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Results of Large Phase IV Study Show Differin(R) (adapalene gel) Gel, 0.1% Works Well in Combination With Systemic or Other Topical Agents

- Patients Consider Differin as Part of an Acne Regimen Superior to Previous Acne Treatments -

(Press release from Galderma)

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SAN FRANCISCO, March 3 -- Findings from the M.O.R.E. (Measuring Outcomes in A Real World Experience) Trial presented today at the 64th annual meeting of the American Academy of Dermatology (AAD) show that Differin(R) Gel 0.1% is a topical retinoid preparation that, when combined with other acne products, dramatically improves the efficacy of an acne regimen.

The M.O.R.E. Trial was conducted by over 400 dermatologists from across the U.S. to investigate the efficacy of Differin(R) Gel 0.1% as add-on therapy or first-line combination therapy in moderate-to-moderately severe acne. The study also evaluated patient satisfaction and tolerability with Differin(R) Gel 0.1% as part of an acne regimen.

"What's significant about the M.O.R.E. Trial is that many different treatment strategies are represented; therefore the trial is representative of the real world. Differin(R) Gel 0.1%, when combined with many different products, yielded reliable improvements with excellent tolerability and patient satisfaction and can be regarded as an ideal topical retinoid preparation," said John E. Wolf, Jr. MD, Professor and Chairman at Baylor College of Medicine's department of Dermatology and a member of the steering committee for the trial.

Overall, results showed an 86% satisfaction rate among patients treated with Differin(R) Gel 0.1% as part of an acne regimen(1). A dramatic reduction in comedones and inflammatory lesions (65%) was seen during the 12-week treatment with Differin(R) Gel 0.1%, and Differin(R) Gel 0.1% was very well tolerated by the participants, with less than 6% of subjects reporting any adverse events. The majority of patients (64%) also found Differin(R) Gel 0.1% to be superior to other acne treatments when used in combination therapy.

"The effects of acne can be physically and emotionally scarring and can negatively impact a patient's quality of life. Often, prescribing treatment is challenging because of the differences in efficacy and tolerability among treatments. The M.O.R.E. data provides valuable insights for future approaches to acne treatment," said Dr. Wolf.

Study Design
The M.O.R.E. Trial is a large multi-center, community-based observational phase 4 trial undertaken to better understand the various treatment strategies and their efficacies in the treatment of acne patients. Approximately 1,979 acne patients were recruited for a period of 12 weeks while receiving the treatment recommended by their individual dermatologists. All treatment regimens contained Differin(R) Gel 0.1% in combination with other treatments either first-or second-line. More than 400 dermatologists participated in the study. Patients were assessed at baseline, week 6 and week 12. Numerous subgroup analyses have been performed.

How Differin(R) Gel 0.1% Works
Differin(R) Gel 0.1% is a clear gel that is odorless, oil-free and alcohol-free. Differin(R) Gel 0.1% is applied directly to the face or affected area and is thought to work deep inside the pores to control the cause of the buildup that leads to the formation of acne. Differin(R) Gel 0.1% normalizes the improper accumulation of skin cells that plug the pores and effectively keeps them clear. Pores then begin to function normally again. Differin(R) Gel 0.1% not only helps to prevent the formation of new acne lesions, but also helps the lesions that are already present.

Differin(R) Gel 0.1% is available by prescription only.

During the first few weeks of treatment, itching, dryness, redness, burning or peeling may occur. Exposure to sunlight, including sunlamps, should be minimized during the use of Differin(R) Gel 0.1%. Use of sunscreen and protective clothing over treated areas is recommended when exposure cannot be avoided. As with other acne medications, overexposure to extreme wind or cold, or use of irritating skin care products may aggravate the skin.

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 is a joint venture between Nestle and L'Oreal. 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 www.galdermaUSA.com

Reference:
(1) Data on file, Galderma 2006.
Contacts:
Brian Foard
Denise Scalzo
brian.foard@galderma.com
denise.scalzo@eurorscg.com
214-542-9272
917-667-8791

SOURCE Galderma
Web Site: www.galdermaUSA.com


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