Efficacy of 0.1% tazarotene cream for the treatment of photodamage: a 12-month multicenter, randomized trial.
OBJECTIVE
To determine the efficacy and safety of 0.1% tazarotene cream for the treatment of photodamage.


METHODS
A 24-week multicenter, double-blind, randomized, vehicle-controlled intervention study followed by a 28-week open-label extension.


METHODS
Ambulatory patients in private and institutional practice.


METHODS
Of 563 patients with facial photodamage, 91% and 86% completed the double-blind and open-label phases, respectively. In the double-blind phase, 20 of 283 tazarotene-treated patients and 1 of 280 vehicle-treated patients discontinued treatment owing to adverse events.


METHODS
Once-daily application of 0.1% tazarotene cream or nonmedicated vehicle cream to the face for 24 weeks. Then, all continuing patients received treatment with 0.1% tazarotene cream for another 28 weeks.


METHODS
Primarily, fine wrinkling and mottled hyperpigmentation. Also, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, coarse wrinkling, telangiectasia, actinic keratoses, overall integrated assessment of photodamage, global response to treatment, patients' overall assessment of photodamage, and plasma levels of tazarotenic acid.


RESULTS
Compared with the vehicle, at week 24 tazarotene resulted in a significantly greater incidence of patients achieving treatment success (>or=50% global improvement) and at least a 1-grade improvement in fine wrinkling, mottled hyperpigmentation, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, coarse wrinkling, and the overall integrated assessment of photodamage (P<.01). Additional clinical improvement occurred with continued tazarotene treatment and had not plateaued by week 52. Plasma tazarotenic acid concentrations did not exceed 0.71 ng/mL.


CONCLUSIONS
Once-daily applications of 0.1% tazarotene cream significantly reduced multiple signs of photodamage. Plasma levels of tazarotenic acid remained below those of endogenous retinoids.
Phillips
Tania J
TJ
Boston University School of Medicine, Boston, MA 02118, USA. tphill@BU.edu
Gottlieb
Alice B
AB
Leyden
James J
JJ
Lowe
Nicholas J
NJ
Lew-Kaya
Deborah A
DA
Sefton
John
J
Walker
Patricia S
PS
Gibson
John R
JR
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009539:Nicotinic Acids / Q000008:administration & dosage*; D009824:Ointments; D012016:Reference Values; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome; D012176:Retinoids
D003879:Dermatologic Agents; D009539:Nicotinic Acids; D009824:Ointments; C086827:tazarotene; D012176:Retinoids