Photoaging Clinical Trial
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
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.
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.
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