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Topical Tazarotene Shows Efficacy and Tolerability for Acne Vulgaris: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 13, 2004 -- Data from a meta-analysis of head-to-head Phase 4 studies indicate that tazarotene 0.1% gel or cream formulation is efficacious for treatment of acne vulgaris regardless of skin type, race or gender, researchers reported here on February 7^th at the 62^nd American Academy of Dermatology Annual Meeting.

"This meta-analysis of Phase 4 trials adds to that information with regard to race gender and skin type," said lead investigator James Leyden, MD, Professor Emeritus of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, United States. "It will help doctors and patients refine their choices."

The data on 471 subjects came from 6 multicentre, double blind, randomised, head-to-head studies. The investigators performed this retrospective meta-analysis to determine whether gender, skin type and disease severity influence efficacy and tolerability of treatment.

Of the 385 using the gel formulation, 41.8% were male; 71.2% were Caucasian, 18.4% were black, 4.4% Asian, 3.1% Hispanic and 2.1% were "other race" 23.6% had oily skin 37.9% had normal/oily skin, 12.5% normal skin, 6.8% normal/dry, 1.8% dry and 16.1% oily/dry.

Of the 86 subjects using the cream formulation, 41.9% were male; 67.4% were Caucasian, 20.9% were black, 4.7% Asian, 4.7% Hispanic and 2.3% "other race"; 18.6% had oily skin type, 36.1% normal/oily skin, 8.1% normal skin, 11.6% normal dry skin, 2.3% dry skin and 23.3% mixed oily/dry skin.

For all of the studies, subjects were told to wash their face with non-medicated, non-soap cleanser and to apply 15 minutes later a pea-sized amount of the study agent, covering the entire face with a thin film. They were allowed to use a non-comedogenic moisturizer as needed.

The investigators found that, among all subjects using either cream or gel once daily for 12 weeks, global improvement averaged 50% to 75%. At end point in all trials, subjects in both groups rated their treatment as either "favourable" or "highly favourable."

The researchers found that topical tazarotene in either formulation was effective and well tolerated in a wide variety of subjects, regardless of disease severity, skin type, gender, racial origin or time of year that treatment began. They also found that the topical formulations were effective not only for mild and moderate acne but also for moderate-to-severe-acne.

Both cream and gel were very well tolerated. Mean levels of erythema, dryness, burning, peeling and pruritus remained less than mild throughout treatment.

The authors reported that in subjects with dry skin, tazarotene treatment helped normalise dryness, and in subjects with oily or mixed oily/dry skin it helped normalise the perception of oiliness. "In general, tolerability can be optimised by using tazarotene gel," They noted. "However, in females with inflammatory acne whose top priority is efficacy, tazarotene gel may be preferred."

Tazarotene 0.1% cream is approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of acne vulgaris. Tazarotene gel 0.1% is FDA-approved for the topical treatment of mild-to-moderate facial acne vulgaris.


[Study title: Topical Tazarotene Meta-Analysis in Acne Vulgaris. Poster 93]

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