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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01139749
Other study ID # seb2010
Secondary ID
Status Recruiting
Phase Phase 4
First received June 1, 2010
Last updated October 9, 2011
Start date October 2011
Est. completion date December 2012

Study information

Verified date October 2011
Source Federal University of São Paulo
Contact Edileia Bagatin, PhD
Phone 55-11-55497525
Email edileia_bagatin@yahoo.com.br
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
oral isotretinoin
capsules of 20 mg a day, every other day, for six months
salicylic acid and ciclopirox olamine
Topical salicylic acid and ciclopirox olamine shampoo for scalp and face cleansing, every other day, for six months

Locations

Country Name City State
Brazil Federal University of Sao Paulo - Dermatology Department - Cosmetic Dermatology Unit Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sebum secretion rate Sebum secretion measure on forhead, along scalp line, using Sebumeter,Courage & Khazaka, Köln, Germany. day 0 No
Primary sebum secretion rate Sebum secretion measure on forhead, along scalp line, using Sebumeter, Courage & Khazaka, Köln, Germany day 180 No
Secondary Oral isotretinoin side effects Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile day 0 Yes
Secondary oral isotretinoin side effects Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile day 30 Yes
Secondary oral isotretinoin side effects Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile day 180 Yes
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