Del Rosso James Q, Kircik Leon, Gallagher Conor J
Touro University College of Osteopathic Medicine, Henderson, Nevada; Las Vegas Skin and Cancer Clinics/West Dermatology Group, Henderson, Nevada;
Mount Sinai Medical Center, New York, New York; Indiana University School of Medicine, Indianapolis, Indiana; Physicians Skin Care PLLC, Louisville, Kentucky;
J Clin Aesthet Dermatol. 2015 Jan;8(1):31-7.
To determine whether the response to dapsone 5% gel was similar in adolescent girls and adult women with facial acne vulgaris.
Subgroup analysis of female subjects with acne vulgaris receiving active treatment enrolled in two randomized, double-blind Phase 3 clinical trials.
Twice-daily applications of dapsone 5% gel over 12 weeks.
Adolescent (12-17 years of age) and adult (≥18 years of age) females.
At baseline and at Weeks 2,4,6,8, and 12, subjects were evaluated using the global acne assessment score and by counts of inflammatory, noninflammatory, and total acne vulgaris lesions. Adverse events were monitored.
A total of 347 adolescent and 434 adult women were included in the subgroup analysis. At Week 12, dapsone 5% gel significantly reduced mean global acne assessment score in both subgroups (p<0.001); however, the proportion of subjects with clinical success (no or minimal acne based on global acne assessment score) at Week 12 was greater in adult women (53.5%) versus adolescent females (45.3%, p=0.022). Significantly greater percentage reductions in both noninflammatory (p<0.0001) and total lesion counts (p=0.0008) were observed in the adult group as compared to the adolescent group. Percentage reductions from baseline in inflammatory lesions were similar in both groups. No major safety issues and no previously unrecognized safety signals were noted.
This subgroup analysis of female patients indicates that dapsone 5% gel twice daily is effective in reducing inflammatory and noninflammatory acne vulgaris lesions in both adolescent and adult women, and is safe in these subgroups. Overall, these data suggest that efficacy of dapsone 5% gel twice daily for facial acne vulgaris may be greater in the adult female population.
确定5%氨苯砜凝胶治疗寻常型面部痤疮时，青春期女孩与成年女性的反应是否相似。
对两项随机、双盲3期临床试验中接受积极治疗的寻常型痤疮女性受试者进行亚组分析。
12周内每日两次外用5%氨苯砜凝胶。
青春期（12 - 17岁）和成年（≥18岁）女性。
在基线以及第2、4、6、8和12周时，使用整体痤疮评估评分以及炎性、非炎性和寻常型痤疮总皮损计数对受试者进行评估。监测不良事件。
亚组分析共纳入347名青春期女性和434名成年女性。在第12周时，5%氨苯砜凝胶使两个亚组的平均整体痤疮评估评分均显著降低（p<0.001）；然而，第12周时临床取得成功（根据整体痤疮评估评分痤疮无或极少）的受试者比例在成年女性中（53.5%）高于青春期女性（45.3%，p = 0.022）。与青春期组相比，成年组非炎性皮损计数（p<0.0001）和总皮损计数（p = 0.0008）的百分比降低幅度显著更大。两组炎性皮损从基线开始的百分比降低幅度相似。未发现重大安全问题以及此前未识别的安全信号。
该女性患者亚组分析表明，每日两次外用5%氨苯砜凝胶对青春期和成年女性的炎性和非炎性寻常型痤疮皮损均有效，且在这些亚组中是安全的。总体而言，这些数据表明每日两次外用5%氨苯砜凝胶治疗寻常型面部痤疮在成年女性人群中疗效可能更佳。
