Tretinoin cream 0.02% for the treatment of photodamaged facial skin: a review of 2 double-blind clinical studies.
In extensive clinical studies and practical use since its US Food and Drug Administration approval in 1995, tretinoin emollient cream 0.05% has been shown to be safe and effective in the treatment of fine facial wrinkles, mottled hyperpigmentation, and skin roughness. To provide additional prescribing flexibility for various patient needs, a new lower concentration formulation, tretinoin cream 0.02% was chosen for further development. Two multicenter, randomized, double-blind, vehicle-controlled clinical., studies were conducted to evaluate the safety and efficacy of the lower concentration tretinoin formulation in the treatment of moderate-to-severe facial photodamage. Results indicate statistically significant improvement in fine wrinkling, coarse wrinkling, and yellowing with the use of tretinoin cream 0.02% at week-24 end point, compared with placebo. Therapy with tretinoin cream 0.02% was well tolerated overall and demonstrated a favorable safety profile. Both studies demonstrated that tretinoin cream 0.02% is safe and effective for the treatment of moderate-to-severe photodamaged facial skin.
Nyirady
J
J
Johnson & Johnson Consumer Products Worldwide, Skillman, New Jersey 08558-9418, USA.
Bergfeld
W
W
Ellis
C
C
Levine
N
N
Savin
R
R
Shavin
J
J
Voorhees
J J
JJ
Weiss
J
J
Grossman
R
R
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004643:Emollients / Q000008:administration & dosage; D004954:Esthetics; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D012720:Severity of Illness Index; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage*
D004643:Emollients; D014212:Tretinoin