Safety and Efficacy Evaluation of Tretinoin Cream 0.02% for the Reduction of Photodamage: A Pilot Study
January 2012 | Volume 11 | Issue 1 | Original Article | 83 | Copyright © January 2012
Leon H. Kircik MD
Mount Sinai Medical Center, New York, NY Indiana University School of Medicine, Indianapolis, IN
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.
INTRODUCTION
Dermatoheliosis, better known as photodamage or photoaging, is a condition that results from prolonged
or repeated sun exposure or other ultraviolet radiation sources and leads to characteristic changes in skin structure, function, and appearance.1-3 Features observed on photodamaged skin include fine and coarse wrinkles, roughness,
laxity, sallowness, mottled hyperpigmentation, and telangiectasia.
Histologic changes in photodamaged skin also reveal atypical epidermal cells, skin thinning and atrophy, elastosis, increased melanogenesis, excessive deposition of glycosaminoglycans, and decreased collagen.
Although overall thinning of the dermis is linked to chronological
aging of the skin and other intrinsic factors such as hormonal status and comorbid diseases, extrinsic influences like photodamage due to ultraviolet radiation and cigarette smoking account for the majority of age-associated cosmetic skin problems.
3-7 Sex, geographic location, and skin phototype and color also play a role in photodamage. Similar to skin cancer induction,
the risk of photodamage is generally higher in fairer and less pigmented skin (Fitzpatrick skin types I, II, and III).8,9
In most societies in which the aging population is growing and a high value is placed on the maintenance of a youthful appearance,
personal concerns can lead to difficulties with interpersonal relations, ability to work, and self-esteem10; hence, there is a growing desire for interventions that improve the visible signs of aging. In addition to preventive sunscreens, some topical compounds
(antioxidants, topical retinoids, natural polysaccharides, topical α and β hydroxyacids) and surgical procedures (dermabrasion,
laser resurfacing, chemical peeling) have been shown to improve age-related skin damage.3
