Quality of Life Clinical Trial
Official title:
Clinical, Laboratorial and Quality of Life Trial to Evaluate the Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea.
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.
Oral isotretinoin is a retinoid that controls gene expression related to cellular
proliferation, differentiation, with specific action over sebocytes, reducting sebaceous
gland size and secretion rate. Its binding to specific retinoid nuclear receptors is weak.
It is the gold standard drug to treat moderate to severe acne. Other indications have been
suggested: seborrhea, seborrheic dermatitis, rosacea and non-melanoma skin cancer
prevention. There are well known reversible side effects like the mucocutaneous - cheilitis,
dryness of skin, nose and eyes and risk of alterations in lipid profile and transaminases.
The major problem is teratogenicity which demands pregnancy control by two different
methods, from treatment beginning to one month after treatment end.
Seborrhea and seborrheic dermatitis are chronic and correlated conditions characterized by
oily skin, hair and scalp, erythema, desquamation and negative impact on quality of life.
Seborrhea is a very common problem, affecting 30% of population. Seborrheic dermatitis
affects 3 to 5% of world population, with no differences for gender and race. The
etiopathogenic factors involved in these conditions are: individual susceptibility, elevated
sebaceous secretion and irritant action of products from lipophilic yeasts of Malassezia
gender. The treatment usually involves topical use of corticosteroids, salicylic acid,
ketoconazole, ciclopirox olamine, pimecrolimus and tacrolimus. The dermatosis impact on
quality of life has been more and more evaluated by generic and specific questionnaires. The
most used generic questionnaires are:"Dermatology Life Quality Index or DLQI" and "Medical
Outcomes Study 36-Item Short-Form Health Survey or SF-36". Recently a specific questionnaire
for oily skin named "Oily Skin Self-Image Questionnaire or OSSIQ" was published. 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 (20 mg a day, every other day) will be compared to
topical anti-seborrheic products to evaluate the reduction of sebaceous secretion and
colonization of affected areas by saprophyte yeasts of Malassezia gender. Efficacy will be
evaluated by clinical parameters, as well as by sebum measure and application of two quality
of life questionnaires: SF-36 and OSSIQ (after translation and validation for Brazilian
Portuguese). Safety will be evaluated by skin hydration measure, side effects report and
observation. The devices Sebumeter and Corneometer, from Courage & Khazaka, Köln, Germain,
will be used. For subjects using oral isotretinoin blood counting, transaminases, lipid
profile and pregnancy test will be requested as selection criteria, on days 30 and 180.
Results will be submitted to statistical analysis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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