Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Oral isotretinoin is the gold standard drug to treat moderate to severe acne. Other indications like seborrhea, seborrheic dermatitis have been suggested. There is risk of reversible mucocutaneous side effects, as well as alterations in lipid profile and transaminases. The major problem is teratogenicity which demands pregnancy control from treatment beginning to one month after treatment end. Seborrhea and seborrheic dermatitis are chronic conditions characterized by oily skin, hair and scalp, erythema, desquamation and negative impact on quality of life. This will be an interventional, therapeutic and quality of life randomized, comparative (parallel groups), blinded evaluation clinical trial, comprising 50 men and women, aged 18 to 40. Treatment with low-dose oral isotretinoin will be compared to topical anti-seborrheic products to evaluate the reduction of sebaceous secretion and colonization of affected areas by yeasts of Malassezia gender. Efficacy will be evaluated by clinical parameters, as well as by sebum secretion measure and application of quality of life questionnaires. Safety will be evaluated by skin hydration measure, side effects report and observation. For subjects using oral isotretinoin blood counting, transaminases, lipid profile and pregnancy test will be requested as selection criteria, on days 30 and 180. Data will be submitted to statistical analysis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Ciclopirox; Isotretinoin; Salicylates; Salicylic Acid

Criteria

Inclusion Criteria:

• consent form signature

• presence of seborrhea and / or seborrheic dermatitis on face and scalp

• good health

• no previous treatment with oral isotretinoin in the last 6 months

• normal laboratorial tests: pregnancy test, blood counting, transaminases and lipide profile

• concordance on use of two anticonceptional methods, during and until one month after the end of the study

Exclusion Criteria:

• difficulty to follow study conditions

• pregnancy risk

• diabetes

• collagen diseases

• bone or muscles diseases

• alcohol abuse

• hypervitaminosis A