NCT00842907

Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

A Clinical, Laboratorial and Quality of Life Study to Evaluate the Efficacy and Safety of Oral Isotretinoin in the Treatment of Cutaneous Photodamage

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Photodamage
• Photoaging

Interventions

Type	Name	Description
DRUG	oral isotretinoin	one 20.0 mg capsule, once a day, every other day, during 24 weeks
DRUG	Tretinoin	0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-12-01
• Completion: 2010-08-01
• First posted: 2009-02-12
• Last updated: 2010-06-08

Locations

1 site across 1 country: Brazil