Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

A clinical and histological randomized controlled phase II trial to evaluate the efficacy and safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A- 21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three months; B- 11 women received only same moisturizer/sunscreen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Isotretinoin; Terephthalylidene dicamphor sulfonic acid

Criteria

Inclusion Criteria:

• menopausal or sterilized women

Exclusion Criteria:

• woman at risk of pregnancy, with alterations on liver function or lipid profile