Study Shows Azelaic Acid 15% Gel (Finacea(TM)) is Safe And Effective for Treating Moderate Rosacea

HERSHEY, Pa., March 24 /PRNewswire/ -- A new topical gel may offer hope to the 14 million Americans with rosacea, a chronic skin condition marked by periods of facial flushing, redness, lesions and pustules.

Results from two identical, multi-center trials reported by principal investigator, Diane Thiboutot, M.D., associate professor of dermatology at Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, showed that azelaic acid 15% gel (AzA gel) significantly reduced redness and the number of inflammatory lesions (bumps and pimples) in patients with moderate papulopustular facial rosacea. Thiboutot presented the results March 22 at the 61st Annual Meeting of the American Academy of Dermatology in San Francisco.

"The results showed that AzA gel is promising as a new therapy for patients with this type of moderate rosacea," Thiboutot said. "Currently there are some patients whose rosacea doesn't respond well to available therapies. The approval of AzA gel offers an additional alternative for these patients."

Rosacea most often affects fair-skinned adults in their 30s, although people with varying skin types may also have rosacea. Because it is found primarily on the face, rosacea can often have devastating psychological and social effects on sufferers who become anxious or embarrassed about their appearance. The causes of rosacea are unknown.

In the two studies combined, 664 patients with moderate rosacea from 27 medical centers in the United States were randomized into two treatment groups. One group received a water-based gel that did not contain a medication (placebo), and the other group received the same gel but containing 15 percent AzA, a naturally occurring substance already approved for the treatment of acne. The studies were double blind, meaning that neither the patients nor the physicians knew which patients were using active gel and which were using the placebo. Patients applied the gel to the affected areas on the face two times a day for 12 weeks.

Both the investigators and the patients reported their feelings about the tolerability and effectiveness of the treatment. Physicians rated the patients' improvements by using the investigators global assessment (IGA) of rosacea severity, a numerical ranking assigned based on redness and the number and types of bumps and lesions. Physicians and patients also rated overall improvement, and patients reported how they felt about the use and comfort of the study medication.

Results from the two parallel studies were reported separately. Physicians noted a reduction in mean inflammatory lesion count of 58 percent and 51 percent with AzA gel compared to only 40 percent and 39 percent with the placebo in Study 1 and Study 2, respectively. Erythema decreased in severity in 44 percent and 46 percent of patients treated with AzA gel and 29 percent and 28 percent with the placebo in Study 1 and Study 2, respectively. The IGA scores showed that, post-treatment, 61 percent and 62 percent of patients who were treated with AzA gel achieved success, defined as a clear, minimal or mild rating on the IGA rosacea scale. Only 40 percent and 48 percent achieved such improvement with the placebo in Study 1 and Study 2, respectively.

The study did show that the treatment had no effect on a rosacea symptom called telangiectasia, which is a type of lesion caused by dilation, or enlargement, of tiny blood vessels.

Overall, investigators reported that significantly more patients in the AzA gel group improved than in the placebo group. In the two studies, 61 percent and 58 percent of patients gave AzA gel a "good" or "excellent" rating compared to only 43 percent and 34 percent from patients who were on placebo (Study 1 and 2, respectively).

"Not only was the AzA gel effective, patients reported that it was comfortable to use and, only in a few cases, caused minor skin irritation," Thiboutot said. Patients rated "cosmetic acceptability," or the general comfort and use, of the both the active and inactive gels as "very good," "good," or "satisfactory."

The study was sponsored by Berlex Laboratories of New Jersey. This product, being commercialized under the name Finacea(TM), has been approved by the Food and Drug Administration and was launched by Berlex Laboratories, Inc., at the same American Academy of Dermatology meeting.

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