Healthcare Industry News:  Galderma Laboratories 

Biopharmaceuticals Dermatology

 News Release - March 6, 2006

Study Compares Once-daily Metronidazole 1% Gel to Twice-daily Azelaic Acid 15% Gel in the Treatment of Rosacea

More Patients Report Moderate to Severe Stinging and Burning with Azelaic Acid 15% Gel than with Metronidazole 1% Gel as Their Worst Score (P=.002)(1)

SAN FRANCISCO, March 6 (HSMN NewsFeed) -- Findings from a phase IIIB study comparing the efficacy and safety of once-daily metronidazole 1% gel (MetroGel® 1%) to twice-daily azelaic acid 15% gel (Finacea(TM)) in the treatment of rosacea, presented at the 64th annual meeting of the American Academy of Dermatology (AAD), demonstrate statistically similar efficacy, safety, and tolerability between the two treatment options.(2) In the study, once-daily use of metronidazole 1% gel and twice-daily use of azelaic acid 15% gel resulted in similar reductions in erythema, lesions, and investigator global severity scores. The results of this 15-week study are expected to provide valuable information to dermatologists choosing a treatment regimen for their rosacea patients.

"This study showed that once-daily treatment with metronidazole 1% is just as efficacious as twice-daily treatment with azelaic acid 15% gel," said John E. Wolf, Jr. MD, Professor and Chairman at Baylor College of Medicine's department of Dermatology and lead investigator on the study. "The most marked difference in tolerability that was observed was in stinging and burning, which was statistically worse for the patients treated with azelaic acid 15% gel twice daily compared to metronidazole 1% gel once daily after three weeks of treatment."

More patients in the study reported being "not bothered at all" by metronidazole 1% gel side effects (74% vs. 53%, P=.009) and wanted to use it again compared to responses of patients having used azelaic acid 15% gel (84.4% vs. 79.7%). Although not statistically significant, more patients were satisfied with the cosmetic properties of metronidazole 1% gel (35.1%) than with azelaic acid 15% gel (25.7%). Recently, a 1% concentration of metronidazole was made available in a cosmetically appealing gel formulation. The previous available formula contained a .75% concentration. The new vehicle is 92% water-based and contains niacinamide (vitamin B3), beta cyclodextin, and a low concentration of propylene glycol. These hydrosolubilizing agents have been shown to hydrate the skin.(3)

A patient-satisfaction questionnaire given at the end of the study also demonstrated an improvement in quality of life for patients enrolled in the study, with 70% of all patients feeling better from their treatment.

Study Design

This phase III study was a randomized, multi-center, investigator-blind, active-controlled, parallel comparison study that enrolled 160 patients among 15 sites. Male or female subjects, at least 18 years of age with moderate rosacea were eligible for enrollment in the study. An investigator's global severity score of 3 on a 0-4 scale was required along with confirmation of at least 8-50 inflammatory lesions on the face and a maximum of 2 nodules. Disease severity was graded on a 5-point scale where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe. Pregnant and breast feeding females were not allowed to participate.

The average age of all patients was 51 years (range 31-78). Approximately 73% of all patients were female and 86% of patients were Caucasian. Patients were randomized to treatment with either once-daily metronidazole gel or twice-daily azelaic acid per product use instructions. Subjects were evaluated at baseline and at three week intervals for the duration of the 15-week study. Evaluations included lesion counts, erythema severity, and investigator's global severity.

About MetroGel® 1%

MetroGel® (metronidazole) Topical Gel 1% is a topical treatment for the inflammatory lesions of rosacea. MetroGel® 1% incorporates a higher concentration of metronidazole and a reduced dosage of once-daily versus twice-daily use (as compared to the previously available MetroGel® .75%). The new, technologically advanced vehicle incorporates HSA-3, a combination of niacinamide, betadex, and propylene glycol. The vehicle is a water-based formulation and contains no alcohol. MetroGel® 1% is available by prescription only and is currently the #1 prescribed topical treatment option for rosacea.(4)

About Rosacea

Rosacea is a common, chronic facial skin disease characterized by the presence of facial erythema, visible blood vessels, and papules and pustules. It has been estimated to affect more than 14 million people in the United States, with about 60% of cases being adults under the age of 50. The cause of rosacea is still in question, and presently, a cure does not exist. Many of the available systemic and topical treatments for rosacea are effective, but require long-term continuous use.(5) With the face being the predominant site of involvement, this disease is often associated with serious psychosocial morbidity and can significantly impact quality of life.

About Galderma

Galderma is one of the world's leading pharmaceutical companies, focusing exclusively on research, development, and marketing of dermatological products. Its expertise spans a broad spectrum of skin, hair, and nail diseases.

Created in 1981, Galderma today employs 2,300 people and is headed worldwide by president & CEO Humberto C. Antunes. The parent company, Galderma Pharma, is headquartered in Lausanne, Switzerland. Galderma Laboratories, L.P. is the North American subsidiary.

For more information on Galderma, visit

The following adverse experiences have been reported with the topical treatment of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities, and nausea.

(1) Wolf, John E. Efficacy and Safety of Once-Daily Metronidazole 1% Gel Compared to Twice-Daily Azelaic Acid 15% Gel in the Treatment of Rosacea (Poster #562). Presented at the 64th Annual Meeting of the American Academy of Dermatology, March 3-6, 2006.

(2) In press. Cutis. More detailed information regarding this study will appear in an upcoming Cutis supplement.

(3) Dow G, Chang Y, Yang M, Yu K, Basu S. A Novel Aqueous Metronidazole Gel 1% with Hydro-solubilizing Agents. Poster presentation at the ACADEMY '05 meeting of the American Academy of Dermatology, July 20-24, 2005.

(4) PHast Database, "Metro Market - Weekly TRx Count," as of 2/10/2006.

(5) Nybaek H, Jemec GB. Photodynamic therapy in the treatment of rosacea. Dermatology. 2005;211(2):135-138.

Source: Galderma

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