TY - JOUR
T1 - Efficacy of 0.1% Tazarotene cream for the treatment of photodamage
T2 - A 12-month multicenter, randomized trial
AU - Phillips, Tania J.
AU - Gottlieb, Alice B.
AU - Leyden, James J.
AU - Lowe, Nicholas J.
AU - Lew-Kaya, Deborah A.
AU - Sefton, John
AU - Walker, Patricia S.
AU - Gibson, John R.
AU - Buntin, Denise M.
AU - Fisher, George Burch
AU - Coleman, William P.
AU - Funicella, Toni
AU - Heffernan, Michael P.
AU - Levine, Norman
AU - Loss, Robert W.
AU - Silvis, Nancy G.
AU - Swinyer, Leonard J.
AU - Tashjian, David N.
AU - Washenik, Kenneth J.
AU - Welch, Kevin L.
AU - Wilson, David C.
PY - 2002/11/1
Y1 - 2002/11/1
N2 - Objective: To determine the efficacy and safety of 0.1% tazarotene cream for the treatment of photodamage. Design: A 24-week multicenter, double-blind, randomized, vehicle-controlled intervention study followed by a 28-week open-label extension. Setting: Ambulatory patients in private and institutional practice. Patients: 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. Intervention: 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. Main Outcome Measures: 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 (≥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.
AB - Objective: To determine the efficacy and safety of 0.1% tazarotene cream for the treatment of photodamage. Design: A 24-week multicenter, double-blind, randomized, vehicle-controlled intervention study followed by a 28-week open-label extension. Setting: Ambulatory patients in private and institutional practice. Patients: 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. Intervention: 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. Main Outcome Measures: 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 (≥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.
UR - http://www.scopus.com/inward/record.url?scp=0036846916&partnerID=8YFLogxK
M3 - Article
C2 - 12437455
AN - SCOPUS:0036846916
SN - 0003-987X
VL - 138
SP - 1486
EP - 1493
JO - Archives of Dermatology
JF - Archives of Dermatology
IS - 11
ER -