isotretinoin and Cheilitis

Isotretinoin is a very effective medication for the treatment of severe recalcitrant acne. However, its use is associated with many side effects, some of which can be very serious. The most important issue is its teratogenicity, which has resulted in new pregnancy prevention policies and programmes implemented by the manufacturer. Recently, the association of isotretinoin with depression has been recognised and new guidelines have been adopted for this possible side effect. The most common adverse events, observed during treatment, are mucocutaneous and ophthalmological. In addition, laboratory abnormalities and effects in the nervous, musculoskeletal, gastrointestinal, pulmonary and other systems have been described.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Cheilitis; Depression; Humans; Isotretinoin; Practice Guidelines as Topic

Systemic treatment is required in patients with moderate-to-severe acne, especially when acne scars start to occur. Antibiotics with anti-inflammatory properties, such as tetracyclines (oxytetracycline, tetracycline chloride, doxycycline, minocycline and limecycline) and macrolide antibiotics (erythromycin and azithromycin) are the agents of choice for papulopustular acne, even though the emerging resistant bacterial strains are minimizing their effect, especially regarding erythromycin. Systemic antibiotics should be administered during a period of 8-12 weeks. In severe papulopustular and in nodulocystic/conglobate acne, oral isotretinoin is the treatment of choice. Hormonal treatment represents an alternative regimen in female acne, whereas it is mandatory in resistant, severe pubertal or post-adolescent forms of the disease. Compounds with anti-androgenic properties include estrogens combined with progestins, such as ethinyl estradiol with cyproterone acetate, chlormadinone acetate, desogestrel, drospirenone, levonogestrel, norethindrone acetate, norgestimate, and other anti-androgens directly blocking the androgen receptor (flutamide) or inhibiting androgen activity at various levels, corticosteroids, spironolactone, cimetidine, and ketoconazole. After 3 months of treatment control of seborrhea and acne can be obtained. Low-dose corticosteroids (prednisone, prednisolone, or dexamethasone) are indicated in patients with adrenal hyperandrogenism or acne fulminans. New developments and future trends represent low-dose long-term isotretinoin regimens, new isotretinoin formulations (micronized isotretinoin), isotretinoin metabolites, combination treatments to reduce toxicity, insulin-sensitizing agents, 5alpha-reductase type 1 inhibitors, antisense oligonucleotide molecules, and, especially, new anti-inflammatory agents, such as lipoxygenase inhibitors.

Topics: Acne Vulgaris; Administration, Oral; Androgen Antagonists; Anti-Bacterial Agents; Cheilitis; Clindamycin; Cyproterone; Forecasting; Humans; Isotretinoin; Severity of Illness Index; Tetracyclines

Isotretinoin (Accutane, Roche Laboratories Inc, Nutley, NJ) is an important drug, not only for the treatment of severe acne, but also for other diagnoses and in chemoprevention settings. Because the use of isotretinoin is increasing, it is important for physicians to be aware of the adverse events, toxicities, and management issues related to its use. The most important issue is that of congenital defects, which has resulted in new pregnancy prevention policies and programs implemented by the manufacturer. A relatively new concern is that of depression associated with isotretinoin use, also resulting in new policies placed by the manufacturer and the FDA. The most common adverse effects observed during treatment are mucocutaneous and ocular in nature, but laboratory abnormalities and effects in the nervous, musculoskeletal, gastrointestinal, pulmonary, hematologic, and other systems are also described. Additionally, potential drug interactions, follow-up, and toxicity prevention measures are discussed.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Cheilitis; Dermatologic Agents; Drug Interactions; Eye Diseases; Humans; Isotretinoin; Liver Function Tests; Mental Disorders; Mouth Mucosa; Musculoskeletal Diseases

Plane warts are a common therapeutic problem. Our aim was to assess the efficacy and safety of oral versus topical isotretinoin in the treatment of plane warts.. Forty patients with multiple plane warts were randomized into two groups. Group A was treated with oral isotretinoin capsules in the dose of 0.5 mg/kg/d and Group B with topical isotretinoin 0.05% in gel formulation once daily at night. Treatment was given to the patients for 3 months or until the complete clearance of lesions, whichever was earlier. Patients with complete response were followed up monthly for 4 months to record the relapse rate.. Results were analyzed in 16 patients of Group A and 13 patients of Group B. At the end of 3 months of therapy, 11 (69%) patients in Group A had complete remission whereas five (31%) had partial remission. In Group B, at the end of study, five (38%) patients had complete remission and six (46%) had partial remission, whereas two patients had no remission. The difference was statistically significant between two groups; P < 0.0001. The most common side effect in Group A was cheilitis. In Group B, five patients had to be dropped because they developed severe erythema and scaling.. Oral isotretinoin showed better and earlier response than topical isotretinoin. Oral isotretinoin should definitely be given a trial particularly in cases of multiple facial warts before trying various destructive procedures.

Topics: Administration, Cutaneous; Administration, Oral; Adult; Cheilitis; Dermatologic Agents; Erythema; Facial Dermatoses; Female; Humans; Isotretinoin; Male; Middle Aged; Remission Induction; Warts; Young Adult

Acne treatment depends on whether patents have a mild, moderate, or severe type of acne. The aim of this study was to compare the using of Isotretinoin (Rokutan) with and without oral vitamin E in treating acne. This study was performed on 60 patients on 0.5 mg/kg/day isotretinoin treatment for 6 months. The first group received 800 IU day(-1) Vit E during treatment and the second group recieved 800 Iu day(-1) cod liver oil capsules. All patients were observed for the complications at 1th, 4th and 6th weeks during treatment. Cheilitis was the most common side effect among these patients (69%). Epistaxis was the second side effect in both groups (22%). Other side effects were xerosis, pruritus, epigastric pain and nail fragility. The frequency and the severity of complications were less common at 4th and 6th weeks of treatment. Isotretinoin is a useful and effective drug in treating severe and treatment-resistance acne lesions.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Capsules; Cheilitis; Chi-Square Distribution; Cod Liver Oil; Dermatologic Agents; Epistaxis; Female; Humans; Isotretinoin; Male; Severity of Illness Index; Time Factors; Treatment Outcome; Vitamin E; Young Adult

Valproic acid (VPA), an inhibitor of histone deacetylases, inhibits the growth of leukemia cells and induces their differentiation in vitro. In the present study, VPA in combination with two differentiating agents, 13-cis retinoic acid and 1,25-dihydroxyvitamin D3, was given to 19 previously untreated patients with MDS or CMML. Eight patients had to discontinue treatment before week 16 due to toxicity. According to international working group criteria, three patients (16%) responded to treatment. No correlation between VPA serum level, histone acetylation or clinical response was observed.

Topics: Acetylation; Aged; Aged, 80 and over; Calcitriol; Cheilitis; Chemical and Drug Induced Liver Injury; Drug Therapy, Combination; Fatigue; Histones; Humans; Isotretinoin; Middle Aged; Myelodysplastic Syndromes; Pneumonia; Protein Processing, Post-Translational; Treatment Outcome; Valproic Acid

Topics: Acne Vulgaris; Administration, Oral; Adult; Blepharitis; Cheilitis; Conjunctivitis; Dermatologic Agents; Drug Eruptions; Drug Monitoring; Epistaxis; Female; Humans; Hypertriglyceridemia; Ichthyosis; Isotretinoin; Keratolytic Agents; Male; Pain; Pruritus; Severity of Illness Index; Treatment Outcome; Xerostomia

One hundred and seventy-five children with Stage 3 or 4 neuroblastoma who had obtained a good response to conventional therapy were randomly allocated to 13-Cis retinoic acid at a dose of 0.75 mg/kg/day or placebo for up to 4 years. Toxicity was mild but no advantage in event-free survival was shown for the children receiving retinoic acid.

Topics: Adolescent; Adult; Antineoplastic Agents, Alkylating; Cheilitis; Child; Child, Preschool; Dose-Response Relationship, Drug; Double-Blind Method; Follow-Up Studies; Humans; Infant; Isotretinoin; Melphalan; Neoplasm Staging; Neoplasm, Residual; Neuroblastoma; Skin Diseases; Survival Analysis; Survival Rate; Treatment Outcome

Retinoids are under intensive study for the treatment and prevention of cancer. Substantial dose-related toxicities of retinoids are a major obstacle to this work. In a recent retrospective analysis of combined 13-cis-retinoic acid (13cRA) and alpha-tocopherol (AT) in myelodysplasia, 13cRA toxicity was reduced significantly and 13cRA activity was enhanced. These results suggested the need for prospective testing of this new combination. This trial tested the hypotheses that At can reduce toxicity of high-dose 13cRA and does not interfere with 13cRA absorption/activity as reflected by reduced 13cRA serum levels.. This was a phase I trial design in which patients received fixed-dose 13cRA (100 mg/m2/d) plus escalating-dose AT (beginning at 800 IU/d, increased 400 IU/d each month until 2000 IU/d). We collected toxicity data every four weeks from self-report forms, clinical examinations and laboratory studies. AT effects on 13cRA toxicity were determined by comparing maximum toxicity at lowest AT dose with that at highest AT dose. We also measured serum levels of both agents every four weeks.. Of the 45 patients registered, 36 had cancer (active or prior history), 9 had premalignant lesions. Thirty-nine patients could be evaluated for initial-course toxicity; 31 for final course toxicity. Median time on treatment (all patients) was four months (range, 1-9 months); a total of 223 month-long courses of treatment were given. Eighteen percent of patients (7/39) developed grade 3 or 4 toxicity in the initial course. The rates of increase and decrease in 13cRA toxicity associated with increasing AT doses were similar: 36% decreased (11/31), 32% increased (10/31) (P = 0.84). At did not reduce 13cRA serum levels. After initial increases of mean AT plasma levels (17.9 micrograms/ ml at baseline to 45.4 micrograms/ml after first four-week course), subsequent AT plasma increases (< 2-fold) did not keep pace with increased AT doses (2-3-fold). No major activity occurred in the 21 patients with active refractory cancer. The complete response rate in patients with premalignant head-and-neck or lung lesions was 77.8% (7/9), which included two patients previously refractory to 13cRA alone.. Although escalating doses of AT did not reduce 13cRA toxicity, the rate of initial-course (including 800 IU/d of AT) high-grade toxicity was substantially lower than that typical of high-dose 13cRA-alone and similar to that typical of low-dose 13cRA-alone. Indeed, a trial of 13cRA-alone followed by 13cRA plus AT may have detected a significant toxicity difference. We did not design such a trial out of ethical concern for known side effects of high-dose 13cRA. The increase in AT serum levels was not proportional with increasing doses of AT, which may explain the lack of a dose-response effect of AT on 13cRA toxicity. Previous trials have established that 13cRA has an approximate 10% complete response rate in oral premalignancy. Our small trial's 77.8% complete response rate in premalignant lesions suggests that AT may enhance 13cRA clinical activity. Future trials of 13cRA plus AT are needed to define this combinations toxicity profile, clinical activity and pharmacokinetics.

Topics: Adult; Aged; Alanine Transaminase; Alkaline Phosphatase; Anticarcinogenic Agents; Antineoplastic Agents; Biomarkers; Cheilitis; Chemical and Drug Induced Liver Injury; Conjunctivitis; Drug Eruptions; Female; Humans; Hypertriglyceridemia; Isotretinoin; Leukoplakia, Oral; Lung Diseases; Male; Middle Aged; Neoplasms; Pain; Precancerous Conditions; Treatment Outcome; Vitamin E

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

Seborrheic dermatitis is a common, chronic, and recurrent inflammatory skin disease. There are few studies on oral isotretinoin in the treatment of seborrheic dermatitis. The aim of this research was to analyze the efficacy and safety of oral isotretinoin in the treatment of patients with moderate to severe seborrheic dermatitis.. This was a retrospective study. All included patients were diagnosed as moderate to severe seborrheic dermatitis and treated with oral isotretinoin from January 2019 to December 2020. Symptom Scale of Seborrheic Dermatitis (SSSD) was used to evaluate the overall severity status of disease.. A total of 48 patients with moderate to severe seborrheic dermatitis were enrolled, of which 26 patients were treated with oral isotretinoin at a dose of 20 mg/day, and 22 patients were treated with oral isotretinoin at a dose of 10 mg/day. The duration of treatment was 2.42 ± 0.98 months (range: 2-6 months). The absolute SSSD values were 10.63 ± 1.02 for all 48 patients, 10.95 ± 1.15 and 10.30 ± 1.11 for patients with a dose of 20 and 10 mg/day, respectively. At the endpoint, there were no significant difference in SSSD values between the two groups (2.21 ± 0.24 vs. 2.35 ± 0.46, P = 0.18). The patients were satisfied with the two treatment schemes, and the difference was not statistically significant (P = 0.78). The most common side effect was cheilitis; however, no serious adverse events occurred in either group.. When considering efficacy and safety, oral isotretinoin can be used to treat patients with moderate to severe seborrheic dermatitis.

Topics: Cheilitis; Dermatitis; Dermatitis, Seborrheic; Humans; Isotretinoin; Retrospective Studies

Topics: Cheilitis; Dermatitis, Allergic Contact; Humans; Hydrocortisone; Isotretinoin; Lip; Lip Neoplasms

Cheilitis is the most common mucocutaneous side effect of isotretinoin (ISO). Dexpanthenol (DXP) increases fibroblast proliferation and re-epithelialization in wound healing. We aimed to investigate the effect of DXP-mesotherapy in ISO-induced cheilitis in this study.. This study was conducted on patients who had been using ISO (0.5-1 mg/kg/day) for at least 2 months. Twenty-five patients who administered DXP-mesotherapy (mesotherapy group) and 33 patients without the procedure (control group, only ointment) participated in this study. All patients were prescribed only hamamelis virginiana distillate in ointment form as a lip balm. The efficacy of the treatment was interpreted by the change in lip balm use frequency, quality of life, and Isotretinoin Cheilitis Grading Scale (ICGS).. There was a statistically significant decrease in all ICGS-subgroups scores in the mesotherapy group after 1 month compared with the baseline (p = <0.001), although in the controls, erythema, crust, and fissure scores significantly increased (p = 0.001, p = 0.002).While there was no difference between the groups in terms of ICGS total scores at baseline, there was a significant difference after 1 month in favor of the mesotherapy group (p < 0.001). In the mesotherapy group, lip balms were needed significantly less frequently and there was a significant improvement in quality of life compared with both the control group and at baseline after 1 month (both; p < 0.001). On the other hand, the control patients suffered more from cheilitis and dryness than at baseline (p < 0.001).. Dexpanthenol-mesotherapy seems to be a safe, and so effective method in management of ISO-related cheilitis.

Topics: Cheilitis; Humans; Isotretinoin; Lip; Mesotherapy; Ointments; Quality of Life

Rosacea is a chronic inflammatory disorder that affects up to 10% of the population. Standard treatments include topical azelaic acid and metronidazole or systemic tetracyclines. Isotretinoin has generally been restricted to severe disease, often at a dose of 0.5-1.0 mg/kg/day.. Retrospective review of open-label isotretinoin (initial dose 20 mg/day, with dose adjustments according to response), in patients with mild to moderate papulopustular rosacea.. Altogether 52 patients (33 women), mean age 48 years (range 18-86) were treated with isotretinoin over a 5-year period. All patients were commenced on 20-mg isotretinoin/day which was reduced to 10-20 mg once to five times a week (equivalent to 5 mg/day) in 67%, but increased in 15% (who all had additional acne) to 30-40 mg/day. In terms of dose/kg/day, 29% received ≤ 0.1 mg/kg/day, 46% received 0.11-0.25 mg/kg/day and 10% received > 0.5 mg/kg/day. Treatment was continued for 57 weeks (range 9-223). Six patients (12%) did not attend follow up. Of the remainder, in 91% (42/46) the rosacea had cleared or was excellent. One patient stopped isotretinoin because of its adverse effects. Two-fifths (44%) suffered no adverse effect. The most common side-effect was cheilitis in half (52%), which was mild in all but one patient.. Very low-dose isotretinoin (e.g., 10-20 mg once to five times a week, equivalent to 5 mg/day) is an effective treatment for mild to moderate papulopustular rosacea and is well tolerated.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cheilitis; Dermatologic Agents; Female; Humans; Isotretinoin; Male; Middle Aged; Retrospective Studies; Rosacea; Young Adult

Isotretinoin remains an effective treatment for severe acne. Despite its effectiveness, it includes many side effects, of which cheilitis is the most common.. To develop an objective grading scale for assessment of isotretinoin-associated cheilitis.. Cross-sectional clinical grading study.. UC Davis Dermatology clinic.. Subjects were older than 18 years old and actively treated with oral isotretinoin.. Oral Isotretinoin.. We developed an Isotretinoin Cheilitis Grading Scale (ICGS) incorporating the following four characteristics: erythema, scale/crust, fissures and inflammation of the commissures. Three board-certified dermatologists independently graded photographs of the subjects.. The Kendall's coefficient of concordance (KCC) for the ICGS was 0.88 (p < 0.0001). The Kendall's coefficient was ≥0.72 (p < 0.0001) for each of the four characteristics included in the grading scale. An image-based measurement for lip roughness statistically significantly correlated with the lip scale/crusting assessment (r = 0.52, p < 0.05).. The ICGS is reproducible and relatively simple to use. It can be incorporated as an objective tool to aid in the assessment of isotretinoin associated cheilitis.

Topics: Acne Vulgaris; Adolescent; Adult; Cheilitis; Cross-Sectional Studies; Erythema; Female; Humans; Isotretinoin; Male; Treatment Outcome; Young Adult

Isotretinoin has revolutionized the management of acne vulgaris. However, concerns continue regarding the adverse effect profile of isotretinoin. This study aims to review the adverse effects experienced by patients started on isotretinoin by a single dermatologist.. Retrospective chart review of 1743 patients started on isotretinoin for various dermatological conditions over a 6-year period. Details of the dose of isotretinoin used, concomitant medications, adverse effects and outcome were recorded.. One-fifth (18.5%) of patients reported no adverse effects during the study period. Cheilitis was the most commonly reported adverse effect, affecting 78% of users, followed by eczema and tiredness, seen in 12% each. However, these were clearly dose-dependent, as the group treated with doses of isotretinoin under 0.25 mg/kg/day only reported cheilitis in 47%, eczema in 7% and tiredness in 5%, compared with 96%, 16% and 18%, respectively, in those treated with more than 0.75 mg/gm/day. Twenty-four patients (1.4%) stopped isotretinoin because of adverse effects; a further three patients complained of severe adverse effects on at least one occasion, but continued taking the medication. The adverse effect(s) that led to patients stopping isotretinoin were cheilitis (22 patients), mood change (13), tiredness (12), eczema (6) and pregnancy (2). There were no reported instances of suicidal ideation or attempted suicide.. Other than the two oral contraceptive failures, there were no serious adverse events recorded during this review period. Isotretinoin is a very effective medication with a low adverse-effect profile when used at lower doses.

Topics: Acne Vulgaris; Adolescent; Adult; Aged; Aged, 80 and over; Cheilitis; Child; Dermatologic Agents; Dose-Response Relationship, Drug; Eczema; Fatigue; Female; Humans; Isotretinoin; Male; Middle Aged; Mood Disorders; Pregnancy, Unplanned; Retrospective Studies; Young Adult

The Childrens Cancer Study Group evaluated daily oral 13-cis-retinoic acid to determine its therapeutic efficacy in 28 children with advanced neuroblastoma refractory to conventional therapy. Cheilitis and fissured lips were the most common side effects; however, fewer than 50% of the patients experienced any toxicity. Two of twenty-two evaluable children demonstrated positive response to therapy. In one case, a child received the drug for 11 months. Seventeen patients demonstrated progressive disease within 28 days of the start of treatment. Three other patients with stable disease, or removed from study at day 28, were considered nonresponsive. Our data demonstrate that, when given as a single daily oral dose of 100 mg/m2, 13-cis-retinoic acid does not have significant activity in children with advanced neuroblastoma.

Topics: Adolescent; Cheilitis; Child; Child, Preschool; Combined Modality Therapy; Humans; Infant; Isotretinoin; Neuroblastoma; Remission Induction; Survival Rate

The effectiveness and tolerance of isotretinoin have been assessed in 72 cases (34 male and 38 female) suffering from papulo-pustular acne with nodulo-cystic component recalcitrant to traditional treatments. The drug confirmed its noteworthy effectiveness and speed of action in all cases. Stress is laid in particular on the lack of recurrence even after a very long-term follow-up. Tolerance was also very good with a prevalent incidence of mucocutaneous signs (desquamation, cheilitis, dermatitis) and the consequent acceptability of treatment on the part of patients.

Topics: Acne Vulgaris; Adolescent; Adult; Cheilitis; Child; Drug Eruptions; Drug Evaluation; Female; Follow-Up Studies; Humans; Isotretinoin; Male

13 patients of both sexes, affected by a severe form of papular rosacea, were treated with 13-cis retinoic acid (1 mg/kg/day) for 2 months. One patient interrupted the treatment after 15 days because of severe blepharitis. The size and number of papules were progressively reduced from the 2nd week, reaching complete regression at the 6th week. Three patients complained of mild blepharitis, 9 patients developed dry cheilitis.

Topics: Adult; Aged; Blepharitis; Cheilitis; Drug Eruptions; Drug Evaluation; Female; Humans; Isotretinoin; Male; Middle Aged; Rosacea; Tretinoin; Triglycerides

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

A new synthetic oral retinoid, 13-cis retinoic acid, is fairly well tolerated in patients and appears to be effective in those with Darier's disease and lamellar ichthyosis. It is less effective in those with pityriasis rubra pilaris. The mechanism of action of 13-cis retinoic acid in disorders of keratinization is unknown at the present time; however, it does not appear to cause lysosomal proliferation in therapeutic doses.

Topics: Adolescent; Adult; Cheilitis; Child; Conjunctivitis; Darier Disease; Dose-Response Relationship, Drug; Evaluation Studies as Topic; Female; Humans; Ichthyosis; Isotretinoin; Male; Middle Aged; Pityriasis Rubra Pilaris; Tretinoin