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Title: Tazarotene More Efficacious than Tretinoin for Photodamaged Skin: Presented at AAD

"Tazarotene More Efficacious than Tretinoin for Photodamaged Skin: Presented at AAD"

By Bruce Sylvester WASHINGTON, DC -- February 10, 2004 -- Tazarotene 0.1% cream (Avage™) is more efficacious than tretinoin 0.05% emollient cream (Renova®) for the treatment of photodamaged skin, particularly regarding speed of improvement, researchers reported here February 8th at the American Academy of Dermatology 62nd Annual Meeting. "We noted the speed of improvement in visual appearance of tazarotene subjects relative to tretinoin subjects," said Emil Tanghetti, MD, clinical professor of dermatology, University of California Davis Medical Center, Sacramento, California. "For hyperpigmentation in particular, tazarotene cream works quickly, and the results appear to [improve] with time. Of course, it is to be used with normal skin care and sunlight avoidance." Investigators randomised 88 patients to tazarotene and 85 to tretinoin emollient. Of those, 157 finished the 24-week multicentre, double blind, randomised and parallel-group study. The subjects were predominantly Caucasian women with a mean age of 55 years, presenting moderate fine wrinkling and mottled hyperpigmentation. Both cohorts showed comparable symptoms at baseline. Subjects applied treatment in the evening, once daily for 24 weeks. They were instructed to dry their faces and remove makeup before each application. The subjects were asked to use a "pea-sized' amount of medication to cover the face, allowing enough time for the medication to dry before bedtime. Subjects were permitted to use moisturizers, as long as the skin was allowed to dry between the application of moisturizer and study agent. The investigators instructed the subjects to apply sunscreen of sun protection factor (SPF) 15 or greater at least once daily in the morning, to avoid excessive sun exposure and to wear protective clothing (hat or visor) when in direct sunlight. The primary study end point was 50% or greater global improvement in the global response scales. Secondary efficacy variables included overall measure of the following: photodamage, fine wrinkling, mottled hyperpigmentation, irregular depigmentation, lentigines, coarse wrinkling, elastosis, tactile roughness, telangiectasia, actinic kurtosis and appearance of pore size. The investigators reported that 78% of the tazarotene cream group reached 50% or greater global improvement at end point, compared to 67% in the tretinoin emollient group, with statistical significance in favour of tazarotene emerging by week 16. The authors wrote, "All other significant between-group differences in efficacy measures were also in favour of tazarotene -- for the overall integrated assessment of photo damage at week 16, fine wrinkling at week 24, mottled hyperpigmentation at weeks 12 and 16, and coarse wrinkling at week 4." "The findings are quite significant," added Dr. Tanghetti, "because our patients want quicker and better results. We see that vividly in this comparative study." Tazarotene 0.1% cream is approved in the United States as adjunctive therapy for the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who follow comprehensive skin-care and sunlight-avoidance regimens. This study was supported by Allergan, Inc. [Study title: Tazarotene 0.1% Cream Versus Tretinoin 0.005% Emollient Cream in the Treatment of Photodamaged Facial Skin: A Multicenter, Double-Blind, Randomized, Parallel-Group Study. Abstract 11]

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