Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea
Status:
Unknown status
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
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.