阿达帕林/过氧化苯甲酰凝胶0.3%/2.5%：适用于所有皮肤光类型的安全有效痤疮治疗方法。
Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes.
作者信息
Alexis Andrew F, Cook-Bolden Fran E, York J P
出版信息
J Drugs Dermatol. 2017 Jun 1;16(6):574-581.
BACKGROUND: Acne affects individuals of all races and ethnicities; however, lighter and darker skin phototypes face different treatment challenges that may affect treatment response and tolerability. This analysis investigated possible differences in the efficacy and safety of the fixed dose combination of 0.3% adapalene with 2.5% benzoyl peroxide (A/BPO gel 0.3%/2.5%) in subjects with Fitzpatrick Skin Types (FST) I-VI.
METHODS: This was a post-hoc analysis of a Phase 3, multicenter, randomized, double-blind, parallel-group study of moderate to severe acne in subjects with FST I-VI. Subjects received A/BPO gel 0.3%/2.5%, A/BPO gel 0.1%/2.5% (benchmark), or vehicle, once daily for 12 weeks. Efficacy measurements included success rate (IGA of Clear or Almost Clear), change in inflammatory and noninflammatory lesions from baseline to week 12, safety, and tolerability. The intent to treat (ITT) and safety populations were analyzed. Demographics and disposition were analyzed with descriptive statistics; categorical variables by frequency and percentage; and continuous variables with means, medians, minimum, maximum, and standard deviations.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 128 subjects with FST I-III, and 89 subjects with FST IV-VI. At week 12, A/BPO gel 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle for all FST and severity groups in inflammatory and noninflammatory lesion reduction (P less than equal to .05). Compared to baseline, 32% of subjects with FST I-III were clear or almost clear, compared to 7% in the vehicle group (P=.001). In FST IV-VI, 28% of subjects were clear or almost clear, compared to 15% for vehicle (P=NS). In all treatment groups and skin phototypes, week 12 tolerability scores were similar to baseline scores, and tolerability scores for most subjects of all skin phototypes were "none" or "mild" for all measures.
SUMMARY: We report that the fixed dose combination of A/BPO gel 0.3%/2.5% is efficacious and safe in patients with FST I-VI with moderate and severe inflammatory acne.
Clinicaltrials.gov registry: NCT01880320
J Drugs Dermatol. 2017;16(6):574-581.
.背景
痤疮影响所有种族和族裔的个体；然而，肤色较浅和较深的皮肤光类型面临不同的治疗挑战，这可能会影响治疗反应和耐受性。本分析调查了0.3%阿达帕林与2.5%过氧化苯甲酰固定剂量组合（0.3%/2.5%A/BPO凝胶）在Fitzpatrick皮肤类型（FST）I - VI受试者中的疗效和安全性可能存在的差异。
方法
这是一项对FST I - VI受试者中重度痤疮的3期、多中心、随机、双盲、平行组研究的事后分析。受试者接受0.3%/2.5%A/BPO凝胶、0.1%/2.5%A/BPO凝胶（对照）或赋形剂，每日一次，持续12周。疗效测量包括成功率（IGA为清除或几乎清除）、从基线到第12周炎症性和非炎症性皮损的变化、安全性和耐受性。对意向性治疗（ITT）和安全性人群进行了分析。人口统计学和处置情况采用描述性统计分析；分类变量采用频率和百分比分析；连续变量采用均值、中位数、最小值、最大值和标准差分析。
结果
0.3%/2.5%A/BPO凝胶治疗组包括128名FST I - III受试者和89名FST IV - VI受试者。在第12周时，0.3%/2.5%A/BPO凝胶对于所有FST和严重程度组在减少炎症性和非炎症性皮损方面是安全、可耐受的，且显著优于赋形剂（P≤0.05）。与基线相比，FST I - III组中32%的受试者清除或几乎清除，而赋形剂组为7%（P = 0.001）。在FST IV - VI组中，28%的受试者清除或几乎清除，赋形剂组为15%（P = 无显著性差异）。在所有治疗组和皮肤光类型中，第12周的耐受性评分与基线评分相似，所有皮肤光类型的大多数受试者在所有测量中的耐受性评分为“无”或“轻度”。
总结
我们报告0.3%/2.5%A/BPO凝胶固定剂量组合在患有中度和重度炎症性痤疮的FST I - VI患者中有效且安全。
Clinicaltrials.gov注册号：NCT01880320
《皮肤药物杂志》。2017年；16(6):574 - 581。
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