Comparative trial shows adapalene 0.1% gel has more rapid reduction in acne lesions than tretinoin 0.025% gel.

SAN FRANCISCO--(BW HealthWire)--March 21, 1997--

New Generation Retinoid Offers Impressive

Activity for the Treatment of Acne Vulgaris,

Results Seen In One Week

Data that will be presented on March 23 at the American Academy of Dermatology's 55th Annual Meeting indicate that adapalene 0.1% gel (Differin(TM) Gel, Galderma) shows a more rapid reduction in acne lesions than tretinoin 0.025% gel (Retin-A(R), Ortho) in the treatment of acne vulgaris. This multicenter, randomized, investigator-masked, parallel group study demonstrated that adapalene 0.1% gel reduced inflammatory and total lesion counts more rapidly than tretinoin 0.025% gel in patients with mild to moderate acne vulgaris. Adapalene also was better tolerated than tretinoin.

"Adapalene gel gave quicker results than tretinoin gel, with a significant difference being detected between the two products after one week's treatment and also demonstrated less skin irritation," said Alan Clucas, MD, senior medical advisor at CIRD Galderma who will present the data. "This new retinoid molecule represents a distinctive and significant advance in acne therapy."

The 105 patients enrolled were randomized to receive either adapalene gel or tretinoin gel, once daily at bedtime for a period of 12 weeks. Efficacy was determined by evaluating overall lesion counts, non-inflammatory lesion and inflammatory lesion counts and by global assessment of improvement and disease severity.

In terms of efficacy, adapalene gel demonstrated favorable results in one week when compared to tretinoin gel:

- inflammatory lesion counts: 32 percent reduction vs. 17 percent

respectively (p=0.001)

- total lesion count: 30 percent reduction vs. 22 percent

respectively (p=0.042)

- global severity grade: 28 percent reduction vs. 16 percent

respectively (p<0.001)

- clinically significant reduction of inflammatory lesion

counts (>25%): 70 percent vs.35 percent respectively (p<0.05)

No significant differences were detected between the two treatments in terms of percentage change in any of the efficacy variables at week 12.

Galderma Laboratories, a subsidiary of L'Oreal and Nestle, is a leading research-based pharmaceutical company dedicated to developing novel prescription and over-the-counter treatments for dermatological diseases. Devoted exclusively to dermatology, the company is focused on treatments for disease areas including acne, rosacea, psoriasis, eczema, and skin infections. Galderma is an international skin care products company with its U.S. headquarters located in Fort Worth, Texas.

CONTACT: Tom Jones/Deborah Miller

Ketchum Public Relations

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