結果顯示，使用adapalene 0.1%洗劑可顯著降低病灶總數(第一篇研究、治療前比治療後為：51.5% vs 37.1%；第二篇研究、治療前比治療後為：44.6% vs 32.8%)，相較於只有賦形劑，發炎病灶在這兩篇試驗分別是：54.9% vs 40.3%以及 46.0% vs 36.9%，非發炎病灶在這兩篇試驗分別是：49.6% vs 35.7%以及43.1% vs 30.2%。
March 23, 2010 — The US Food and Drug Administration (FDA) has approved the first lotion formulation of adapalene (Differin 0.1%, Galderma Laboratories, LP) for the topical treatment of acne in patients aged 12 years and older. The prescription retinoid product is expected to be available in April 2010.
FDA approval was based on data from two 12-week, multicenter clinical trials of 2141 patients with 20 to 50 inflammatory and 30 to 100 noninflammatory acne lesions at baseline.
Results showed that use of adapalene 0.1% lotion yielded significant reductions from baseline in the mean total number of lesions (study 1, 51.5% vs 37.1%; study 2, 44.6% vs 32.8%), inflammatory lesions (54.9% vs 40.3% and 46.0% vs 36.9%), and noninflammatory lesions (49.6% vs 35.7% and 43.1% vs 30.2%) compared with the vehicle alone.
Dry skin of mild to moderate severity was the most frequently reported adverse event (7%), occurring primarily during the first 2 weeks of treatment and decreasing with continued use. Other treatment-related effects included erythema, scaling, dryness, and stinging/burning.
"The new formulation of well-tolerated [adapalene] provides dermatologists with a once-daily treatment option to help keep acne under control," said Linda Stein Gold, MD, clinical trial investigator and director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit, Michigan, in a company news release. "Because everyone's skin is unique, it is important to have multiple treatment options available in a variety of formulations, allowing dermatologists to take a truly individualized approach to the management of acne."
Adapalene lotion should be applied as a thin film to the entire face and other affected areas of skin once daily after washing with a mild soapless cleanser. A moisturizer may be used if symptoms of local skin irritation occur.
Patients using adapalene lotion should be advised to avoid exposure to sunlight and sunlamps; sunscreen and protective clothing are recommended. Concomitant application of topical products with a strong drying effect should be avoided, particularly if they contain sulfur, resorcinol, or salicylic acid.
Adapalene should not be applied to cuts, abrasions, or eczematous or sunburned skin. As with other retinoids, use of waxing as a depilatory method should be avoided on skin treated with adapalene lotion.
Adapalene previously was available in 0.1% gel, cream, and topical solution formulations, and as a combination gel with benzoyl peroxide.
