Draelos Zoe Diana, Rodriguez David A, Kempers Steven E, Bruce Suzanne, Peredo Marina I, Downie Jeanine, Chang-Lin Joan-En, Berk David R, Ruan Shiling, Kaoukhov Alexandre
J Drugs Dermatol. 2017 Jun 1;16(6):591-598.
BACKGROUND: Acne vulgaris has varying physical and psychological effects in men and women of different ages, races, and ethnicities.
OBJECTIVE: This analysis assessed the relationship of age, sex, and race to treatment response with once-daily topical dapsone gel, 7.5%.
METHODS: We conducted a pooled subgroup analysis of 2 randomized, double-blind, vehicle-controlled clinical trials conducted in the US and Canada. The studies included patients with 20 to 50 inflammatory and 30 to 100 noninflammatory facial lesions, and a Global Acne Assessment Score (GAAS) of 3 (moderate). Pooled data (N=4340) were analyzed by age (12-17 and ≥18 years), sex, and race (Caucasian and non-Caucasian) for GAAS success (score of 0 [none] or 1 [minimal]) and mean percent change from baseline in inflammatory, noninflammatory, and total lesion counts. The impact of age and sex on treatment response was examined using multivariate analysis. Adverse events were analyzed by subgroups.
RESULTS: Treatment responses with dapsone gel, 7.5% were greater overall and for all subgroups versus vehicle. GAAS success rates and mean decrease in all lesion counts with dapsone gel, 7.5% were greater in older (aged ≥18 years) versus younger patients, and for females versus males. Treatment response with dapsone gel, 7.5% in racial subgroups was similar. Multivariate analysis showed statistical significance for age group and sex as predictors of GAAS success (P less than equal to .005) and reduction in lesion counts (P less than equal to .025). Adverse events were similar across subgroups.
CONCLUSIONS: Older age (≥18 years) and female sex were predictors of treatment response. These subgroups tended to have greater acne improvement in subgroup comparisons. Caucasian and non-Caucasian patients had similar responses. The safety profile of dapsone gel, 7.5% was similar across subgroups.
J Drugs Dermatol. 2017;16(6):591-598.
.背景：寻常痤疮对不同年龄、种族和民族的男性和女性有不同的生理和心理影响。 目的：本分析评估了年龄、性别和种族与每日一次外用7.5%氨苯砜凝胶治疗反应之间的关系。 方法：我们对在美国和加拿大进行的2项随机、双盲、赋形剂对照临床试验进行了汇总亚组分析。这些研究纳入了有20至50个炎性面部皮损和30至100个非炎性面部皮损且全球痤疮评估评分（GAAS）为3（中度）的患者。对汇总数据（N = 4340）按年龄（12至17岁和≥18岁）、性别和种族（白种人和非白种人）分析GAAS成功情况（评分为0[无]或1[轻微]）以及炎性、非炎性和总皮损计数相对于基线的平均变化百分比。使用多变量分析检查年龄和性别对治疗反应的影响。对不良事件进行亚组分析。 结果：总体而言，7.5%氨苯砜凝胶的治疗反应在所有亚组中均优于赋形剂。7.5%氨苯砜凝胶的GAAS成功率和所有皮损计数的平均减少率在年龄较大（≥18岁）的患者中高于较年轻患者，在女性中高于男性。7.5%氨苯砜凝胶在不同种族亚组中的治疗反应相似。多变量分析显示年龄组和性别作为GAAS成功（P≤0.005）和皮损计数减少（P≤0.025）的预测因素具有统计学意义。各亚组的不良事件相似。 结论：年龄较大（≥18岁）和女性是治疗反应的预测因素。在亚组比较中，这些亚组的痤疮改善往往更大。白种人和非白种人患者的反应相似。7.5%氨苯砜凝胶的安全性在各亚组中相似。 《皮肤药物学杂志》2017年；16(6):591 - 598。
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