July/August 2015
Volume 13 • Issue 4
Industry update Jo-Ann Kalaka-Adams, Section Editor
Galderma Product Line Expands as Promised by President Todd Zavodnick Jo-Ann Kalaka-Adams
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alderma Laboratories, L.P., has won FDA approval for Epiduo® Forte Gel, its new antibiotic-free treatment for acne, and for Restylane® Lyft (formerly Perlane®)-L) with Lidocaine to lift the cheeks and improve smile lines. Earlier this year, the company launched Benzac® Acne Solutions, its first OTC product to treat acne. Epiduo® Forte Gel markedly improves severe acne Galderma’s Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%, is a once-daily, topical treatment for moderate to severe acne vulgaris. The FDA approval was based on a 12-week, multicenter, randomized, double-blinded study of 217 patients. The results showed superiority of Epiduo® Forte Gel over vehicle gel at week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory and non-inflammatory lesion count. Subjects with “severe” acne (50%) at baseline were required to become “clear” or “almost clear” within the trial period to be considered a treatment success. Marked improvement in severe acne was observed in 50.5% of subjects treated with Epiduo® Forte Gel. According to dermatologist and principal investigator Jonathan Weiss, MD, patients using Epiduo® Forte Gel saw improvement at week 1 with efficacy continuing to improve through week 12. The product was shown to be safe and well tolerated, and most adverse events were mild to moderate in severity. The most commonly reported adverse events (≥1%) in patients treated with Epiduo® Forte Gel were skin irritation, eczema, atopic dermatitis, and a skin burning sensation. The antibiotic-free product can be considered for long-term use and offers convenience in a pump with once-daily dosing. Epiduo® Forte Gel becomes available by prescription in September 2015. Restylane® Lyft corrects volume loss in mid-face area The injectable Restylane® Lyft with Lidocaine is the first FDAapproved filler to provide fullness to the cheeks and to correct and smooth the nasolabial folds (smile lines) in patients over the SKINmed. 2015;13:335
age of 21. “Achieving natural-looking lift in the cheek area is one of my most frequent requests,” says dermatologist and principal investigator Robert Weiss, MD. “The results show that Restylane® Lyft can provide an effective option for patients who desire lift—not just volume— in their cheeks.” In Dr. Weiss’s 200-patient study, 88.7% of patients treated with Restylane® Lyft showed improvement in fullness in the right and left midface areas (combined) at 2 months, and more than half of patients maintained improvement for 12 months. The most common adverse events were tenderness, redness, bruising, swelling and itching, all of which decreased in severity over time and most were resolved within 2 weeks. Restylane® Lyft with Lidocaine is available only through a physician. Complete instructions for use are at www.RestylaneUSA.com. Benzac® Acne Solutions available without prescription Early this year, Galderma launched its first OTC regimen for the treatment of stubborn acne and prevention of new breakouts. In a clinical study, 91% of patients saw improvement in their acne in two weeks when using the new 3-step Benzac® Acne Solutions, which includes the Benzac® Skin Balancing Foaming Cleanser, Benzac® Intensive Spot Treatment and Benzac® Blemish Clearing Hydrator. According to dermatologist Jeanine Downie, MD, Benzac® is the only skincare line to use East Indian Sandalwood Oil, a key ingredient known to have antibacterial and anti-inflammatory properties and to sooth the skin. In addition to salicylic acid, Benzac® also contains Kakadu plum, an antioxidant super fruit known for having the highest natural concentration of vitamin C to brighten the skin; lemon myrtle, a natural astringent to help reduce excess oil; and zinc to prevent loss of skin moisture. Safe for sensitive skin, Benzac® is dermatologist-tested, non-comedogenic, and free of artificial fragrances and dyes. The Benzac® Complete Acne Solutions Regimen is available at major retailers, Benzac.com, and Amazon.com.
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