FDA核准Adapalene洗劑用於治療青春痘

作者：Yael Waknine  
出處：WebMD醫學新聞

　　March 23, 2010 — 美國食品藥物管理局(FDA)核准第一種adapalene洗劑配方(商品名Differin 0.1%，Galderma Laboratories藥廠)用於治療12歲以上病患的青春痘，這個處方用維甲酸化合物(retinoids)產品預計在2010年4月上市。
　　
　　FDA的此項核准是根據兩個為期12週的多中心臨床試驗資料，共有2,141名病患，開始時分別有20-50個發炎青春痘以及30-100個非發炎青春痘。
　　
　　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%。
　　
　　最常報告的副作用是輕微到嚴重的皮膚乾燥(7%)，主要發生在治療最初的2週，持續使用後則此情形減少，其他治療相關的影響包括紅斑、鱗屑、乾燥以及刺痛/灼熱感。
　　
　　密西根底特律亨利福特醫院皮膚科主任、臨床研究主任、臨床試驗研究者Linda Stein Gold醫師在藥廠新聞稿中表示，耐受良好的adapalene新配方提供皮膚科醫師每天治療一次的選項，有助於控制青春痘病況，因為每個人的膚質都是獨特的，因此，有各種配方提供多種治療選項是重要的，可讓皮膚科醫師儘量以個人化方式治療青春痘。
　　
　　Adapalene洗劑在使用時，以溫和無皂清潔液清洗之後，在整個臉上或其他患部皮膚塗一薄層，如果有局部皮膚刺激感，可以使用潤膚霜。需建議使用adapalene洗劑的病患避免曝露於陽光或日光燈下；建議使用防曬霜與穿著有防護力的衣物。避免同時使用具有強力乾燥效果的局部外用產品，特別是含有硫、樹脂酚(resorcinol)或水楊酸者。
　　
　　應避免將Adapalene用於切割傷、擦傷、濕疹或曬傷的皮膚處，如同其他維甲酸化合物，在使用adapalene洗劑的皮膚處需避免使用石蠟除毛。
　　
　　Adapalene原本有的劑型為0.1% 凝膠、乳劑、外用溶液配方，以及含有過氧化苯(benzoyl peroxide)的複方凝膠。
　　  


FDA Approves Adapalene Lotion to Treat Acne

By Yael Waknine
Medscape Medical News

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.