Safety and efficacy evaluation of tretinoin cream 0.02% for the reduction of photodamage: a pilot study.
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.


CONCLUSIONS
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.
Mount Sinai Medical Center, New York, NY, USA. dermresearch@wedoderm.com
Leon H
LH
Kircik
D000287:Administration, Topical; D000368:Aged; D004341:Drug Evaluation; D004643:Emollients; D005145:Face / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D015595:Skin Aging / Q000187:drug effects* / Q000473:pathology*; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects*
D004643:Emollients; D014212:Tretinoin