Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage
Recruitment status was Active, not recruiting
This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical, histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment of photodamage on face and forearms. Main oral isotretinoin safety parameters will also be analyzed, as well as adverse events related to topical products.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Clinical, Laboratorial and Quality of Life Study to Evaluate the Efficacy and Safety of Oral Isotretinoin in the Treatment of Cutaneous Photodamage|
- Clinical, histological and immunohistochemical features before and after treatments [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||August 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: oral isotretinoin
Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks.
Drug: oral isotretinoin
one 20.0 mg capsule, once a day, every other day, during 24 weeks
Other Name: oral retinoid
Active Comparator: tretinoin
Twelve patients will be treated with 0,05% tretinoin cream applied on face and forearms at night and moisturizer broad-spectrum sunscreen twice a day.
0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks
A 24-week study, with 7 or 9 monthly visits, comprising healthy adult volunteers, aged 50 to 75 years will be carried out. The patients should present advanced to severe photodamage on face and forearms. Written informed consent will be obtained from each subject prior to enrollment.
Eligible patients will be randomly divided in two groups:
A- 10 patients will be treated with oral isotretinoin, 20.0 mg/day, every other day, 15 capsules per month, for 24 weeks, associated with the use of moisturizer broad spectrum sunscreen twice a day.
B- 10 patients (controls) will be treated with 0,05% tretinoin cream applied on face and forearms at night and the same moisturizer broad-spectrum sunscreen twice a day.
After randomization, laboratory tests will be requested for patients from group A and will be repeated on weeks 4 and 24.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842907
|Federal University of Sao Paulo|
|Sao Paulo, SP, Brazil, 04022000|
|Principal Investigator:||Edileia Bagatin, MD, PhD||Federal University of Sao Paulo, Brazil|