Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea
Clinical, Laboratorial and Quality of Life Trial to Evaluate the Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 12, 2011
October 1, 2011
9 months
June 1, 2010
October 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sebum secretion rate
Sebum secretion measure on forhead, along scalp line, using Sebumeter,Courage \& Khazaka, Köln, Germany.
day 0
sebum secretion rate
Sebum secretion measure on forhead, along scalp line, using Sebumeter, Courage \& Khazaka, Köln, Germany
day 180
Secondary Outcomes (3)
Oral isotretinoin side effects
day 0
oral isotretinoin side effects
day 30
oral isotretinoin side effects
day 180
Study Arms (2)
Oral isotretinoin
ACTIVE COMPARATORSubjects from treatment arm will be treated with low-dose oral isotretinoin - 20 mg a day, every other day, for six months
salicylic acid and ciclopirox olamine
ACTIVE COMPARATORSubjects from comparison arm will be treated with topical salicylic acid and ciclopirox olamine shampoo
Interventions
capsules of 20 mg a day, every other day, for six months
Topical salicylic acid and ciclopirox olamine shampoo for scalp and face cleansing, every other day, for six months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- difficulty to follow study conditions
- pregnancy risk
- diabetes
- collagen diseases
- bone or muscles diseases
- alcohol abuse
- hypervitaminosis A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Sao Paulo - Dermatology Department - Cosmetic Dermatology Unit
São Paulo, São Paulo, 04022-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edileia Bagatin, PhD
Federal University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 1, 2010
First Posted
June 9, 2010
Study Start
October 1, 2011
Primary Completion
July 1, 2012
Study Completion
December 1, 2012
Last Updated
October 12, 2011
Record last verified: 2011-10