Tretinoin microsphere gel 0.1% for photodamaged facial skin: a placebo-controlled trial.
Tretinoin microsphere gel (TMG) 0. 1% was evaluated as a treatment of photodamaged skin. The study included a 6-month, randomized, double-blinded, placebo-controlled phase and an additional 6-month open-label phase during which all subjects received TMG 0. 1%. Forty-five subjects with moderate to severe photodamaged facial skin applied study gel topically to the face once nightly (22 subjects received TMG 0.1% and 23 subjects received placebo). At 6 months, TMG 0. 1% was found to be superior to placebo in improving overall severity of photodamage (P=.0003) and in the investigator's global assessment of clinical response (P<.0001). Statistically significant improvement relative to placebo was observed in fine wrinkling (P<.0001), mottled hyperpigmentation (P=.0002), yellowing/ sallowness (P<.0001), and lentigines (P=.0054). The improvements observed after 6 months of open-label therapy were consistent with the results observed in TMG 0. 1%-treated subjects during double-blinded treatment. Most signs and symptoms of cutaneous irritation were mild throughout the treatment period. At one month, a higher proportion of subjects in the TMG 0. 1% group relative to the placebo group experienced an increase in severity of cutaneous irritation. After 6 months, the difference between treatment groups was statistically significant only for peeling (P=.001) and dryness (P=.007).
Weiss
Jonathan S
JS
Gwinnett Clinical Research Center, Inc, 2383 Pate St, Snellville, GA 30078-3233, USA. jsweissgd@bellsouth.net
Shavin
Joel S
JS
Nighland
Marge
M
Grossman
Rachel
R
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007641:Keratolytic Agents / Q000627:therapeutic use*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D015595:Skin Aging / Q000187:drug effects*; D012871:Skin Diseases / Q000188:drug therapy*; D016896:Treatment Outcome; D014212:Tretinoin / Q000627:therapeutic use*; D014466:Ultraviolet Rays / Q000009:adverse effects*
D007641:Keratolytic Agents; D014212:Tretinoin