Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01139749

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Seborrhea Seborrheic Dermatitis Quality of Life	Drug: oral isotretinoin Drug: salicylic acid and ciclopirox olamine	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical, Laboratorial and Quality of Life Trial to Evaluate the Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea.

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral isotretinoin Subjects from treatment arm will be treated with low-dose oral isotretinoin - 20 mg a day, every other day, for six months	Drug: oral isotretinoin capsules of 20 mg a day, every other day, for six months Other Names: low-dose oral isotretinoin off label use of oral isotretinoin
Active Comparator: salicylic acid and ciclopirox olamine Subjects from comparison arm will be treated with topical salicylic acid and ciclopirox olamine shampoo	Drug: salicylic acid and ciclopirox olamine Topical salicylic acid and ciclopirox olamine shampoo for scalp and face cleansing, every other day, for six months Other Names: anti-seborrheic treatment anti-dandruff treatment

Arm

Intervention/Treatment

Active Comparator: Oral isotretinoin

Subjects from treatment arm will be treated with low-dose oral isotretinoin - 20 mg a day, every other day, for six months

Drug: oral isotretinoin

capsules of 20 mg a day, every other day, for six months

Other Names:

low-dose oral isotretinoin

off label use of oral isotretinoin

Active Comparator: salicylic acid and ciclopirox olamine

Subjects from comparison arm will be treated with topical salicylic acid and ciclopirox olamine shampoo

Drug: salicylic acid and ciclopirox olamine

Topical salicylic acid and ciclopirox olamine shampoo for scalp and face cleansing, every other day, for six months

Other Names:

anti-seborrheic treatment

anti-dandruff treatment

Outcome Measures

Primary Outcome Measures

Sebum secretion rate [day 0]
Sebum secretion measure on forhead, along scalp line, using Sebumeter,Courage & Khazaka, Köln, Germany.
sebum secretion rate [day 180]
Sebum secretion measure on forhead, along scalp line, using Sebumeter, Courage & Khazaka, Köln, Germany

Secondary Outcome Measures

Oral isotretinoin side effects [day 0]
Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile
oral isotretinoin side effects [day 30]
Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile
oral isotretinoin side effects [day 180]
Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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