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Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00842907
Study type Interventional
Source Federal University of São Paulo
Contact
Status Unknown status
Phase Phase 2
Start date May 2009
Completion date August 2010
View Details
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