Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea
NCT ID: NCT01139749
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2011-10-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oral isotretinoin
Subjects from treatment arm will be treated with low-dose oral isotretinoin - 20 mg a day, every other day, for six months
oral isotretinoin
capsules of 20 mg a day, every other day, for six months
salicylic acid and ciclopirox olamine
Subjects from comparison arm will be treated with topical salicylic acid and ciclopirox olamine shampoo
salicylic acid and ciclopirox olamine
Topical salicylic acid and ciclopirox olamine shampoo for scalp and face cleansing, every other day, for six months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* pregnancy risk
* diabetes
* collagen diseases
* bone or muscles diseases
* alcohol abuse
* hypervitaminosis A
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of São Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Edileia Bagatin
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edileia Bagatin, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Federal University of Sao Paulo - Dermatology Department - Cosmetic Dermatology Unit
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
seb2010
Identifier Type: -
Identifier Source: org_study_id