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Tazarotene Cream Superior to Tretinoin in Treating Photodamaged Skin: Presented at AAD

By Paula Moyer

SAN FRANCISCO, CA -- March 25, 2003 -- Tazarotene cream has advantages over tretinoin in treating photodamaged facial skin, according to Nicholas J. Lowe, MD.

"Interim data show that tazarotene is significantly superior to tretinoin emollient in mean global responses, overall assessment of photodamage, and fine wrinkling," stated Dr. Lowe, clinical professor of dermatology, University of California-Los Angeles, here at the 61^st Annual Meeting of the American Academy of Dermatology. "Patients on tazarotene had more rapid improvements than those on tretinoin."

This multi-centre, double-blind, randomised, parallel-group study sought to compare the efficacy and tolerability of tazarotene 0.1% cream to that of tretinoin 0.05% emollient cream in patients with photodamaged facial skin.

The investigators recruited 173 adult patients with skin type I – IV. To be eligible, patients had to have at least mild levels of fine wrinkling and mottled hyperpigmentation, or at least moderate levels of one of these types of sun damage. The study's exclusion criteria ruled out patients who had undergone a facial cosmetic or therapeutic procedure in the previous four months, as well as patients who were planning to undergo such a procedure during the study.

Before treatment began, the participants had to forego oral vitamin A or E supplements, more than 5,000 IU/day and more than 400 IU/day, respectively, for 7 days. The other washout periods were as follows: 14 days for topical therapies other than retinoids; 30 days for topical retinoids, as well as for antibiotic and investigational drugs; 180 days for oral retinoids.

The participants were randomised to receive treatment with either tazarotene 0.1% cream or tretinoin 0.05% emollient cream. They applied the treatments to their faces once every evening for 24 weeks. According to study instructions, patients applied a pea-sized amount of the medication, so that the entire face was lightly covered. They were to remove all cosmetics from their faces, and to wash and dry the face so that the treatment was applied to a dry surface.

The study instructions directed patients to allow enough time for the study medication to dry before they went to bed. The subjects were permitted to use a moisturiser if the medication dried between the application of the moisturizer and the study medication.

The researchers determined clinical efficacy measures by overall assessment, defining success as a more than 50% global improvement. They also assessed fine wrinkling, mottled hyperpigmentation, lentigenes, and tactile roughness, and graded these features on a 0 to 4 severity scale; 0 indicated none and 4 was severe.

The data showed significantly more global improvement in the tazarotene group than in the tretinoin group (p<0.01). The tazarotene group also had significantly more improvement regarding fine wrinkling, hyperpigmentation, and lentigenes (p<0.05), but there were no significant differences between the two groups' improvements in tactile roughness.

Tolerability was equivalent in both groups, with no significant differences regarding several issues that have been reported in tretinoin treatment. Subjects in both groups had similar rates of irritation, retinoid dermatitis, peeling, redness, burning, dryness, acne, scaling, and itching. Dr. Lowe pointed out that these discomforts can be minimised in the clinical setting if patients start treatment with alternate-day applications, and if they use a non-soap cleanser.

The study was funded through an unrestricted educational grant provided by Allergan Skin Care, Irvine, CA.

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