Taylor Susan C, Cook-Bolden Fran E, McMichael Amy, Downie Jeanine B, Rodriguez David A, Alexis Andrew F, Callender Valerie D, Alvandi Nancy
J Drugs Dermatol. 2018 Feb 1;17(2):160-167.
Acne vulgaris (acne) is prevalent in individuals with skin of color, often with more frequent sequelae than in patients with lighter skin color. It is important to determine if there are also differences in response to medications.
This study evaluated the efficacy and tolerability of once-daily dapsone gel, 7.5% in patients with acne, stratified by Fitzpatrick skin phototype.
Data were pooled from 2 identically designed, phase 3, randomized, double-blind, vehicle-controlled studies in patients aged 12 years and older with moderate acne. Patients applied dapsone gel, 7.5% or vehicle once daily for 12 weeks. Efficacy was evaluated using the Global Acne Assessment Score (GAAS), lesion counts, and Acne Symptom and Impact Scale (ASIS); adverse events (AEs) and tolerability were also assessed.
This analysis included 2216 patients with skin phototypes I-III and 2111 with types IV-VI. Dapsone gel, 7.5% significantly improved acne severity versus vehicle in both skin phototype subgroups, as determined by the percentage of patients with at least a 1-grade improvement in GAAS and mean change from baseline in GAAS (both, P less than .0001) at week 12 versus baseline. Dapsone gel, 7.5% significantly reduced inflammatory, comedonal, and total lesions in skin phototypes I-III (P less than .001) and IV-VI (P less than equal to .01) versus vehicle. Improvements in inflammatory lesions occurred first, with generally similar patterns of improvement seen over time in GAAS, comedonal lesions, and ASIS domains. The incidence of AEs was similar in both skin phototype subgroups and between study medications. Local scaling, erythema, stinging/burning, and dryness were rated "none" by most patients in both treatment groups and skin phototype subgroups.
Once-daily dapsone gel, 7.5% was effective, safe, and well tolerated in patients with all skin phototypes who were treated for moderate acne. J Drugs Dermatol. 2018;17(2):160-167.
寻常痤疮在有色人种个体中很常见，其后遗症往往比肤色较浅的患者更频繁。确定药物反应是否也存在差异很重要。
本研究评估了每日一次使用7.5%氨苯砜凝胶治疗痤疮患者的疗效和耐受性，并根据 Fitzpatrick 皮肤光类型进行分层。
数据来自两项设计相同的3期随机双盲赋形剂对照研究，研究对象为12岁及以上的中度痤疮患者。患者每天一次涂抹7.5%氨苯砜凝胶或赋形剂，持续12周。使用全球痤疮评估评分（GAAS）、皮损计数和痤疮症状及影响量表（ASIS）评估疗效；同时评估不良事件（AE）和耐受性。
该分析纳入了2216例皮肤光类型为I - III的患者和2111例皮肤光类型为IV - VI的患者。与赋形剂相比，7.5%氨苯砜凝胶在两个皮肤光类型亚组中均显著改善了痤疮严重程度，这通过GAAS至少改善1级的患者百分比以及第12周时GAAS相对于基线的平均变化来确定（两者，P均小于0.0001）。与赋形剂相比，7.5%氨苯砜凝胶显著减少了皮肤光类型I - III（P小于等于0.001）和IV - VI（P小于等于0.01）中的炎性、粉刺性和总皮损。炎性皮损首先出现改善，随着时间推移，GAAS、粉刺性皮损和ASIS各领域的改善模式总体相似。两个皮肤光类型亚组以及研究药物之间的AE发生率相似。在两个治疗组和皮肤光类型亚组中，大多数患者对局部脱屑、红斑、刺痛/烧灼感和干燥的评分为“无”。
对于所有皮肤光类型的中度痤疮患者，每日一次使用7.5%氨苯砜凝胶有效、安全且耐受性良好。《药物皮肤病学杂志》。2018年；17(2):160 - 167。
