tretinoin and clindamycin-phosphate

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

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

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 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

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

A derivative spectrophotometric method was proposed for the simultaneous determination of clindamycin and tretinoin in pharmaceutical dosage forms. The measurement was achieved using the first and second derivative signals of clindamycin at (1D) 251 nm and (2D) 239 nm and tretinoin at (1D) 364 nm and (2D) 387 nm.The proposed method showed excellent linearity at both first and second derivative order in the range of 60-1200 and 1.25-25 μg/ml for clindamycin phosphate and tretinoin respectively. The within-day and between-day precision and accuracy was in acceptable range (CV<3.81%, error<3.20%). Good agreement between the found andadded concentrations indicates successful application of the proposed method for simultaneous determination of clindamycin and tretinoin in synthetic mixtures and pharmaceutical dosage form.

Topics: Clindamycin; Dosage Forms; Spectrophotometry; 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

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

A new HPLC method based on reverse phase separation and photodiode-array detection has been developed for the simultaneous determination of tretinoin and clindamycin phosphate, and their degradation products in topical formulations. The method has been shown to be stability indicating, accurate, and precise for two different formulation vehicles. Separation was achieved on a reverse phase C18 column (Lichrospher, RP18, 5 microm, 25 cm x 4.6 mm ID, Phenomenex, USA) using a simple gradient with aqueous-acetonitrile and aqueous-methanol mobile phases. The method recovery averaged 100.3% for tretinoin and 99.6% for clindamycin phosphate at a concentration range between 80% and 120% of the label claim. The method can be applied to assess the stability of tretinoin and clindamycin phosphate in pharmaceutical formulations containing tretinoin and clindamycin phosphate individually or in combination as active drugs.

Topics: Administration, Topical; Chemistry, Pharmaceutical; Chromatography, High Pressure Liquid; Clindamycin; Drug Combinations; Drug Stability; Humans; In Vitro Techniques; 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

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