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Clinical Study Shows The Combination Therapy Benzamycin Out-Performs 0.025% Tretinoin/4% Erythromycin In The Treatment Of Facial Acne

Results highlighted in the Journal of Cutaneous Medicine and Surgery

LONDON, ON -- October 23, 2002 -- A new study published online in the Journal of Cutaneous Medicine and Surgery shows that the combination, topical therapy 3% erythromycin/5% benzoyl peroxide, commonly known as Benzamycin®, may provide a greater beneficial effect than 0.025% tretinoin/4% erythromycin in the treatment of moderate facial acne. A summary of this study can be accessed by logging onto http://link.springer-ny.com/link/service/journals/10227/index.htm.

"Our findings demonstrate that the combination found in Benzamycin® is more effective than Stievamycin® in the treatment of facial acne," said Aditya K. Gupta, M.D., Ph.D., F.R.C.P.C., Associate Professor, Division of Dermatology, Department of Medicine, Sunnybrook and Women's College Health Sciences Center and the University of Toronto, and lead author of the study.

Resistance to antibiotic agents is increasing in P. acnes strains. Combination treatments have been investigated to combat this problem. Medications with different mechanisms of action may exhibit a synergistic response against the bacteria, producing greater effect than a single agent alone, such as Benzamycin, a combination of erythromycin (antibiotic) and benzoyl peroxide (anti-microbial). Clinical studies have shown that Benzamycin can produce improvements in mild to moderate acne in as little as two weeks when compared to either medication used alone.

The multicenter, randomized, double-blind, parallel group study compared the effectiveness of 3% erythromycin/5% benzoyl peroxide and 0.025% tretinoin/4% erythromycin in patients with moderate facial acne. The study was comprised of 112 subjects between the ages of 14 and 30. Medication was applied twice daily to all facial acne lesions with one of the two topical gels, for the treatment period of 12 weeks. At each visit, a count of papules, pustules and comedones was recorded.

At the end of the treatment period, both physicians and patients were surveyed to determine the final outcome. The survey included three components: physician-related
symptoms (number of lesions of all types), physician-related severity and patient-related severity. Mann-Whitney U calculations were used to compare the aggregate scores between the two treatment regimens. In conclusion, it was determined that Benzamycin (3% erythromycin/5% benzoyl peroxide) reduced the severity of symptoms at a faster rate than 0.025% tretinoin/4% erythromycin, and produced significantly less erythema.

"The combination of these benefits may help lead to increased compliance, which is a major factor in successfully treating patients, especially teenagers, who tend to feel self-conscious about their appearance when it is affected by acne," said Dr. Gupta.

Benzamycin is indicated in the treatment of moderate acne vulgaris characterized by comedones, inflammatory papules/pustules, with or without an occasional cyst or nodule. Its safety and effectiveness in children less than 12 years have not been established. Most common adverse effects are local irritation reactions such as irritation of the skin including: peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, irritation of the eyes, skin discoloration, oiliness, tenderness of the skin, pruritus and edema.

About Acne

Acne is a common skin disease affecting young Canadians, which has the potential to severely affect both their physical and mental health. According to the Canadian Dermatology Association, the damaged caused by acne can be avoided by early and effective treatment. Acne usually develops in adolescence, and most people (approximately 85%) will outgrow it by the time they reach their mid-twenties.

About Dermik Laboratories

Dermik Laboratories, Inc. conducts the global dermatology business of Aventis Pharmaceuticals, the prescription drug business of Aventis. Dermik Laboratories is dedicated to providing innovative dermatological products to satisfy the needs of health care providers and patients. Dermik focuses on treatments for a wide range of skin and nail problems, including acne, fungal infections, pre-cancerous lesions, psoriasis and rosacea. Its corporate headquarters is located in Berwyn, Pa. Please visit us at our website: www.dermik.com.

About Aventis
Aventis Pharmaceuticals conducts the U.S. prescription drug business of Aventis. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.

Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of € 17.7 billion ($15.9 billion), invested approx. € 3 billion ($2.7 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.

Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.



SOURCE: Dermik Laboratories, Aventis Pharmaceuticals

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