: Acne Vulgaris; Adolescent; Adult; Dose-Response Relationship, Drug; Follow-Up Studies; Humans; Isotretinoin; Male; Tretinoin

Follicular and sebaceous gland cell differentiation was investigated during treatment of acne patients with isotretinoin. Sebaceous glands were significantly reduced in volume and showed decreased metabolic activity as measured by glucose-6-phosphate dehydrogenase and succinic dehydrogenase enzyme activities. There was no measurable change in the volume of follicular duct epithelium or in its metabolic activity during treatment. Metabolic activity was also unchanged in the interfollicular epidermis, contrasting with the effects of another retinoid, etretinate. These findings provide no support for the proposition that alteration in the process of follicular keratinization forms a substantial part of the mode of action of isotretinoin.

Topics: Acne Vulgaris; Cell Differentiation; Esterases; Female; Glucose Dehydrogenases; Humans; Isotretinoin; Male; Sebaceous Glands; Succinate Dehydrogenase; Time Factors; Tretinoin

Topics: Acne Vulgaris; Adolescent; Humans; Isotretinoin; Platelet Count; Thrombocytopenia; Tretinoin

Topics: Acne Vulgaris; Benzoyl Peroxide; Humans; Tretinoin

Apoprotein, lipoprotein and lipid parameters of 36 normolipidemic subjects (23 males, mean age 22.7 +/- 7.6 years; 13 females, mean age 26.2 +/- 9.8 years) receiving oral isotretinoin (mean daily dose 0.73 +/- 0.26 mg/kg body weight) for nodulocystic acne (n = 18), severe acne papulopustulosa (n = 15), gram-negative folliculitis (n = 2) and papulopustular rosacea (n = 1) were monitored before and during isotretinoin therapy at biweekly intervals over a period of 14.6 +/- 5.6 weeks. Pretreatment values of mean plasma triglycerides increased significantly (p less than 0.001) from 81.8 +/- 31.9 mg/dl to 112.4 +/- 38.7 mg/dl (47.4%) during isotretinoin treatment. With respect to the mean percent increase of plasma triglycerides from pretreatment levels, patients were classified as nonresponders (less than 10% triglyceride increase), responders (greater than 10% less than 50% triglyceride increase) and hyperresponders (greater than 50% triglyceride increase), revealing a distribution of 25.0, 36.1 and 38.9%, respectively. Isotretinoin treatment had no influence on the isoelectric focusing pattern of apoprotein E isoforms and C apoproteins. In particular, apoprotein C-II, the cofactor of lipoprotein lipase, was not affected. No correlation between apoprotein E phenotypes (2/3, 3/3, 3/4) and the mean plasma triglyceride increase could be demonstrated. Apoprotein B-48, a marker of chylomicrons and atherogenic chylomicron remnants, could not be detected by SDS-PAGE. On the other hand in 21.0% of patients with preexisting mean lipoprotein Lp(a) levels of 18.1 +/- 12.9 mg/dl a moderate increase of atherogenic Lp(a) to mean levels of 37.0 +/- 22.0 mg/dl was observed. Pretreatment values of very-low-density lipoprotein (VLDL) apoprotein (apo) B (7.5 +/- 2.0 mg/dl), low-density lipoprotein apo B (67.3 +/- 17.5 mg/dl) and total plasma apo B (76.6 +/- 19.0 mg/dl) increased significantly to levels of 10.3 +/- 2.4 mg/dl (p less than 0.001), 75.7 +/- 15.8 mg/dl (p less than 0.10) and 85.9 +/- 17.7 mg/dl (p less than 0.05), respectively. As lipoprotein lipase and hepatic lipase activities have been shown to be unaffected by isotretinoin treatment, our data support the hypothesis that isotretinoin induces hepatic oversecretion of VLDL, a condition resembling type IV hyperlipidemia in diabetics, familial hypertriglyceridemia of familial combined hyperlipidemia.

Topics: Acne Vulgaris; Adult; Apolipoproteins; Female; Humans; Isotretinoin; Lipids; Lipoproteins; Male; Phenotype; Tretinoin; Triglycerides

Topics: Acne Vulgaris; Adenocarcinoma; Colonic Neoplasms; Humans; Hypertrichosis; Isotretinoin; Male; Middle Aged; Paraneoplastic Syndromes; Tretinoin

Topics: Acne Vulgaris; Adult; Cicatrix; Drug Administration Schedule; Female; Humans; Tretinoin

The beneficial effects of isotretinoin (Accutane) on severe nodulocystic acne and significant clinical improvement with prolonged remission are well documented in the literature; however, the subjects in these clinical studies are invariably white. The purpose of this study was to evaluate the response of black patients with recalcitrant nodulocystic acne to isotretinoin treatment. Ten black patients, ranging in age from 17 to 34 years, were treated for nodulocystic acne with 1 mg/kg/d of isotretinoin for 20 weeks and followed for an additional six months. Of the ten patients, eight adhered to the treatment regimen and were still in remission six months after completion of isotretinoin therapy. The differences and similarities seen between black patients and white patients with nodulocystic acne are discussed.

Topics: Acne Vulgaris; Adolescent; Adult; Black People; Cysts; Female; Humans; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Adult; Female; Gingival Hypertrophy; Humans; Isotretinoin; Phenytoin; Tretinoin

Topics: Acne Vulgaris; Biopsy; Humans; Isotretinoin; Receptors, Androgen; Sebaceous Glands; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Androgen Antagonists; Anti-Bacterial Agents; Benzoyl Peroxide; Bifidobacterium; Female; Humans; Intestines; Lactobacillus acidophilus; Male; Tretinoin

Topics: Acne Vulgaris; Adult; Female; Humans; Lithium; Tretinoin

Skeletal abnormalities have been reported on numerous occasions in patients who have received high doses of vitamin A and its derivatives. Recently, a new derivative, isotretinoin (Accutane, Hoffman-LaRoche, Inc.), has become available for the treatment of cystic acne. Ninety-six patients treated for a minimum of four months with low doses of this drug at two University centers have shown overall good to excellent clinical responses. However, ten of these patients have developed small pointed excrescences on the anterior margins of cervical, thoracic, or lumbar vertebral bodies. The findings are of unknown clinical significance but show some similarities to the spinal findings in DISH syndrome. Follow-up studies will be obtained, but, at the present time, the drug still can be recommended for patients who have severe cystic acne because of the excellent clinical response.

Topics: Acne Vulgaris; Adolescent; Adult; Exostoses; Female; Humans; Isotretinoin; Male; Radiography; Spinal Diseases; Tretinoin

Four weeks after the introduction of a therapeutic regimen with 80 mg 13-cis-retinoic acid/day, a 16-year-old male patient developed oozing hypergranulation with vulnerable masses within acne lesions. These local symptoms were accompanied by fever, fatigue, weight loss, polyarthralgia and myalgia, similar to acne fulminans. In spite of these unusual reactions treatment was continued. Local steroid ointments were additionally applied. Within a short period of time regression of granulations and normalization of the general health condition was observed. After 4 months, therapy was discontinued. The patient's acne had totally healed and did not relapse within an observation period of 2 years.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Granulation Tissue; Granuloma; Humans; Isotretinoin; Male; Skin Diseases; Tretinoin; Wound Healing

Topics: Acne Vulgaris; Dark Adaptation; Humans; Isomerism; Isotretinoin; Tretinoin; Vision, Ocular

Topics: Acne Vulgaris; Adolescent; Cyclophosphamide; Granulomatosis with Polyangiitis; Humans; Isotretinoin; Lung; Male; Necrosis; Prednisone; Skin; Skin Ulcer; Tretinoin

Topics: Acne Vulgaris; False Negative Reactions; Humans; Isotretinoin; Male; Thyroid Function Tests; Thyrotropin; Thyroxine; Tretinoin; Triiodothyronine

89 patients (66 males and 23 females) with severe acne were treated with isotretinoin and were followed up for a period of 6-47 months (mean 14 months) after the end of the therapy. Relapses occurred in 14.6% of the patients. They were not found to be related to the total amount of isotretinoin administered (up to 233 mg/kg); a possible, although not significant, link to sex was observed since relapses occurred in 16.6% males and 8.6% of females. But the age of the patients had a significant bearing on the likelihood of relapses: younger patients relapsed more frequently than older patients.

Topics: Acne Vulgaris; Adolescent; Adult; Age Factors; Female; Follow-Up Studies; Humans; Isotretinoin; Male; Recurrence; Sex Factors; Time Factors; Tretinoin

Excessive, pseudotumoral granulation tissue proliferations appeared in three patients receiving isotretinoin for nodulocystic acne. A review of the literature disclosed few reports of this unusual adverse reaction. Two clinical patterns have been reported; one in a periungual location and the other occurring in the sites of acne lesions during isotretinoin therapy. Loose edematous connective tissue with small vessels and chronic inflammatory infiltrate were the histologic findings in all three cases.

Topics: Acne Vulgaris; Adolescent; Adult; Connective Tissue; Granulation Tissue; Humans; Isomerism; Isotretinoin; Male; Skin; Tretinoin

Fifteen patients with acne and 4 with rosacea were treated topically with 0.2% isotretinoin cream twice a day for 16 weeks. Inflammatory lesions responded better (30 +/- 22 versus 15 +/- 12) than non-inflammatory lesions (23 +/- 44 versus 17 +/- 24). Neither the "causal level" (123 +/- 85 versus 130 +/- 66 micrograms/cm2 nor the "replacement sum" (70 +/- 29 versus 77 +/- 30 micrograms/cm2) were changed (lipometer assay). In 150 adult male Syrian hamsters 1-2 drops of isotretinoin in concentrations varying from 0.3% to 0.001% and arotinoid ranging in concentration from 0.3% to 0.00001% in acetone were applied to the left ventral ear or the left flank organ twice a day (5/7 days) for 21 days. In higher concentrations there was a significant reduction in sebaceous gland size. Arotinoid, however, is extremely toxic. Even in concentrations as low as 0.00001% the animals showed severe side-effects within the 1st week.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Animals; Benzoates; Cricetinae; Dose-Response Relationship, Drug; Female; Humans; Isotretinoin; Male; Mesocricetus; Retinoids; Rosacea; Sebaceous Glands; Tretinoin

Topics: Abnormalities, Drug-Induced; Abortion, Induced; Acne Vulgaris; Ethics, Medical; Female; Humans; Isotretinoin; Pregnancy; Tretinoin

Regarding treatment of acne vulgaris and rosacea, there is not much difference between hospital and practice nor among practicing dermatologists. Most of the assistants performing the important physical-manual treatment have had the same training. After analytical conversation and etiologic as well as diagnostic classification, the patients undergo the following manual treatment: cleansing, astringing, removing of comedones, massage, face pack, and covering with tinted emulsion. At home, acne: cleansing, massage, skin lotion, vitamin A acid, benzoylperoxide, antibacterial therapy; in serious male cases of acne conglobata, Roaccutan. Rosacea: antiseptic (antibiotic) treatment (topically and systemically), metronidazole (Arilin); in serious male cases, Roaccutan.

Topics: Acne Vulgaris; Benzoyl Peroxide; Combined Modality Therapy; Erythromycin; Feeding Behavior; Humans; Rosacea; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Adult; Female; Humans; Isomerism; Isotretinoin; Proctitis; Tretinoin

16 patients suffering from acne conglobata were prospectively examined by means of analytical interviews and 5 psychometric procedures before and 6 months after oral treatment with 13-cis retinoic acid (isotretinoin). In comparison with a control group of psychosomatic patients, acne conglobata patients are more frequently affected by childhood influences leading to a neurotic personality structure already before the outbreak of acne; the patients more often complain of disturbed social contact, depressive moods, or general disorders. After successful treatment with isotretinoin, we observed augmented self-confidence and positive aggressiveness, on one hand, and increase of anxiety depressive moods, and general complaints, on the other. These effects are not drug related in a pharmacological way. These observations suggest the influence of psychic factors in the pathogenesis of acne conglobata. Regarding the medical management of these patients, it should be considered that psychic and psychosomatic disorders might be intensified after successful drug therapy.

Topics: Acne Vulgaris; Adaptation, Psychological; Adolescent; Adult; Female; Follow-Up Studies; Humans; Isotretinoin; Male; Neurotic Disorders; Parent-Child Relations; Personality Development; Personality Tests; Psychophysiologic Disorders; Tretinoin

Following 20 weeks of treatment with isotretinoin, sebaceous glands in patients with cystic acne shrank in size. The cells remaining in the sebaceous lobules were mainly mature lipid-filled cells, with some undifferentiated cells still present at the periphery. The ultrastructure of the glands 8 weeks after cessation of treatment was directly related to the drug dose given each patient. The larger the dose, the slower the return to pretreatment morphology. In those patients given a lower dose, most of the glands observed 2 months after treatment was stopped were similar in size to those seen prior to treatment.

Topics: Acne Vulgaris; Cell Differentiation; Cysts; Dose-Response Relationship, Drug; Humans; Isotretinoin; Sebaceous Glands; Tretinoin

Three of 50 patients treated with isotretinoin (1 mg/kg/day) for cystic acne complained of poor night vision and/or excessive glare sensitivity. While still receiving the drug or shortly thereafter, two patients were found to have abnormal dark-adaptation curves, with elevations of either cone or rod thresholds, or both. Two patients had abnormal electroretinograms (ERGs). One had a mildly abnormal electro-oculogram. The dark-adaptation curves were normal for one patient several months after isotretinoin therapy was discontinued. Two patients had elevated cone thresholds at least one year later. Six months following cessation of therapy, the ERG was still abnormal for one patient, but continued improvement was evident at 25 months; for the second patient, the ERG was normal at one year. Analysis of Naka-Rushton parameters for the ERG scotopic b-wave stimulus-response curves indicated response compression for two patients, as evidenced by a reduction in the maximum response. For one patient, the half-saturation constant was elevated 0.7 log units, suggesting reduction of retinal sensitivity, perhaps from decrease in retinal photopigment concentration. We suspect that isotretinoin may complete for normal retinol binding sites on cell surfaces or transport molecules. A prospective study is currently underway to determine if a clinically measurable adverse effect on retinal function is seen with greater frequency.

Topics: Acne Vulgaris; Adolescent; Adult; Dark Adaptation; Electrooculography; Electroretinography; Follow-Up Studies; Humans; Isotretinoin; Male; Retina; Time Factors; Tretinoin; Vision, Ocular

Topics: Acne Vulgaris; Adolescent; Adult; Female; Humans; Isotretinoin; Male; Photosensitivity Disorders; Time Factors; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Cholesterol, HDL; Female; Humans; Isotretinoin; Lipids; Lipoproteins; Liver; Male; Risk; Tretinoin

Retinoids are natural and synthetic analogues of vitamin A. They have a marked influence on the differentiation of epithelial tissues by modifying membrane glycoconjugates and by acting through cytosolic and nuclear mechanisms like steroid hormones. Their clinical and biological toxic effects are numerous, but they are usually benign and reversible. However the possibility of teratogenic effects requires close monitoring of female patients. Etretinate is particularly effective in disorders of keratinisation (psoriasis, ichthyosis) whereas isotretinoin is the best known therapy of severe acne. Moreover the possible role of retinoids in the prevention and treatment of certain cancers gives hopeful prospects.

Topics: Acne Vulgaris; Chemical Phenomena; Chemistry; Etretinate; Humans; Ichthyosis; Isotretinoin; Neoplasms; Psoriasis; PUVA Therapy; Recurrence; Retinoids; Tretinoin

Topics: Acne Vulgaris; Adolescent; Female; Humans; Isotretinoin; Teratogens; Tetracycline; Tretinoin

This paper reports on the association of two uncommon side effects of isotretinoin therapy for cystic acne: paronychia and excess granulation tissue in the nail sulci. An explanation for these side effects is suggested, but the exact pathogenesis remains obscure.

Topics: Acne Vulgaris; Adult; Female; Granuloma; Humans; Isotretinoin; Nail Diseases; Paronychia; Tretinoin

A case of persistent solid facial edema is described in a 17-year-old boy with moderate papulocystic acne. After a 20-week course of isotretinoin, the acne vulgaris resolved, and there was a moderate reduction in the facial edema.

Topics: Acne Vulgaris; Adolescent; Edema; Facial Dermatoses; Humans; Isotretinoin; Male; Tretinoin

Quantitative cultures in 40 patients treated with systemic isotretinoin demonstrated a significant reduction in the anaerobic diphtheroid, Propionibacterium acnes within one month of therapy and a continued suppression during 5 months of treatment. This reduction persisted after discontinuation of isotretinoin therapy despite a return of sebum excretion to pretreatment levels. Surface aerobic bacteria showed a significant reduction in the total number of organisms and significant qualitative changes. Gram negative bacteria were sharply reduced in both the anterior nares and skin while Staphylococcus aureus recovery increased significantly.

Topics: Acne Vulgaris; Humans; Isotretinoin; Propionibacterium acnes; Sebum; Skin; Staphylococcus aureus; Tretinoin

Young men with mild acne vulgaris may rarely experience a very acute exacerbation with ulceration and necrosis of the lesions accompanied by fever, malaise, loss of weight, often by polyarthritis, and occasionally by erythema nodosum. Elevated sedimentation rate and marked leucocytosis are characteristic; microhematuria is often observed. This condition has been called acne fulminans. We report on a young male patient suffering from severe acne fulminans. Systemic 13-cis retinoic acid (Roaccutan, Accutane) and indomethacine (Amuno) treatment rapidly improved the skin and joint lesions. Intracutaneous tests with viral, bacterial, and fungal antigens before and during treatment suggest a temporary cellular immune defect.

Topics: Acne Vulgaris; Adolescent; Drug Therapy, Combination; Humans; Indomethacin; Male; Tretinoin

Full-face or half-face dermabrasions for acne scarring were performed in 123 patients, 88 of whom received pretreatment for at least 2 weeks with 0.05% tretinoin cream. In the group that received tretinoin, healing, as evidenced by reepithelialization, was complete by 7 days; most of these patients completely healed in 5 days. All patients who did not receive tretinoin healed by 11 days, but none healed sooner than 7 days. No milia or postinflammatory hyperpigmentation was experienced by patients treated with tretinoin when the drug was resumed within 1 week after dermabrasion. In the group that received no tretinoin, milia and postinflammatory hyperpigmentation occurred in 28% of patients postoperatively.

Topics: Acne Vulgaris; Administration, Topical; Dermabrasion; Humans; Postoperative Care; Preoperative Care; Tretinoin; Wound Healing

Acne vulgaris is a disorder of sebaceous follicles that usually begins at the time of the sharp increase in androgen production that occurs in adolescence. This disease is most prevalent among teenagers, but it does occur in patients in their twenties and thirties. Three major areas of pathophysiology have been identified in acne: hyperkeratinization and obstruction of sebaceous follicles, resulting from abnormal desquamation of follicular epithelium; an androgen-stimulated increase in the production of sebum; and proliferation of Propionibacterium acnes, which generates inflammation. Disruption of the preclinical precursor lesion known as the microcomedo produces inflammation, which leads to the pustules and papules of clinical disease and may eventually result in scarring. Rational therapy for acne should be directed at the three factors involved in the pathophysiology of the disease. Tretinoin (all-trans-retinoic acid) acts to normalize desquamation of follicular epithelium, promote drainage of comedones, and inhibit formation of new ones. Salicylic acid is also comedolytic, but to a much lesser degree. Benzoyl peroxide and topical or systemic antibiotics work by decreasing the follicular population of P. acnes, thus reducing inflammation. Direct injection of corticosteroids may be used to reduce large inflammatory lesions. Physical removal of comedones is also useful. Severe nodulocystic acne and other cases that fail to respond to these measures may be treated systemically with isotretinoin (13-cis-retinoic acid).

Topics: Acne Vulgaris; Administration, Topical; Anti-Bacterial Agents; Benzoyl Peroxide; Drug Therapy, Combination; Humans; Peroxides; Salicylates; Salicylic Acid; Skin; Tretinoin

Topics: Acne Vulgaris; Adolescent; Arrhythmias, Cardiac; Humans; Male; Quinidine; Tretinoin

64 patients suffering from severe papulopustular acne previously resistant to therapy were treated with 13-cis retinoic acid (isotretinoin) at a dosage of 0.05, 0.1, or 0.2 mg/kg body weight for 20 weeks. After treatment, we performed follow-up examinations for 12 months concerning remission and side effects. After six months, more than half of the patients were free of relapses, even those treated with low doses, although there was a trend in favor of the 0.2 mg/kg body weight dose. According to lesion counts, the therapeutic effect of isotretinoin was even better after discontinuation of the drug. Mucocutaneous side effects disappeared within four to six weeks. In severe papulopustular acne, previously showing inadequate response to therapy, at least 0.2 mg/kg body weight isotretinoin should be given to ensure a good therapeutic result. These findings correspond with those observed in the initial reduction of lesions.

Topics: Acne Vulgaris; Dose-Response Relationship, Drug; Follow-Up Studies; Humans; Isotretinoin; Recurrence; Tretinoin

Topics: Acne Vulgaris; Animals; Etretinate; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Acute Disease; Adult; Arthritis; Humans; Isotretinoin; Male; Tretinoin

The effect of isotretinoin on experimentally induced comedones was studied by means of histoplanimetry and scanning electron microscopy (SEM). To induce comedone formation, insoluble cutting oil was applied to the ventral surface of the ears of rabbits for 2 weeks. After comedones formed, isotretinoin was fed to the rabbits by a feeding tube, daily, for 4 weeks. A low dose (2.0 mg/kg) and a high dose (20.0 mg/kg body weight) were selected for two different groups. Soybean oil served as the vehicle. Histoplanimetrically, the high-dose group showed a significant decrease in size of comedones when compared to the control group and the low-dose group [P less than 0.005], and in the high-dose group, the follicular lumen contained a small number of loose, non-adherent, horny cells. Upon SEM examination, the comedones were seen to have a 'chrysanthemum' appearance before treatment. After treatment, the high- and low-dose groups both showed evidence of the elimination of comedones on three-dimensional analysis.

Topics: Acne Vulgaris; Animals; Isotretinoin; Male; Microscopy, Electron, Scanning; Rabbits; Tretinoin

Topics: Acne Vulgaris; Humans; Isomerism; Isotretinoin; Skin Diseases; Teratogens; Tretinoin

Six patients underwent dermabrasion while on or having recently completed isotretinoin (Accutane) therapy. All patients developed keloids in atypical locations; the keloids eventually responded to topical or intralesional steroid therapy. Retinoids have a modulatory effect on connective tissue metabolism, including suppression of collagenase, which may enhance keloid formation. Dermabrasion should be delayed in those patients taking or recently on isotretinoin therapy.

Topics: Acne Vulgaris; Adult; Dermabrasion; Female; Humans; Isotretinoin; Keloid; Male; Microbial Collagenase; Middle Aged; Tretinoin

The primary change found in cellular material expressed from open comedones of patients who had been treated with isotretinoin was disintegration of desmosomes. Consequently, there was lack of cohesion between cornified cells. A marked decrease in the quantity of sebaceous material and bacteria was also evident within the comedones.

Topics: Acne Vulgaris; Bacteria; Desmosomes; Hair; Humans; Intermediate Filaments; Isotretinoin; Keratins; Sebum; Tretinoin

Seven patients underwent retrospective radiographic examination 10 to 16 months after high dose isotretinoin therapy for severe cystic acne. One patient, who received the highest isotretinoin dose (approximately twice the average dose taken by the remaining patients), had multiple small hyperostoses of the thoracic spine and tarsi navicular. These findings were identical to the skeletal changes known to occur during retinoid administration. Prospective studies are needed to ascertain the risk of developing hyperostoses during isotretinoin therapy for acne at the lower doses currently employed. In this preliminary study, clinically significant hyperostoses were not a late sequela of high dose isotretinoin treatment for acne.

Topics: Acne Vulgaris; Adolescent; Adult; Bone and Bones; Dose-Response Relationship, Drug; Female; Humans; Isotretinoin; Male; Osteochondrodysplasias; Radiography; Spine; Tretinoin

Topics: Acne Vulgaris; Female; Humans; Isotretinoin; Male; Sebaceous Glands; Skin; Tretinoin

Abnormalities in plasma lipids are a recognized side effect of isotretinoin therapy for nodulocystic acne. We studied 60 patients during 20 weeks of isotretinoin therapy, to measure changes in plasma lipids and lipoproteins, to compare plasma lipid responses in men and women, and to determine whether there are alterations in levels of lipoprotein lipase or hepatic triglyceride lipase that could explain the development of isotretinoin-induced hypertriglyceridemia. Mean triglyceride levels rose in men and women, with maximum mean increases of 46.3 mg per deciliter (P less than 0.0001) and 52.3 mg per deciliter (P less than 0.002), respectively. The maximum level was reached by 4 weeks of therapy in men but not until the 12th week in women. Nine of 53 patients (17 per cent) completing 20 weeks of isotretinoin therapy acquired hypertriglyceridemia, with values of 200 to 600 mg per deciliter. Both men and women had significant increases in mean plasma levels of cholesterol and low-density-lipoprotein cholesterol and decreases in mean levels of high-density-lipoprotein cholesterol. There were no significant changes in mean levels of lipoprotein lipase or hepatic triglyceride lipase. Plasma lipid and lipoprotein levels returned to base line by eight weeks after discontinuation of the drug. If sustained over a long period, the change in the ratio of low-density-lipoprotein cholesterol to high-density-lipoprotein cholesterol that we observed, from 2.4 to 3.0 (P less than 0.0001), would predict an increased risk of cardiovascular disease.

Topics: Acne Vulgaris; Adolescent; Adult; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Female; Humans; Isotretinoin; Lipase; Lipids; Lipoprotein Lipase; Lipoproteins; Male; Tretinoin; Triglycerides

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Animals; Exostoses; Female; Humans; Isotretinoin; Lipids; Pregnancy; Tretinoin

A total of 261 adverse ocular reactions occurred in 237 patients who received isotretinoin, a commonly used drug in the treatment of severe cystic acne. Blepharoconjunctivitis, subjective complaints of dry eyes, blurred vision, contact lens intolerance, and photodermatitis are reversible side effects. More serious ocular adverse reactions include papilledema, pseudotumor cerebri, and white or gray subepithelial corneal opacities; all of these are reversible if the drug is discontinued. Reported cases of decreased dark adaptation are under investigation. Isotretinoin is contraindicated in pregnancy because of the many reported congenital abnormalities after maternal use (including microphthalmos, orbital hypertelorism, and optic nerve hypoplasia).

Topics: Acne Vulgaris; Cataract; Conjunctivitis; Cysts; Eye; Eye Diseases; Eyelid Diseases; Humans; Inflammation; Isotretinoin; Photosensitivity Disorders; Skin Diseases; Tretinoin; Vision Disorders

Topics: Acne Vulgaris; Humans; Isotretinoin; Product Labeling; Tretinoin; United States; United States Food and Drug Administration

Topics: Acne Vulgaris; Adrenal Cortex Hormones; Anti-Bacterial Agents; Benzoyl Peroxide; Cryosurgery; Humans; Isotretinoin; Sebaceous Glands; Tretinoin; Ultraviolet Therapy

Topics: Acne Vulgaris; Administration, Topical; Adrenal Cortex Hormones; Benzoyl Peroxide; Cicatrix; Contraceptives, Oral, Hormonal; Humans; Isotretinoin; Minocycline; Propionibacterium acnes; Tetracycline; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Adult; Brain; Female; Heart Defects, Congenital; Humans; Hydrocephalus; Isomerism; Isotretinoin; Pregnancy; Teratogens; Tretinoin

Topics: Acne Vulgaris; Adolescent; Humans; Isotretinoin; Male; Muscle Spasticity; Muscles; Pain; Recurrence; Tretinoin

Topics: Acne Vulgaris; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Humans; Isotretinoin; Rosacea; Tretinoin

Topics: Acne Vulgaris; Adult; Drug Eruptions; Humans; Male; Tretinoin

Topics: Acne Vulgaris; Adrenal Cortex Hormones; Flurandrenolone; Granulation Tissue; Humans; Isotretinoin; Occlusive Dressings; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Androgen Antagonists; Anti-Bacterial Agents; Benzoyl Peroxide; Estrogens; Female; Humans; Isotretinoin; Male; Salicylates; Salicylic Acid; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Female; Follow-Up Studies; Humans; Isotretinoin; Male; Singapore; Tretinoin

The aim of the present study was to evaluate different treatment schedules in some different types of acne using a quantitative counting technique. Systemic treatment with erythromycine 0.5 g daily and topical treatment with clindamycin phosphate solution 1% was found to be optimal from the efficacy/side effect ratio. The combined treatment was tried in heat-provoked and cosmetic acne with favourable results. Doubling of erythromycine dosage could not prevent premenstrual exacerbation of acne. Diazepam 4 mg daily for two weeks followed by an antihistamine in addition to erythromycine 0.5 g daily gave relatively good results in female patients with acne excorié. In acne coexisting with pronounced seborrhoic dermatitis of the face the addition of hydrocortisone cream 1% was of benefit, although Roaccutane may here be the drug of choice. In female postpubertal acne, the effect of cyproteronacetate-etynilestradiol (Diane) was not superior to treatment with erythromycine 0.5 g daily. By treating special subtypes differently, one could be able to improve the results of acne therapy.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Androgen Antagonists; Anti-Inflammatory Agents; Benzoyl Peroxide; Clindamycin; Cyproterone; Cyproterone Acetate; Diazepam; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Erythromycin; Ethinyl Estradiol; Female; Humans; Hydrocortisone; Male; Sulfamethoxazole; Tetracycline; Tretinoin; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Topics: Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide; Cicatrix; Female; Hormones; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Adult; Female; Hair Preparations; Humans; Isotretinoin; Tretinoin

Thirty-two patients with gram-negative folliculitis were treated with 0.47 to 1.0 mg/kg/day of isotretinoin. Serial microbiologic evaluations demonstrated rapid clearing of the face and nasal mucosa of gram-negative rods. The clinical response was rapid, complete, and induced prolonged remissions. Twenty-six of thirty-two patients developed Staphylococcus aureus nasal carriage by the end of the 20-week treatment course. Isotretinoin has decided advantages over previously reported therapies for gram-negative folliculitis.

Topics: Acne Vulgaris; Bacterial Infections; Folliculitis; Gram-Negative Bacteria; Humans; Isomerism; Isotretinoin; Tretinoin

Isotretinoin, a drug used for the treatment of acne, has been shown to have teratogenic effects. We report an additional case of isotretinoin teratogenicity in which the patient had agenesis of the cerebellar vermis, multiple leptomeningeal neuroglial heterotopias, hydrocephalus, and abnormalities of the corticospinal tracts. These findings are related to those reported previously.

Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Acne Vulgaris; Adult; Brain; Female; Humans; Infant, Newborn; Isotretinoin; Teratogens; Tretinoin

Moderate anemia was present in 25% and low serum iron levels in 75% of patients with severe nodulocystic acne. These findings, combined with an elevated serum ferritin level and normal transferrin saturation, indicate that the low serum iron levels and anemia are secondary to the chronic disease state of cutaneous inflammation rather than an iron-deficiency state. Successful therapy of the severe cystic acne with isotretinoin (13-cis-retinoic acid) resulted in return of serum iron and hemoglobin values to normal levels and a decrease in serum ferritin level.

Topics: Acne Vulgaris; Adolescent; Adult; Anemia; Ferritins; Hemoglobins; Humans; Iron; Isotretinoin; Transferrin; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Antigen-Antibody Complex; Erythema Nodosum; Humans; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Erythema; Female; Humans; Isotretinoin; Male; Photosensitivity Disorders; Sunlight; Tretinoin

A group of nine patients with severe nodulocystic acne vulgaris were treated with oral 13-cis-retinoic acid and their acne cleared. During or after retinoid therapy, all patients underwent full-face dermabrasion. Postoperative healing was normal, and no significant complications were seen.

Topics: Acne Vulgaris; Administration, Oral; Adult; Combined Modality Therapy; Dermabrasion; Face; Female; Humans; Isotretinoin; Male; Middle Aged; Time Factors; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Female; Humans; Isotretinoin; Male; Tretinoin

The use of topical tretinoin (Retin-A) for comedonal lesions, benzoyl peroxide for inflamed papules and pustules, and topical or oral antibiotics for more severe or widespread disease gives excellent results for the majority of patients with acne. At present, oral isotretinoin (13-cis-retinoic acid) (Accutane) should be reserved for patients with severe nodulocystic acne whose condition has not responded to an accepted therapeutic regimen. Good patient rapport and follow-up are essential in the management of this common disease.

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Aspartate Aminotransferases; Benzoyl Peroxide; Erythromycin; Female; Humans; Isotretinoin; Tetracycline; Tretinoin; Triglycerides

A comparative clinical study on therapy of nodulocystic acne with 13-cis-retinoic acid was performed in 32 patients. 20 patients were treated with a dose of 1 mg/kg body weight daily, and 12 with a combined therapy: 0.25 mg/kg/day 13-cis-retinoic acid and 0.5 g of tetracycline daily. In both groups the therapy was carried out for 16 weeks. The effect of the combined therapy within 4 months was favourable in 75% of the cases versus 100% in the group treated with larger doses of 13-cis-retinoic acid. Thus, the time needed for clearing was longer in some patients (up to 6 months). However, the incidence of side effects was considerably lower in the group of combined therapy. In acne fulminans 13-cis-retinoic acid alone is not effective and should be combined with corticosteroids.

Topics: Acne Vulgaris; Adolescent; Adult; Drug Therapy, Combination; Female; Humans; Isotretinoin; Male; Prednisone; Tetracycline; Time Factors; Tretinoin

A florid case of osteoma cutis was observed following isotretinoin treatment of severe cystic acne in which a few scattered osteomata of the skin were observed prior to the treatment with isotretinoin.

Topics: Acne Vulgaris; Adult; Facial Neoplasms; Female; Humans; Isomerism; Isotretinoin; Osteoma; Skin Neoplasms; Time Factors; Tretinoin

Topics: Acne Vulgaris; Anti-Bacterial Agents; Cyproterone; Cyproterone Acetate; Estrogens; Female; Humans; Male; Progesterone; Tretinoin

Eight male subjects aged 18-24 years were treated with 0.5 mg of isotretinoin day-1 kg-1. After 4 weeks levels of cholesterol (P less than 0.05) and triglyceride (P less than 0.05) were increased and levels of high-density lipoprotein (HDL)-cholesterol were decreased (P less than 0.05). Concentrations of aspartate aminotransferase (P less than 0.01) and gamma-glutamyltranspeptidase (P less than 0.01) were higher after treatment; increased alkaline phosphatase and a reduction in bilirubin levels did not reach statistical significance. Values for thyroxine were reduced after isotretinoin and free thyroxine index was lower (P less than 0.01). Measurements of salivary clearance of antipyrine and levels of alpha 1-acid glycoprotein were lower after treatment but these differences did not reach statistical significance. The findings suggest that there is a small decrease in hepatic microsomal-enzyme activity after isotretinoin and that the unwanted effects on lipids, liver and thyroid function are unlikely to be due to hepatic microsomal-enzyme induction.

Topics: Acne Vulgaris; Adolescent; Adult; Antipyrine; Humans; Isotretinoin; Lipids; Male; Metabolic Clearance Rate; Orosomucoid; Teratogens; Tretinoin

Twenty male volunteers with severe acne conglobata were treated orally over a period of 12 weeks with 1 mg isotretinoin (13-cis-retinoic acid) per kilogram body weight. Before and after therapy, as well as 12 weeks after the end of therapy, the semen was examined spermatologically and the spermatozoa DNS determined by impulse cytophotometry. The sperm density remained unchanged in the otherwise healthy patients, whereas patients with previous gonadal defects (unilateral cryptorchism, hypogonadism, varicocele) the sperm count rose significantly (P less than 0.05) at the end of therapy; 3 months later a reverse trend in the sperm density was noted. The percentage of morphologically normal spermatozoa was slightly reduced at the end of therapy; 12 weeks after completion of therapy it was significantly reduced (P less than 0.05). This could, however, be due to the short elimination half-life of 13-cis retinoic acid and have nothing to do with the drug. On impulse cytophotometry the spermatozoa DNS showed no significant changes. According to the results of the cytophotometric examination, contraceptive measures for men during treatment with 13-cis-retinoic-acid need not be made obligatory.

Topics: Acne Vulgaris; Adult; DNA; Flow Cytometry; Humans; Isotretinoin; Male; Semen; Sperm Count; Spermatogenesis; Spermatozoa; Tretinoin

Topics: Acne Vulgaris; Adolescent; Betamethasone; Clobetasol; Granulation Tissue; Humans; Inflammation; Isotretinoin; Male; Tretinoin

The Sebumeter method used in this study for quantitative analysis of skin surface lipids differs from previous techniques in simple handling and quick practicability and is therefore helpful in the clinical routine. Sebumetrical measurements carried out on healthy persons revealed symmetrical distribution of skin surface lipids. The highest levels were found on the forehead; young people generally showed higher values than older persons. During therapy with 13-cis retinoic acid on acne patients for 6 months (0.5 mg/kg daily), we found reduction of the random level in the first month, particularly in the forehead region. During therapy with minocycline on 3 acne patients for 3 months (2 X 50 mg daily), there was no variation of the random level observed. UVA irradiation on the face for 10 minutes daily (0.55 J/cm2/min) over a period of 3 weeks resulted in continuous reduction of the random level in most of the tested persons; a small part of them reacted by fluctuating values.

Topics: Acne Vulgaris; Adolescent; Adult; Age Factors; Aged; Child; Humans; Lipid Metabolism; Lipids; Middle Aged; Minocycline; Skin; Tetracyclines; Tretinoin; Ultraviolet Therapy

Topics: Acne Vulgaris; Anti-Inflammatory Agents; Bromine; Dermatitis Herpetiformis; Diagnosis, Differential; Folliculitis; Halogens; Humans; Iodine; Potassium Iodide; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Adolescent; Adult; Female; Humans; Isotretinoin; Pregnancy; Risk; Tretinoin

Retinoic acid, an analogue of vitamin A, is known to be teratogenic in laboratory animals and has recently been implicated in a few clinical case reports. To study the human teratogenicity of this agent, we investigated 154 human pregnancies with fetal exposure to isotretinoin, a retinoid prescribed for severe recalcitrant cystic acne. The outcomes were 95 elective abortions, 26 infants without major malformations, 12 spontaneous abortions, and 21 malformed infants. A subset of 36 of the 154 pregnancies was observed prospectively. The outcomes in this cohort were 8 spontaneous abortions, 23 normal infants, and 5 malformed infants. Exposure to isotretinoin was associated with an unusually high relative risk for a group of selected major malformations (relative risk = 25.6; 95 per cent confidence interval, 11.4 to 57.5). Among the 21 malformed infants we found a characteristic pattern of malformation involving craniofacial, cardiac, thymic, and central nervous system structures. The malformations included microtia/anotia (15 infants), micrognathia (6), cleft palate (3), conotruncal heart defects and aortic-arch abnormalities (8), thymic defects (7), retinal or optic-nerve abnormalities (4), and central nervous system malformations (18). The pattern of malformation closely resembled that produced in animal studies of retinoid teratogenesis. It is possible that a major mechanism of isotretinoin teratogenesis is a deleterious effect on cephalic neural-crest cell activity that results in the observed craniofacial, cardiac, and thymic malformations.

Topics: Abnormalities, Drug-Induced; Abortion, Spontaneous; Acne Vulgaris; Adolescent; Adult; Female; Fetal Death; Heart Defects, Congenital; Humans; Infant, Newborn; Isotretinoin; Male; Pregnancy; Pregnancy Trimester, First; Prospective Studies; Retrospective Studies; Risk; Tretinoin

Topics: Acne Vulgaris; Adult; Contraceptives, Oral; Contraceptives, Oral, Combined; Drug Interactions; Female; Humans; Isotretinoin; Tretinoin

Twelve patients with acne vulgaris treated with isotretinoin for 4 months showed increased levels of immunoglobulins and helper T cells at 8 weeks and increased levels of B cells at 16 weeks.

Topics: Acne Vulgaris; alpha-Macroglobulins; Complement C3; Female; Humans; Immunoglobulins; Inflammation; Isotretinoin; Lymphocytes; Male; Tretinoin

Treatment with 13-cis-retinoic acid during 12 weeks of a patient with multiple trichoepitheliomas and acne cystica et comedonica did not affect the number of trichoepitheliomas. The cystic lesions, most of them trichoepitheliomas with only a few non-inflammatory cystic acne lesions, were not affected by this treatment.

Topics: Acne Vulgaris; Adult; Face; Humans; Isotretinoin; Male; Neck; Skin Neoplasms; Tretinoin

Topics: Acne Vulgaris; Adolescent; Granuloma; Humans; Isotretinoin; Male; Time Factors; Tretinoin

Vitamin A is essential for growth and development, reproduction and vision in humans. Chemical modification of vitamin A has yielded compounds showing therapeutic promise in skin and neoplastic diseases. The medicinal use of retinoids (vitamin A and its derivatives) is limited by the toxicity associated with this group of compounds. One retinoid, 13-cis-retinoic acid, has proved to be quite effective in the treatment of severe recalcitrant cystic acne under conditions in which toxicity is manageable.

Topics: Acne Vulgaris; Adolescent; Humans; Hypervitaminosis A; Isotretinoin; Male; Retinoids; Tretinoin; Vitamin A Deficiency

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Humans; Tretinoin

Twenty-eight patients with severe acne and one with hidradenitis suppurativa and acne were treated for 12 to 16 weeks with a new synthetic retinoid, isotretinoin (Roaccutane). The average dose was 0.56 mg/kg/day. Patients were seen weekly for four weeks and then fortnightly for the remaining treatment period, being evaluated both qualitatively and quantitatively. Twenty-five patients had an excellent response. Two to five months after the end of treatment no patient had relapsed. No patient withdrew because of side effects, but all suffered dry lips. This study confirms the potential of isotretinoin in the treatment of severe acne.

Topics: Acne Vulgaris; Acute Disease; Adult; Capsules; Cheilitis; Drug Evaluation; Female; Follow-Up Studies; Humans; Isotretinoin; Male; Time Factors; Tretinoin

Isotretinoin is remarkably effective in the treatment of severe cystic acne, however, many complications have been observed during treatment and new toxic effects have been reported. Hypertriglyceridemia associated with decreases in high density lipoprotein (HDL) cholesterol has occurred in 25 percent of patients and requires monitoring during treatment. Painful erosions with granulation tissue recently have been reported in patients with severe acne. Other complications have included corneal opacities, pseudotumor cerebri, hypercalcemia, photosensitivity reactions, abnormal liver function tests, and skeletal hyperostosis. Isotretinoin is teratogenic and should be avoided during pregnancy. With the increasing acceptance and use of isotretinoin for cystic acne, as well as related disorders (inflammatory papulopustular acne with scarring, gram-negative folliculitis, and acne rosacea), a reevaluation of isotretinoin aimed at reducing complications is in order. Patient selection criteria and guidelines directed at reducing these complications are presented.

Topics: Acne Vulgaris; Female; Humans; Isotretinoin; Mucous Membrane; Pregnancy; Skin Diseases; Teratogens; Tretinoin; Triglycerides

Topics: Acne Vulgaris; Adolescent; Arthritis; Diseases in Twins; Female; Humans; Isotretinoin; Male; Pregnancy; Tretinoin; Twins, Monozygotic

46 patients suffering from severe forms of acne conglobata were treated with 13-cis-retinoic acid. The initial dosages of 40, 60 or 80 mg of 13-cis-retinoic acid per day were adapted according to the success of therapy or to severe side effects. Pustules and papules responded promptly followed by the reduction of nodes and cysts. The lesions of the face responded quicker than those of chest and back. After 6 months of therapy, the overall reduction of all acne lesions was 94.4% for the face and 85.8% for chest and back. Thus, the out-standing efficacy of 13-cis-retinoic acid in severe forms of acne conglobata has been documented once more.

Topics: Acne Vulgaris; Female; Humans; Isotretinoin; Male; Tretinoin

A pityriasis rosea-like eruption developed in two acne patients receiving isotretinoin and gradually resolved once the dosage was reduced. Histologically the lesions, which were characterized by psoriasiform hyperplasia, bore no resemblance to pityriasis rosea. We believe the eruptions were a side effect of isotretinoin therapy.

Topics: Acne Vulgaris; Adolescent; Adult; Diagnosis, Differential; Drug Eruptions; Female; Humans; Isotretinoin; Male; Pityriasis; Tretinoin

Topics: Acne Vulgaris; Adult; Creatine Kinase; Female; Humans; Isotretinoin; Physical Exertion; Tretinoin; Weight Lifting

Topics: Acne Vulgaris; Follow-Up Studies; Humans; Isotretinoin; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Cost-Benefit Analysis; Female; Humans; Infant, Newborn; Isotretinoin; Pregnancy; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Female; Humans; Isotretinoin; Male; Tretinoin

A patient developed transient, acute myopia while on isotretinoin (Accutane) therapy for acne. This idiosynactic adverse reaction has not been previously described. There was a clear relationship between restarting the Accutane and recurrence of the transient myopia.

Topics: Acne Vulgaris; Acute Disease; Adult; Female; Humans; Isotretinoin; Myopia; Tretinoin

Topics: Acne Vulgaris; Adolescent; Chronic Disease; Follow-Up Studies; Granuloma; Humans; Isotretinoin; Male; Skin Diseases; Tretinoin

Topics: Acne Vulgaris; Granulation Tissue; Humans; Isotretinoin; Tretinoin; Wound Healing

Treatment with isotretinoin (retinoic acid), which is frequently used in the control of acne, is associated with transient arthralgias in up to 16% of patients. We encountered two cases of acute, aseptic arthritis of the knee in male patients receiving isotretinoin, during the third week and third month of therapy. Synovial fluid obtained from one of the patients was noninflammatory. The drug concentration in the synovial fluid was 131 ng/mL--a level that was compatible with diffusion from the blood (simultaneous serum concentration, 229 ng/mL). Arthritis resolved in both patients without sequelae, despite continuation of drug treatment in one of them. This observation indicates that arthritis with joint effusion may complicate isotretinoin use; it also suggests that alternative measures should be considered before administering the drug to patients with rheumatologic disorders.

Topics: Acne Vulgaris; Acute Disease; Adult; Arthritis; Humans; Isotretinoin; Male; Tretinoin

The clinical and laboratory toxic findings of ninety-four patients receiving systemic isotretinoin therapy for cystic acne are listed. A comparison of the toxicity for two different dosage schedules is made. Coexistent diseases such as ulcerative colitis, manic depression psychoses, Gilbert's disease and cluster headaches are unaffected by this systemic medication.

Topics: Acne Vulgaris; Cholesterol; Female; Humans; Isotretinoin; Liver Function Tests; Male; Random Allocation; Time Factors; Tretinoin; Triglycerides

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Face; Female; Fetus; Humans; Infant, Newborn; Isotretinoin; Male; Maternal-Fetal Exchange; Pregnancy; Pregnancy Complications; Skull; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Adolescent; Ear, External; Female; Fetus; Humans; Hydrocephalus; Infant, Newborn; Isotretinoin; Maternal-Fetal Exchange; Pregnancy; Pregnancy Complications; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Adolescent; Adult; Central Nervous System; Female; Humans; Infant, Newborn; Isotretinoin; Male; Pregnancy; Tretinoin; Triglycerides

Bilateral 2.5 and 3.0 mm nasal bone osteophytes developed five weeks following the initiation of oral isotretinoin therapy (50 mg daily) for severe cystic acne vulgaris in a healthy 30-year-old white woman who had undergone uneventful rhinoplasty 12 years earlier. Histologically mature bone fragments were removed at surgery. Vitamin A and its analogs have been reported to cause hyperostosis of the vertebrae and long bones, but no known reports link them to nasal bone changes. Clinically significant nasal bone osteophytosis may be another adverse reaction to oral isotretinoin therapy.

Topics: Acne Vulgaris; Adult; Bone Diseases; Female; Humans; Isotretinoin; Nasal Bone; Rhinoplasty; Risk; Tretinoin

The intradermal injection of 140 micrograms of Propionibacterium acnes (CN 6134) into the ears of female Sprague-Dawley rats produced a chronic inflammation with formation of acneiform lesions. Inflammation was characterized by more than a doubling of ear thickness at 24 h and a peak of 3-4 times control levels at day 21. At 42 days post injection ears were still 3 times normal thickness. Histologically there was early polymorph accumulation giving way to macrophages and lymphocytes by day 7. Pilosebaceous follicles overlying the inflamed area lost their sebaceous glands and became hyperplastic cords of cells that grew down and encapsulated inflammatory loci. By day 9 many of these follicles had become secondary comedones. Three isolates of P. acnes from inflammatory acne lesions and 4 of 5 isolates from non-acne patients produced results similar to that of the strain CN 6134. In these cases the number of histologically evident secondary comedones was correlated with ear thickness. In contrast, samples of Streptococcus lactis, Escherichia coli B, and Staphylococcus epidermidis failed to produce this combination of chronic inflammation and high lesion count. Benzoyl peroxide, tetracycline, erythromycin, phenidone, naproxen, and cis and trans retinoic acid were inactive as inhibitors of P. acnes CN 6134-induced ear thickening. The corticosteroid fluocinolone acetonide produced dramatic suppression of inflammation, but upon cessation of treatment the ears returned to inflamed levels. The specificity for P. acnes, the formation of acneiform lesions, and the recalcitrance of the inflammation suggest our model is indeed relevant to acne.

Topics: Acne Vulgaris; Animals; Benzoyl Peroxide; Disease Models, Animal; Erythromycin; Female; Fluocinolone Acetonide; Inflammation; Injections, Intradermal; Naproxen; Propionibacterium acnes; Pyrazoles; Rats; Rats, Inbred Strains; Tetracycline; Tretinoin

Pseudotumor cerebri developed in a 14-year-old girl with nodulocystic acne, who was taking excessive amounts of a synthetic vitamin A derivative. Although hypervitaminosis A has reportedly caused pseudotumor, Accutane has not previously been implicated.

Topics: Acne Vulgaris; Adolescent; Female; Humans; Isotretinoin; Pseudotumor Cerebri; Tretinoin; Vitamin A

Topics: Abnormalities, Drug-Induced; Abortion, Induced; Acne Vulgaris; Germany, West; Humans; Isotretinoin; Risk; Tretinoin

Topics: Acne Vulgaris; Humans; Isotretinoin; Retinoids; Skin Diseases; Tretinoin

Multiple polypoid projections of granulation tissue developed in two patients receiving isotretinoin for acne. Histological study of the lesions revealed increased amounts of non-sulphated acid mucopolysaccharides in the ground substance of the granulation tissue stroma. Complete resolution occurred following curettage with or without chemical cautery. The role of isotretinoin in the development of these lesions is discussed.

Topics: Acne Vulgaris; Adult; Granulation Tissue; Humans; Isomerism; Isotretinoin; Male; Skin; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Benzoyl Peroxide; Cyproterone; Cyproterone Acetate; Double-Blind Method; Erythromycin; Female; Humans; Isotretinoin; Male; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Animals; Drug Eruptions; Humans; Rabbits; Skin; Tretinoin

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Combined Modality Therapy; Dermatologic Agents; Female; Gonadal Steroid Hormones; Humans; Male; Prognosis; Sebum; Tretinoin

Forty patients suffering of different forms of acne (papulo-pustular, nodulo-cystic, conglobata, rosacea), all in severe conditions and non-responding to other treatments, have been administered 13-cis-retinoic acid p.o. The treatment resulted in a complete and ultimate healing in 31 pts (77.5%) and a marked amelioration in the remaining 9 cases. The initial drug dosage was 40 mg/die (an average of 0.66 mg/kg/die) but it was reduced along the treatment to 2.5 mg/die, a still effective dose. The average treatment duration was 24 weeks (range: 12 to 40). The tolerance was generally excellent, but some adverse effect have been recorded, mainly localized in the skin and mucosa. Increases of total serum cholesterol (66% of the cases) and of triglyceride (72%) level have been observed. This effect was reversible at the end of the treatment. As a conclusion we can confirm that the 13-cis-retinoic acid is the most effective drug for the pharmacotherapy of severe acne.

Topics: Acne Vulgaris; Adult; Alkaline Phosphatase; Alopecia; Cholesterol; Drug Tolerance; Epistaxis; Female; Humans; Isotretinoin; Male; Pruritus; Rosacea; Transaminases; Tretinoin; Triglycerides

Topics: Acne Vulgaris; Humans; Isotretinoin; Lipids; Tretinoin

Topics: Acne Vulgaris; Humans; Isotretinoin; Lipids; Risk; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Female; Humans; Infant, Newborn; Isotretinoin; Maternal-Fetal Exchange; Pregnancy; Tretinoin

Topics: Acne Vulgaris; Exostoses; Humans; Isotretinoin; Tretinoin; United States; United States Food and Drug Administration

Topics: Acne Vulgaris; Acute Disease; Administration, Oral; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Dehydroepiandrosterone; Dexamethasone; Exostoses; Female; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Humans; Isotretinoin; Psoriasis; Tretinoin

Five subjects with serious cystic acne, two of which were also affected by hydrosadenitis, were examined during a treatment with 13-cis-retinoic acid. The drug was given at decreasing doses: 0.9 mg/kg body weight for a period of six weeks, followed by a second six weeks period at 0.6 mg/kg and lastly by another 9 months period at 0.3 mg/kg. The patients had a good response to the treatment with a rapid reduction of the number and of the severity of the acneic lesions, with the only exception of one subject who had a relapse at the 18th week. This study, limited to a small number of patients, suggest that 13-cis-retinoic acid may be used in severe cystic acne with a higher dosage in the presence of complicating hydrosadenitis.

Topics: Acne Vulgaris; Adolescent; Adult; Humans; Isotretinoin; Time Factors; Tretinoin

Topics: Acne Vulgaris; Humans; Isotretinoin; Tears; Tretinoin

Topics: Acne Vulgaris; Humans; Isotretinoin; Lipids; Tretinoin

Topics: Acne Vulgaris; Female; Humans; Isotretinoin; Male; Pregnancy; Tretinoin

Topics: Acne Vulgaris; Humans; Male; Spermatogenesis; Tretinoin

Twenty-one patients with severe acne (acne papulopustulosa, acne conglobata, acne cystica), six patients with severe rosacea (rosacea paulopustulosa, rosacea conglobata, rhinophyma), and three patients with tuberous sclerosis were treated with 13-cis-retinoic acid for 6-48 weeks. Most patients had been previously treated with dermabrasion, antibiotics or metronidazole. Dependent on the severeness of the pathological symptoms 13-cis-retinoic acid was administered at a dose of 0.2 to 0.5 mg/kg body weight and was then reduced every 4 weeks. We confirm the sebostatic and antiinflammatory effect of the 13-cis-retinoic acid and long-lasting remissions. Side effects had not been serious.

Topics: Acne Vulgaris; Adenoma; Administration, Oral; Adolescent; Adult; Aged; Female; Humans; Isomerism; Isotretinoin; Male; Middle Aged; Rosacea; Sebaceous Gland Neoplasms; Tretinoin

13-cis-Retinoic acid (Accutane) is an effective new agent for the treatment of severe cystic acne. The most encouraging feature associated with use of this drug is the persistence of remissions even after administration has been discontinued. The cutaneous side effects are mild to moderate and are usually well tolerated. Careful monitoring of the serum lipids is necessary. In 4 of our 10 patients, the levels of triglycerides became elevated. Of these four patients, three had lowering of the high-density lipoprotein fraction. In three of our most severely affected patients, nonhealing erosions with heaped-up granulation tissue developed at the sites of large acne cysts, which healed promptly after therapy was completed. For the present, we emphasize that use of Accutane should be reserved for severe acne that is unresponsive to conventional treatment; in such cases, careful clinical and laboratory monitoring is imperative.

Topics: Acne Vulgaris; Adolescent; Adult; Animals; Humans; Isotretinoin; Male; Rabbits; Rats; Skin Diseases; Tretinoin; Triglycerides

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Drug Eruptions; Humans; Isomerism; Isotretinoin; Male; Skin; Tretinoin

Topics: Acne Vulgaris; Dose-Response Relationship, Drug; Humans; Sebum; Tretinoin

Topics: Acne Vulgaris; Female; Humans; Isomerism; Isotretinoin; Male; Pregnancy; Tretinoin

Topics: Acne Vulgaris; Adult; Cysts; Female; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Adult; Humans; Hypercalcemia; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Humans; Isotretinoin; Substance-Related Disorders; Tretinoin

The authors show that the use of Isotretinoin (Ro 4-3740) in cystic acne brings a reduction of chemotactic activity of the neutrophil granulocytes, like another retinoid, Etretinate, in pustular and vulgar psoriasis. This effect of retinoids, with a direct action on the polymorphonuclear leukocytes plays an important role in the recovery of the disease.

Topics: Acne Vulgaris; Adolescent; Adult; Chemotaxis, Leukocyte; Humans; Isotretinoin; Male; Neutrophils; Tretinoin

In our clinical trials of isotretinoin therapy for cystic acne and etretinate treatment of psoriasis, eight patients had growth of excessive granulation tissue. The granulation tissue was found in resolving acne lesions in one patient taking isotretinoin. Among the psoriatic patients taking etretinate, the granulation tissue usually was seen adjacent to nail plates. In two patients, the side effect caused them to stop retinoid therapy. The tissue response did not appear to be related to the daily or cumulative retinoid dose.

Topics: Acne Vulgaris; Adolescent; Adult; Aged; Granulation Tissue; Granuloma; Humans; Isotretinoin; Male; Middle Aged; Psoriasis; Skin Diseases; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Cicatrix; Dermatologic Agents; Erythromycin; Estrogens; Humans; Sebum; Tetracycline; Tretinoin

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Drug Administration Schedule; Drug Eruptions; Female; Humans; Isotretinoin; Mucous Membrane; Pregnancy; Tretinoin

56 patients with nodulocystic acne, hidrosadenitis (2 cases) and steatocystoma multiplex (2 cases) were treated with oral isotretinoin. 52 patients cleared completely or were much improved without local treatment; 2 failures involved patients with steatocystoma, while 2 patients with ano-inguinal lesions were only improved. 19 patients received a dose of 0.5 mg/kg/day for six months; in 37 patients the dose was adapted to the initial response but did not exceed 1 mg/kg/day. Reversible elevated triglyceride concentration was observed in 5% of the patients. 18 patients were followed up and 4 (22%) presented moderate relapses.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Dose-Response Relationship, Drug; Epidermal Cyst; Female; Humans; Inflammation; Isotretinoin; Male; Sweat Gland Diseases; Tretinoin

The study presents clinical data and results of skin sebum (SER) determinations during 13-cis-retinoic acid treatment in 15 patients suffering from severe conglobate and cystic acne. The striking clinical improvement was mostly accompanied by decreased SER as well as changes in the composition of the skin surface lipids. While the sebaceous gland lipids were generally reduced, the epidermal lipids showed irregular tendencies. Despite of good therapy effects, 3 patients showed increased SER. This indicates that other mechanisms than those of sebum suppression may be responsible for the treatment success. Sebum suppression and modulation are important and valuable aspects for documentation as well as for elucidation of the working mechanism of 13-cis-retinoic acid.

Topics: Acne Vulgaris; Adult; Female; Humans; Isotretinoin; Lipids; Male; Sebum; Tretinoin

The naturally occurring retinoids (vitamin A alcohol = retinol and all-trans-retinoic acid) have been largely replaced by synthetic retinoids in recent years as systemic drugs for use in dermatology. At the present time, two synthetic retinoids are commercially available: etretinate (Tigason) and isotretinoin (Accutane). These compounds-which have a more favourable therapeutic index than the naturally occurring retinoids-ushered in a new era of dermatological therapy by their potent antikeratinizing, antiseborrhoeic (only isotretinoin) and antineoplastic action. The broadest indications for the use of these retinoids are psoriasis (etretinate) and cystic acne (isotretinoin), whereas the most dramatic effects are encountered in a number of severe ichthyosiform disorders. Another important, although at present not clearly defined role of the retinoids is in the prophylaxis of skin tumours.

Topics: Acne Vulgaris; Etretinate; Humans; Ichthyosis; Isotretinoin; Psoriasis; Retinoids; Skin Diseases; Skin Neoplasms; Tretinoin

Topics: Acne Vulgaris; Humans; Isotretinoin; Keratins; Psoriasis; Skin Diseases; Skin Neoplasms; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Female; Humans; Male; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Inflammatory Agents; Female; Folliculitis; Humans; Isotretinoin; Male; Rosacea; Skin Diseases; Tretinoin

Clinical and experimental investigations to characterize therapeutic effects of topically applied benzoyl peroxide (5 and 10% in alcohol-free gel formulation) were performed with: quantitative determination of bacteria in the follicular filaments with the cyanoacrylate technique (P. acnes and micrococcaceae); agar diffusion method for bacteriostatic effects; semi-quantitative determination of skin surface lipids (ground glass method); lipid solvent and thin-layer chromatography (free fatty acids vs. triglycerides); scanning electron microscopy of the skin surface; exfoliative cytology with corneocyte counts in a Fuchs-Rosenthal chamber (corneocytes/cm2 skin surface); determination of corneocyte surface are in micrometer2; and a clinical trial concerning efficacy and tolerance of the gel formulation. Topically applied benzoyl peroxide acts antibacterially and keratolytically, has anti-lipolytic activity, reduces bacteria in the follicular infundibula, but does not inhibit sebum production as measured by skin surface lipids. Benzoyl peroxide stimulates the epidermopoiesis with reduction of corneocytes/cm2 from 87,400 +/- 29,000 to 36,000 +/- 19,000 (day 15 of treatment) with diminution in size of corneocytes from 1,018 micrometers2 +/- 74 to 865 micrometers2 +/- 65 vs. 832 micrometers2 +/- 85 (5% vs. 10% benzoyl peroxide). Alcohol-free gels of benzoyl peroxide are better tolerated by acne patients than those containing alcohol, in particular when combined with topical tretinoin (vitamin A acid) treatment.

Topics: Acne Vulgaris; Adolescent; Adult; Bacteria; Benzoyl Peroxide; Cyanoacrylates; Drug Tolerance; Humans; Lipids; Male; Peroxides; Skin; Tretinoin; Yeasts

Topics: Acne Vulgaris; Humans; Neoplasms; Psoriasis; Skin Diseases; Tretinoin; Vitamin A

Isotretinoin was administered orally for 16 weeks, in a dosage of 1 mg/kg/day, to seven men with severe acne. A 36.2% reduction of nodulocystic lesions was observed at the conclusion of treatment and a 47.2% reduction was noted at the end of a 16-week follow-up period. However, there was an 88.4% decrease in sebum production and a marked reduction histologically in sebaceous gland size after 16 weeks of treatment, with a partial recovery of glandular activity at 32 weeks. The failure to observe a more striking overall response clinically resulted primarily from two of the seven patients showing worsening or no improvement of their disease, despite profound sebaceous gland inhibition. These findings suggest that the marked sebostatic effect of isotretinoin may not be the sole explanation for its mechanism of action in reducing the severity of acne.

Topics: Acne Vulgaris; Adult; Epidermis; Humans; Inflammation; Isotretinoin; Male; Sebaceous Glands; Sebum; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Cyproterone; Cyproterone Acetate; Drug Evaluation; Female; Humans; Male; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Humans; Isotretinoin; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Clindamycin; Diagnosis, Differential; Erythromycin; Female; Humans; Isomerism; Isotretinoin; Male; Tetracyclines; Tretinoin

Retinoids possess regulatory influences on growth and differentiation of epithelial tissues. They induce a population of keratinozytes with normal pattern of differentiation, they have antiproliferative properties, and they show antineoplastic effects by inhibition of malignant transformation of cells in vitro. Also the dermis undergoes distinct alterations under oral administration of retinoids. By stimulating T-lymphocytes and by inhibition of neutrophil migration retinoids seem to develop immunmodulating and antiinflammatory effects. The aromatic retinoid Etretinate is therapeutically used in severe forms of psoriasis and in various genodermatoses with disorders of keratinization as for example ichthyosis, dyskeratosis follicularis Darier, and pityriasis rubra pilaris.

Topics: Acne Vulgaris; Administration, Oral; Etretinate; Humans; Isomerism; Isotretinoin; Psoriasis; Rosacea; Skin Diseases; Tretinoin

Topics: Acne Vulgaris; Adolescent; Etretinate; Humans; Male; Tretinoin

Topics: Acne Vulgaris; Blepharitis; Conjunctivitis; Eyelid Diseases; Humans; Isotretinoin; Tretinoin

Serum lipid concentrations were measured in eighteen patients with severe acne before, during and after treatment with 0.8 mg/kg 13-cis-retinoic acid for 3 months. Cholesterol and triglyceride concentrations increased and HDL-cholesterol concentrations fell significantly during therapy. There were significant abnormalities of liver function and small decreases in indices of thyroid function. These changes had reverted to normal by 1 month after treatment. The data suggest that use of the drug in acne is likely to be limited by its toxicity.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Cholesterol; Cholesterol, HDL; Female; Humans; Isotretinoin; Lipids; Lipoproteins, HDL; Liver; Male; Thyroid Gland; Tretinoin; Triglycerides

Topics: Acne Vulgaris; Humans; Isotretinoin; Tretinoin

Alterations in lipid metabolism have been reported under treatment of various skin disorders with oral retinoids. In 36 patients, mostly psoriatics, under administration of aromatic retinoid (Ro 10-9359) in various dosages serum triglycerides and cholesterol were estimated; in 25 out of 36 patients lipid analysis of the lipoproteins and apoproteins A (HDL) and B (LDL) has been performed. To reveal possible similarities of lipid changes under the two main retinoids we determined the same parameter in 10 patients with conglobate acne treated orally with 13-cis-retinoic acid (isotretinoin/Ro 4-3780 1mg/kg b.w.). Under both drugs serum triglyceride and cholesterol levels were significantly increased. In contrast to the results under the aromatic derivate the HDL- and LDL-cholesterol fractions were changed under isotretinoin. The apoprotein A (HDL) was found significantly increased under aromatic retinoid. Elevated serum lipids mostly occurred in patients having risk factors such as preexisting lipid abnormalities, obesity, diabetes mellitus, heavy smoking, alcohol abuse and hyperlipemia-inducing drugs. Patients to be treated with these drugs should be carefully followed up in order to minimize the risk for atheromatosis.

Topics: Acne Vulgaris; Adult; Etretinate; Female; Humans; Lipids; Male; Middle Aged; Psoriasis; Tretinoin

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Contraceptives, Oral, Hormonal; Dermatologic Agents; Female; Humans; Male; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Aged; Female; Hair; Humans; Isomerism; Isotretinoin; Male; Middle Aged; Rosacea; Tretinoin

Topics: Acne Vulgaris; Adult; Cysts; Female; Humans; Isotretinoin; Male; Skin; Skin Diseases; Tretinoin

Ten patients treated with 13-cis-retinoic acid demonstrated a 70% reduction in sebum excretion on the forehead and cheek. An average reduction of 66% occurred in the 1st month, slowly increased to 70% by the 3rd month, and then remained constant for the final 2 months of therapy. Concomitant with this sebum excretion reduction was a fall in the number of Propionibacterium acnes recovered from both sites. Pretreatment values of 10(4) P. acnes per square centimeter (cm2) fell to 10(3) per cm2 after 1 month and 10(2) after 9 months of therapy. P. acnes was not recovered from six of the ten subjects in the following 3 months and only at levels of 10(2) per cm2 in three subjects. One subject's P. acnes level was reduced to only 10(4) per cm2. Following discontinuation of therapy, sebum levels and P. acnes counts showed a trend to recover to pretreatment levels within 2 months.

Topics: Acne Vulgaris; Adult; Humans; Isotretinoin; Male; Propionibacterium acnes; Sebum; Skin; Tretinoin

15 patients with severe nodulo-cystic acne were treated with 13-cis retinoic acid (Ro 4-3780) for 6 to 12 months. The initial dose was 40 mg/day in all the cases. In 14 out of 15 cases this dose was progressively reduced depending on improvement of the acne lesions and on the occurrence of side effects. In one case the initial dose was later increased to 60 mg/day because of lack of response to the treatment. A 75 p. 100 improvement in the severity of the acne lesions was achieved within 4 to 5 months. Complete disappearance of the lesions was achieved in most of the patients after between 6 and 12 months of treatment. The most frequent clinical side effects were dryness of the lips, cheilitis with rhagades and facial dermatitis. Abnormal increased values of hepatic enzymes and triglycerides were found in some patients.

Topics: Acne Vulgaris; Adult; Humans; Male; Time Factors; Tretinoin

A high-performance liquid chromatography (HPLC) method for the quantitation of 13-cis-retinoic acid (13-cis-RA) and its major metabolite, 4-oxo-13-cis-RA, in human blood has been developed. The method includes extraction of 1 ml of blood with diethyl ether at pH 6 and the analysis of the extract by reversed-phase HPLC with solvent programming and detection at 365 nm. The quantitation ranges for 13-cis-RA and 4-oxo-13-cis-RA are 10--2000 and 50--2000 ng/ml of blood, respectively. The method also provides estimates of the concentrations of all-trans-RA and 4-oxo-all-trans-RA. The mean intra- and inter-assay variabilities for all four compounds were 6% or less. The method separates 13-cis-RA and 4-oxo-13-cis-RA from 9-cis-RA, all-trans-RA, 4-oxo-all-trans-RA, and some other possible metabolites, such as hydroxy and epoxy retinoic acids. The method has been successfully applied to the analyses of over 1200 blood samples from four 13-cis-RA clinical studies.

Topics: Acne Vulgaris; Blood Preservation; Chromatography, High Pressure Liquid; Humans; Isotretinoin; Reference Standards; Tretinoin

Topics: Acne Vulgaris; Adult; Humans; Isotretinoin; Tretinoin

The clinical pharmacokinetic profiles of two orally administered retinoids, isotretinoin and etretinate, are discussed and compared. The pharmacokinetic profile of isotretinoin is predictable and can be described using linear pharmacokinetic theory. The drug is rapidly absorbed following oral administration, is highly bound to plasma protein, and is metabolized to 4-oxo-isotretinoin. The apparent half-lives of elimination of isotretinoin and 4-oxo-isotretinoin following the oral administration of isotretinoin range from 10 to 20 hours and 24 to 29 hours, respectively. Steady-state pharmacokinetic profiles in patients are consistent with the single-dose pharmacokinetics in normal subjects. Following oral administration, etretinate undergoes significant first-pass biodegradation to its corresponding carboxylic acid; the acid appears rapidly in the circulation, often earlier than the parent drug, and its plasma concentration is usually comparable to, or greater than, that of the parent drug. The apparent elimination rates of drug and metabolite are similar (6-13 hours) following a single dose, suggesting that metabolite elimination may be formation-rate limited. During multiple dosing of etretinate, a very slow terminal elimination phase is observed which is not detected after single-dose administration. The prolonged half-life of this phase suggests accumulation in a deep tissue compartment. Differences between the two retinoids reflect their differing physicochemical properties.

Topics: Acne Vulgaris; Etretinate; Humans; Isomerism; Isotretinoin; Kinetics; Male; Tretinoin

Topics: Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide; Dermabrasion; Humans; Sebum; Tretinoin

Topics: Acne Vulgaris; Clindamycin; Erythromycin; Family Practice; Female; Humans; Male; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Darier Disease; Humans; Ichthyosis; Psoriasis; Skin Diseases; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Adult; Female; Humans; Male; Tretinoin

Topics: Acne Vulgaris; Adult; Gram-Negative Aerobic Bacteria; Humans; In Vitro Techniques; Isotretinoin; Propionibacterium acnes; Skin; Tretinoin

Topics: Acne Vulgaris; Animals; Cocarcinogenesis; Etretinate; Humans; Immunity; Isomerism; Isotretinoin; Keratosis; Polyamines; Psoriasis; Skin; Skin Diseases; Teratogens; Tretinoin; Triglycerides; Vitamin A

Sixteen patients with care acne conglobata, acne fulminans, acme tetrade were treated orally with 13-cis-retinoic acid, 1-2 mg/kg body weight for 12 weeks. A maintenance dose of 0.5 mg/kg in ten cases and the use of no further medication in six other cases for an additional 12 weeks followed. A 40% potassium iodide ointment was used on the upper back under occlusive dressing conditions to induce an inflammatory reaction. Four inflammatory parameters were assessed in all subjects before and during oral treatment: erythema (0-2+), edema (0-2+), papules (numbers), and pustules (numbers). All patients showed excellent improvement. Additionally, the inflammatory reaction in all patch-tests was significantly reduced: erythema from 1.13 to 0.34 (P less than or equal to 0.01); edema from 1.06 to 0.25 (P less than or equal 0.0005); papules from 6.75 to 1.86 (P less than or equal to 0.01); and pustules from 10.44 to 1.56 (P less than or equal to 0.0025). We suggest that 13-cis-retinoic acid acts as a strong anti-inflammatory agent in addition to its known function as a sebostaticum.

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Inflammatory Agents; Humans; Inflammation; Isotretinoin; Male; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Drug Evaluation; Female; Humans; Isomerism; Isotretinoin; Lipids; Male; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Etretinate; Female; Humans; Isotretinoin; Male; Maternal-Fetal Exchange; Pregnancy; Sex Factors; Tretinoin

Topics: Acne Vulgaris; Humans; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Female; Humans; Male; Middle Aged; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adrenal Cortex Hormones; Anti-Bacterial Agents; Benzoyl Peroxide; Contraceptives, Oral; Humans; Keratolytic Agents; Tetracycline; Tretinoin; Zinc

Topics: Acne Vulgaris; Administration, Topical; Animals; Humans; Light; Salicylates; Tretinoin

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Adolescent; Adult; Androgen Antagonists; Benzoyl Peroxide; Erythromycin; Female; Humans; Male; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Humans; Propionibacterium acnes; Tretinoin

Topics: Acne Vulgaris; Benzoyl Peroxide; Erythromycin; Humans; Propionibacterium acnes; Sebaceous Glands; Sebum; Tetracycline; Tretinoin

Acne vulgaris is a common skin disorder that is socially disabling to some degree in the majority of adolescents. Effective management of this disease has two major components: a strong physician-patient relationship and a sound medical regimen. The former is necessary to foster patient compliance with the long-term therapeutic regimen required, as well as to reduce the disease's potential for emotional scarring. The rational usage of the various topical and systemic medications available will serve to decrease the frequency and severity of exacerbations as well as to minimize possible scarring. Specific recommendations as to moisturizers and cosmetics are included.

Topics: Acne Vulgaris; Benzoyl Peroxide; Cosmetics; Erythromycin; Humans; Physician-Patient Relations; Salicylates; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Humans; Psoriasis; Skin Diseases; Tretinoin; Vitamin A

A new, very effective method of treating severe forms of acne (papuplopustular, conglobate, fulminating and tetrad) is the oral administration of 13-cis-retinoic acid. The results described by Peck et al. (1979) in 14 patients are demonstrated in detail in 18 patients. In the initial therapy 1 to 2 mg/kg body weight were administered daily for 12 weeks without any other local or systemic treatment. In the second phase of the study half the patients continued treatment with 0.5 mg/kg body weight 13-cis-retinoic acid, the other half remaining without any further therapy. All inflammatory lesions healed after 12-16 weeks, sebum production was largely reduced. 13-cis-retinoic acid represents a remarkable turn in the treatment of most severe acne.

Topics: Acne Vulgaris; Adolescent; Adult; Drug Administration Schedule; Humans; Male; Tretinoin

This study shows that severe acne is characterized by numerous inflammatory parameters. The group of acne tetrad patients differed from those with conglobate acne in many laboratory measurements. The treatment with 13-cis-retinoic acid was well tolerated by all patients. Sebum suppression and an exfoliative cheilitis occurred in all patients, but no headache and no loss hair. Numerous previously pathological blood chemical values were normalized during the treatment. Transaminases, alkaline phosphatase, triglycerides and total cholesterol did not rise noticeably, trichological and spermatological parameters were not affected by 13-cis-retinoic acid. In an in vivo epicutaneous potassium iodide inflammation model, it was possible to demonstrate for the first time the anti-inflammatory action of 13-cis-retinoic acid.

Topics: Acne Vulgaris; Adolescent; Adult; Blood Cell Count; Humans; Lipids; Male; Sebum; Tretinoin

Few studies of topical treatment in acne stand up to modern scientific requirements, and several of those which do suggest that some modalities make acne worse rather than better. There is evidence that sulphur, soap, and light treatment prolong the course of illness. This also applies to some components of the vehicles used for acne medicaments. Fortunately, traditional treatment can be abandoned in favour of the superior benzoyl peroxide and retinoic acid.

Topics: Acne Vulgaris; Administration, Topical; Animals; Emulsions; Humans; Keratolytic Agents; Rabbits; Salicylates; Soaps; Sulfur; Sunlight; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Benzoyl Peroxide; Child; Clindamycin; Erythromycin; Female; Humans; Male; Sulfamethoxazole; Sulfur; Tetracyclines; Tretinoin; Trimethoprim

The effects of 13-cis-retinoic acid, which is clinically very effective in the treatment of severe acne, on sebaceous glands in humans was studied by means of histology, planimetry, and autoradiography. Histologically and planimetrically, one finds a marked decrease of size of sebaceous glands of up to 90% of the pretreatment values after 12 weeks of treatment. Additionally, the ratio of the so-called "differentiating cell pool (DCP)" vs. the so-called "undifferentiating cell pool (UCP)" changed from 2:1 to 1:7, probably indicating a disturbance of differentiation (lipid-production) of sebocytes. The labeling index of sebocytes also regressed significantly under therapy with 13-cis-retinoic acid.

Topics: Acne Vulgaris; Adolescent; Adult; Humans; Male; Sebaceous Glands; Tretinoin

Topics: Acne Vulgaris; Adolescent; Humans; Tretinoin; Vitamin A

Acne vulgaris is one of the most widespread of all diseases and is frequently the object of treatment in general and specialist medical practice. New insights into the pathophysiology of acne show that the most important therapeutic principle is suppression of the propionibacteria in the pilosebaceous duct since these bacteria have a key role in the genesis of the comedo and of inflammatory acne efflorescences. Experimental findings are shown which prove the value of a local treatment with antibiotics and ethanol-containing masks. The second therapeutic principle is "keratolytic" therapy. Retinoic acid, benzoyl peroxide and salicylic acid are in the forefront here. The third therapeutic principle is the reduction of seborrhea. Benzoyl peroxide is especially suitable for local treatment. Differential diagnosis of acne vulgaris and additional possibilities of treatment in problem cases are dealt with.

Topics: Acne Vulgaris; Adolescent; Adult; Androgen Antagonists; Anti-Bacterial Agents; Dermatitis, Seborrheic; Diagnosis, Differential; Humans; Tretinoin

The anti-inflammatory effect of the new topical corticosteroid fluocortin butyl ester is approximately equal to that of hydrocortisone acetate but it has the advantage that systemic side-effects are lacking. Vitamin A acid and benzoyl peroxide have brought significant advances in the topical treatment of acne. For the treatment of chloasma and other hyperpigmentations the combination of vitamin A acid and hydroquinone with a corticoid is considerably more effective than any of the single components alone. Povidone-iodine with its extraordinarily low sensitization rate has proved useful for external antimicrobial treatment. Extensive or multiple precancerous lesions are effectively treated with 5-fluorouracil. New hair growth can be induced in alopecia areata by the local application of DNCB.

Topics: Acne Vulgaris; Administration, Topical; Alopecia; Benzoyl Peroxide; Dinitrochlorobenzene; Fluocortolone; Fluorouracil; Humans; Hydroquinones; Pigmentation Disorders; Precancerous Conditions; Skin Diseases; Tretinoin

Fourteen patients with treatment-resistant cystic and conglobate acne were treated for four months with oral 13-cis-retinoic acid, a synthetic isomer of naturally occurring all-trans-retinoic acid. The average dose was 2.0 mg per kilogram per day. Thirteen patients experienced complete clearing of their disease; the other had 75 per cent improvement, as determined by the number of acne nodules and cysts present before and after therapy. Prolonged remissions, currently lasting as long as 20 months after discontinuation of therapy, have been observed in all 14 patients. Clinical toxicity was limited to the skin and mucous membranes in most patients and was dose dependent and rapidly reversible upon discontinuation of therapy. The mechanism of action of 13-cis-retinoic acid in the therapy of acne probably involves a direct inhibitory effect of the drug on the sebaceous gland.

Topics: Acne Vulgaris; Adolescent; Adult; Female; Humans; Isomerism; Lipids; Male; Remission, Spontaneous; Sebum; Time Factors; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Humans; Sebum; Skin; Tretinoin; Vitamin A

Multiple granulomata pyogenica are usually satellites of a primary lesion recently treated unsuccessfully. Disseminated pyogenic granulomas are very uncommon. In our case report, we describe a young man with six granulomata pyogenica over the chest, after treating his acne with tetracycline and vitamin A acid. In the discussion, we include infection, trauma and vitamin A acid as factors which can induce the vascular tumor in the region of a vascular dysplasia.

Topics: Acne Vulgaris; Adult; Granuloma; Humans; Male; Tetracycline; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Male; Peroxides; Tretinoin; Vitamin A

Various concentrations of vitamin A acid were applied to experimentally induced comedones. All concentrations produced non-cohesive hyperkeratinization, which loosened the cohesive horny mass induced by oleic acid and expelled it from the follicle within 7 days. The highest concentration (0.1%) produced the greatest degree of non-cohesive desquamation in the shortest time. In follicles treated with the acid, the cell membrane of horny cells was thin and ruptured easily to produce a non-cohesive debris. Desmosomes were scarce and desmosomal bodies (fusiform electron-dense bodies) and tight junctions between horny cells were not seen in follicles treated with the acid. The acid also produced hyperplasia of the epithelial wall and an apparently increased mitotic rate. A 0.025% concentration of the acid increased the number of membrane coating granules by about 70% in all regions of the follicle.

Topics: Acne Vulgaris; Animals; Cell Membrane; Desmosomes; Male; Microscopy, Electron; Rabbits; Skin; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Contraceptives, Oral; Humans; Resorcinols; Salicylates; Sulfur; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Ficusin; Humans; Information Services; Psoriasis; Tretinoin; Ultraviolet Therapy

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Benzoyl Peroxide; Clindamycin; Erythromycin; Humans; Tetracyclines; Tretinoin

Twelve patients (20 +/- 2 years) with acne vulgaris were treated orally with 20-30 mg/day tretinoin (vitamin A acid) over 90-300 days. Various laboratory tests were performed to rule out unwanted pharmacological side effects. Tretinoin therapy was well tolerated except for minor complaints of dryness around the mucous membranes of mouth and nose. The acne remained unchanged. All laboratory tests were unremarkable except for a significant rise of ejaculate volume. Other sperm parameters, trichological, ophthalmological as well as blood and urine analyses showed no measurable effects of tretinoin therapy.

Topics: Acne Vulgaris; Acrosin; Adult; Blood Cell Count; Hair; Humans; Intraocular Pressure; Male; Skin; Spermatozoa; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Adult; Aluminum Hydroxide; Drug Combinations; Female; Humans; Male; Methylprednisolone; Neomycin; Random Allocation; Suspensions; Tretinoin

A clinical trial using Airol cream (retinoic acid cream 0.05%), Panoxyl-5 and Panoxyl-10 (benzoyl-peroxide alcoholic gel 5% & 10%) in combination and alone as topical applications for 10 weeks was carried out on 150 ambulatory patients with acne vulgaris. The results based on efficacy, drug tolerance and treatment duration show that the combined use of Panoxyl and Airol is superior to the use of either drug alone and that the combination of Airol cream (0.05%) in the morning and Panoxyl gel (5%) before retiring was the most satisfactory.

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Child; Dermatitis, Contact; Drug Hypersensitivity; Drug Therapy, Combination; Female; Humans; Male; Ointments; Peroxides; Tretinoin

Blepharoconjunctivitis developed as a side-effect of treatment of patients with basal cell carcinomas, keratinizing dermatoses, and cystic acne with oral 13-cis-retinoic acid. Forty-two of the 97 dermatologic patients had signs and symptoms of blepharoconjunctivitis that were dose related and abated one week after discontinuation of the medication. About half of the patients had a history of similar symptoms prior to treatment. Staphylococcus aureus was present in eye cultures of 73% to 79% of the patients, whether symptomatic or not. Patients whose clinical appearance was that of staphylococcal blepharoconjunctivitis and whose cultures grew S aureus were successfully treated with topical erythromycin ointment to the lids even while being treated with the 13-cis-retinoic acid.

Topics: Acne Vulgaris; Blepharitis; Carcinoma, Basal Cell; Conjunctivitis; Erythromycin; Eyelid Diseases; Humans; Keratosis; Skin Diseases; Skin Neoplasms; Staphylococcal Infections; Tretinoin

Topics: Acne Vulgaris; Adolescent; Humans; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Humans; Ointments; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Oral; Carcinoma, Basal Cell; Darier Disease; Drug Evaluation; Humans; Ichthyosis; Pityriasis Rubra Pilaris; Skin Neoplasms; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Adrenal Cortex Hormones; Adult; Benzoyl Peroxide; Child; Estrogens; Humans; Tetracyclines; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Child; Female; Humans; Pregnancy; Teratogens; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Chlorhexidine; Drug Therapy, Combination; Erythromycin; Female; Humans; Male; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Child; Female; Humans; Male; Middle Aged; Time Factors; Tretinoin; Vitamin A

While there is no single treatment plan that will work for every patient, acne can be controlled and long-term scarring can be minimized. Treatment must be individualized. Remember, there may be a "flare" when intensive therapy begins. Useful treatment methods include ultraviolet light, cleansers and soaps, peeling and drying agents, benzoyl peroxide preparations, abrasive soaps and scrubs, retinoic acid and oral antibiotics. The therapeutic choice depends upon the extent and severity of the disease.

Topics: Acne Vulgaris; Adolescent; Benzoyl Peroxide; Humans; Keratolytic Agents; Soaps; Tetracycline; Tretinoin; Ultraviolet Therapy

According to the results obtained in a recent clinical trial over a four-year period retinoic acid represents the most effective single agent available for the topical management of acne vulgaris. Retinoic acid yields impressive therapeutic results not only in patients with manifest acne, but, provided it is applied early enough, it is also effective in preventing the severe inflammatory manifestations of this disease. In medium to severe cases of inflammatory acne, topical retinoic acid therapy should be combined with a low-dose, long-term systemic tetracycline regimen. The course of treatment may extend over months or years, depending on the severity of the condition. Particularly patients in the acne-prone age group are candidates for long-term therapy. Retinoic acid therapy, alone or in combination with tetracyclines, proved far superior to conventional regimens with respect to the effective treatment and prophylaxis of acne.

Topics: Acne Vulgaris; Adolescent; Evaluation Studies as Topic; Female; Humans; Middle Aged; Ointments; Tetracyclines; Time Factors; Tretinoin; Vitamin A

The administration of anti-androgens brings favourable results especially in such skin diseases showing unsatisfactory therapeutic results, i.e. all severe forms of acne, seborrhoea, androgenic alopecia and hirsutism. Exact knowledge of the oestrogen and gestagen effect is essential. Also of fundamental importance is the observation and consideration of side effects besides the contraceptive efficacy and therapeutic results in dermatology.

Topics: Acne Vulgaris; Alopecia; Androgen Antagonists; Contraceptives, Oral; Contraceptives, Oral, Hormonal; Dermatitis, Seborrheic; Female; Hirsutism; Humans; Hypertrichosis; Skin Diseases; Tetracycline; Tretinoin

Sodium sulfacetamide, penetrating antibacterial, in combination with hydrocortisone and sulfur, has enjoyed twenty years of remarkable safety, with outstanding efficacy and patient acceptance, in the prescription treatment of pustular acne and severe, refractory seborrheic dermatitis. Recently, this combination has been reported to be highly effective concomitant therapy for perioral dermatitis. Almost paradoxically, it achieves these desired goals without the excessive erythema and discomforting irritation associated with retinoic acid and benzoyl peroxide.

Topics: Acne Vulgaris; Administration, Topical; Anti-Inflammatory Agents; Benzoyl Peroxide; Dermatitis, Seborrheic; Drug Combinations; Humans; Hydrocortisone; Rosacea; Sulfacetamide; Sulfur; Tretinoin

Seven important therapeutic measures in managing acne are described, for the treatment of the 7 types of acne. These therapeutic measures are retinoic acid, benzoyl peroxide gel, topical antibiotics, oral antibiotics, intralesional corticosteroids, liquid nitrogen and oral corticosteroids.

Topics: Acne Vulgaris; Benzoyl Peroxide; Clindamycin; Erythromycin; Humans; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Estrogens; Female; Humans; Tetracycline; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Female; Humans; Male; Tampons, Surgical; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Drug Evaluation; Humans; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Anti-Bacterial Agents; Benzoyl Peroxide; Humans; Salicylates; Tretinoin

Topics: Acne Vulgaris; Humans; Tretinoin; Vitamin A

Hormonal factors, particularly androgens, appear to be important in the pathogenesis of acne vulgaris. The sebaceous glands in acne are more sensitive to normal blood levels of androgens, and are stimulated to produce more sebum. Corynebacterium acnes in the sebaceous follicles act on triglycerides in the sebum to form free fatty acids which might alter the process of keratinization in the follicular canal. A microcomedo is formed which can progress to the clinical lesions of acne. Sebum and its components may also be inflammatory if released into the skin. There are, however, still a number of unanswered questions relating to acne pathogenesis. Currently, therapy of acne vulgaris revolves around topical benzoyl peroxide and retinoic acid and systemic tetracyclines. Benzoyl peroxide and tetracyclines are antibacterial while retinoic acid is comedolytic. Because of these different actions, combined therapy appears to be more effective (benzoyl peroxide and/or tetracyclines together with retinoic acid). Topical antibiotics show promise as new therapeutic agents.

Topics: Acne Vulgaris; Androgens; Benzoyl Peroxide; Corynebacterium; Drug Combinations; Humans; Sebaceous Glands; Tetracyclines; Tretinoin; Triglycerides

A report is made on 80 male patients aged 19-25 and suffering from common acne, who were treated with vitamin A acid (Eudyna) partly as inpatients and partly as outpatients. All stages were present from acne comedonica to acne conglobata. The preparation was available in the form of cream and jelly, each containing 0.05% tretinoin. As a rule, the drug was applied once daily. At the end of the tretinoin treatment lasting for a maximum of 9 weeks, a decrease in comedones of more than 90% is reported. The tolerance of Eudyna was seen to be good to very good in more than two thirds of the patients.

Topics: Acne Vulgaris; Administration, Topical; Adult; Drug Therapy, Combination; Humans; Male; Retrospective Studies; Tetracycline; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Female; Fetus; Humans; Pregnancy; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Chloramphenicol; Diagnosis, Differential; Humans; Oxytetracycline; Tetracyclines; Tretinoin

Topics: Acne Vulgaris; Humans; Skin Diseases; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Drug Evaluation; Female; Humans; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Adult; Benzoyl Peroxide; Drug Therapy, Combination; Estrogens; Humans; Infant, Newborn; Resorcinols; Salicylates; Sulfur; Tretinoin

Topics: Acne Vulgaris; Adolescent; Adult; Anti-Bacterial Agents; Child; Child, Preschool; Female; Humans; Pyoderma; Skin; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Drug Evaluation; Humans; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Benzoyl Peroxide; Drug Therapy, Combination; Erythromycin; Female; Humans; Peroxides; Tretinoin; Vitamin A

Structural differences between untreated and tretinoin treated acne, uniquely evident with the scanning electron microscope, provide insight into the disease and its response to the drug. Early tretinoin therapy is characterized by the appearance of loosely adherent, parakeratotic cells which account for comedo expulsion and a disrupted skin surface. Persistence of the follicular and comedonal alterations account for the prophylactic value of long-term therapy. Meanwhile, the structure of the stratum corneum returns toward normal, with the clinical accommodation to the topical tretinoin.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Humans; Male; Microscopy, Electron, Scanning; Skin; Tretinoin; Vitamin A

This is the first American report, to our knowledge, of a case of acne aestivalis, which occurred in a woman with a recurrent acneform eruption in summertime. The histopathologic sequence was very similar to that found in cases of steroid acne; namely, local necrosis of the follicular epithelium was followed by the formation of a comedo. No cause was found. Treatment with tretinoin brought about regression of the lesions.

Topics: Acne Vulgaris; Administration, Oral; Administration, Topical; Adult; Biopsy; Female; Humans; Periodicity; Radiation Dosage; Seasons; Skin; Tetracycline; Tretinoin; Ultraviolet Therapy

Topics: Acne Vulgaris; Humans; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Animals; Cricetinae; Humans; Mice; Rats; Teratogens; Tretinoin; Vitamin A

Vitamin A acid represents the most effective therapeutic agent available for the topical treatment of acne vulgaris. This is also borne out by the results obtained in 152 patients over a two-year period. Clinical improvement is striking, long lasting remissions can be maintained by continuous treatment, and there appears to be an acceleration of the natural course to spontaneous remission of disease activity. Patients beyond their teens are more likely to remain symptom-free after adequate treatment than younger patients who may require prolonged maintenance treatment. Special attention is given to the appropriate care for Vitamin A acid treated skin and the general management of these patients is outlined. It is stressed that the patient be instructed, in detail, about the course of treatment and the necessity of staying under observation by an experienced dermatologist.

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Child; Drug Therapy, Combination; Female; Germany, West; Humans; Male; Middle Aged; Recurrence; Retrospective Studies; Seasons; Tetracyclines; Tretinoin; Ultraviolet Rays; Vitamin A

Topics: Acne Vulgaris; Animals; Congresses as Topic; Humans; In Vitro Techniques; Neoplasms, Experimental; Skin Diseases; Skin Neoplasms; Switzerland; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Adult; Humans; Tretinoin; Vitamin A

Topics: Acne Vulgaris; Adolescent; Adrenal Cortex Hormones; Anti-Bacterial Agents; Humans; Keratins; Malassezia; Propionibacterium acnes; Staphylococcus; Tretinoin

Topics: Acne Vulgaris; Administration, Topical; Adolescent; Benzoyl Peroxide; Corynebacterium Infections; Drug Therapy, Combination; Fatty Acids; Fatty Acids, Nonesterified; Humans; Peroxides; Propionibacterium acnes; Skin; Tetracycline; Tretinoin; Vitamin A