JDDonline.com

January 2012

83

VOLUME 11 • ISSUE 1

Safety and Efficacy Evaluation of Tretinoin Cream 0.02% for the Reduction of Photodamage: A Pilot Study

Abstract

Background: Clinical studies as well as histologic data maintain that tretinoin improves the appearance of photodamage; however, the long-term benefits of tretinoin 0.02% in moderate to severe photodamage have not been established.
Objective: We performed independent assessments to demonstrate the long-term safety and efficacy of tretinoin emollient cream 0.02% for moderate to severe facial photodamage.
Methods: A single-center, open-label, single-group observational study followed 19 patients over 52 weeks. Efficacy assessments consisted of the Glogau Photodamage Classification Scale and severity grading of photodamage signs and symptoms. Facial photography and biopsies were taken from three subjects at baseline and final visits. Tolerability was assessed by the investigator.
Results: Twelve patients completed 52 weeks of treatment. Mean change in Glogau photodamage demonstrated statistically significant differences at 3, 6, 9, and 12 months (P<.0005). All patients with moderate to severe photodamage had improved to mild photodamage status by 9 months. Statistically significant improvements (P<.05) were observed at all time points for fine wrinkling, tactile roughness, and mottled hyperpigmentation as well as for lentigines at 6, 9, and 12 months and telangiectasia at 12 months. Biopsy samples revealed microscopic improvement in photodamage. Tretinoin cream 0.02% was generally well-tolerated, with few subjects experiencing adverse events.
Limitations: Our pilot study is limited by lack of control and the small study sample.
Conclusions: Tretinoin cream 0.02% was safe and effective for moderate to severe photodamage of facial skin and demonstrated sustainable benefits over an entire year based on the clinically validated Glogau classification system and expert visual grading analysis.

J Drugs Dermatol. 2012;11(1):83-90.

View HTML version   Download PDF One Time Purchase

In proceeding with payment you agree to purchase a one-time PDF download of the selected JDDonline content. The PDF is only available for single computer on-screen use; printing, duplicating, or reproducing this content is strictly prohibited per the Copyright Protection Act.