Galderma announces positive results for severe acne treatment

Galderma, a Fort Worth-based company focused on medical solutions for skin health, announced May 7 the publication of results from the Phase 4 ALAMO study, which evaluated the effectiveness and safety of Epiduo® Forte in patients with severe inflammatory acne (non-nodulocystic/non-conglobate) during a 12-week treatment period.

“Severe inflammatory acne is notoriously difficult to treat. These real-world study results are encouraging and provide positive efficacy results with the combination treatment of Epiduo Forte Gel plus oral doxycycline 200 mg,” said Linda Stein Gold, M.D., ALAMO investigator, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and paid Galderma consultant, in a company-issued news release.

Acne is the most common skin condition in the United States, affecting up to 50 million Americans annually, and approximately 85 percent of teenagers and young adults. Severe acne can be difficult to treat, the company said in a news release.

“Not only can acne be associated with embarrassment, anxiety and depression, it also has the potential to leave permanent physical scars. The risk of acne scarring increases with delays in treatment,” the company said.

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The study results were published in the Journal of Drugs in Dermatology.

After 12 weeks of treatment, 90.2 percent of study participants reported moderate (28.8 percent; severity scale: 2), marked (44.2 percent; severity scale: 1) or complete (17.2 percent; severity scale: 0) improvement in their acne using the Assessment of Acne Improvement, an efficacy-related subject-reported survey that uses a scale of 0 to 5 (with 0 indicating complete improvement and 5 indicating worse).

No serious or severe adverse events (AEs) were reported, and most AEs were mild in intensity, the company said. The most common treatment-emergent AEs were skin burning sensation and erythema (redness), reported by 3.4 and 2.9 percent of study participants, respectively.

The ALAMO study evaluated the efficacy and safety of Epiduo Forte Gel plus oral doxycycline 200 mg (50-mg tablets, two tablets twice daily) given over 12 weeks to treat severe, inflammatory acne. A total of 23 U.S. sites enrolled 186 patients; 185 patients received a baseline assessment, and 175 patients received at least one dose of the study drug (97 females and 78 males).

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Galderma said results showed a large reduction in lesion count with Epiduo Forte Gel plus doxycycline in the study participants, with a 66.2 percent reduction in inflammatory lesions, a 58.7 percent reduction in non-inflammatory lesions and a 62.6 percent reduction in total lesions at week 12 compared to baseline.

Additionally, 37.1 percent of study participants were clear or almost clear of acne as measured by the Investigator’s Global Assessment (IGA) success rate. At 12 weeks, 80.1 percent of study participants were no longer considered by their investigator to be candidates for oral isotretinoin, a prescription treatment for severe acne, the company said in the release.

“While many treatment options are available for mild to moderate acne, there are few effective, convenient and safe treatment options for the first-line treatment of severe acne as recommended by the American Academy of Dermatology,” said Chris Chapman, vice president and general manager of Galderma’s U.S. prescription business. “We are pleased with the positive ALAMO clinical findings, which demonstrate how individuals with difficult-to-treat, severe acne respond to and benefit from Epiduo Forte Gel in combination with oral doxycycline,” Chapman said. “These real-world data underscore our commitment to providing healthcare providers and patients with innovative treatment options for acne.”

The company said acne is It is caused by a combination of oil and dead skin cells, which clog pores, allowing the bacteria associated with acne to grow. Approximately 40 percent of people with acne have scars.

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Not only can acne leave physical scars, it can also leave psychological and emotional scars including negative impacts on self-image and psychological well-being, anxiety, depression, lower self-esteem and negative emotions, the company said/

Galderma, NestlĂ© Skin Health’s medical solutions business, was created in 1981 and is now present in more than 100 countries with an extensive product portfolio to treat a range of dermatological conditions.

galderma.com

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