Ting William
California Dermatology Care, San Ramon, CA 94583, USA.
Cutis. 2012 Aug;90(2):91-6.
This randomized, observer-blind, split-face study assessed the irritation potential and likelihood of continued use of clindamycin phosphate 1.2%--benzoyl peroxide (BPO) 2.5% gel or adapalene 0.1%--BPO 2.5% gel once daily over a 14-day treatment period in 21 participants (11 males; 10 females) with acne who were 18 years or older. Investigator clinical assessment (erythema and dryness) and self-assessment (dryness and burning/stinging) were performed at baseline and each study visit (days 1-14) using a 4-point scale (O = none; 3 = severe). Transepidermal water loss (TEWL) and corneometry measurements were performed at baseline and days 3, 5, 7, 9, 11, and 14. Lesions were counted at baseline and on day 14. Participant satisfaction questionnaires were completed on days 7 and 14. At the end of the study, investigators reported none or only mild erythema in 86% (18/21) of participants treated with clindamycin phosphate 1.2%--BPO 2.5% gel compared with 62% (13/21) of participants treated with adapalene 0.1%--BPO 2.5% gel. No severe erythema was reported with clindamycin phosphate 1.2%--BPO 2.5% gel. Adapalene 0.1%--BPO 2.5% gel was prematurely discontinued due to severe erythema in 1 participant on day 5 and a second participant on day 9. Additionally, 2 more participants reported severe erythema on day 14. Mean erythema scores were 0.9 (mean change from baseline, 0.7) with clindamycin phosphate 1.2%--BPO 2.5% gel and 1.4 (mean change from baseline, 1.3) with adapalene 0. 1%--BPO 2.5% gel on day 14 (P < .05 for days 6-14). Similar results were seen with dryness. Mean scores were 0.5 (mean change from baseline, 0.4) and 1.0 (mean change from baseline, 1.0), respectively (P < .05 for days 6-14). Self-assessment, TEWL, and corneometry results underscored the investigator clinical assessment. Participant preference and likelihood of continued usage was greater with clindamycin phosphate 1.2%--BPO 2.5% gel. Continued use and efficacy results for the treatment of acne were influenced by the potential of the product to cause irritation and the participant preferences. Irritation potential was more pronounced and severe with adapalene 0.1%--BPO 2.5% gel. Undoubtedly, as a result more participants preferred treatment with clindamycin phosphate 1.2%--BPO 2.5% gel and were more likely to continue to use the product.
这项随机、观察者盲法、半脸对照研究评估了21名18岁及以上痤疮患者（11名男性；10名女性）在14天治疗期内每日一次使用1.2%克林霉素磷酸酯-2.5%过氧化苯甲酰（BPO）凝胶或0.1%阿达帕林-2.5%BPO凝胶的刺激可能性和持续使用的可能性。在基线和每次研究访视（第1 - 14天）时，采用4分制（0 = 无；3 = 严重）进行研究者临床评估（红斑和干燥）和自我评估（干燥和灼烧/刺痛）。在基线以及第3、5、7、9、11和14天进行经表皮水分流失（TEWL）和角质层测量。在基线和第14天对皮损进行计数。在第7天和第14天完成参与者满意度问卷。研究结束时，研究者报告，使用1.2%克林霉素磷酸酯-2.5%BPO凝胶治疗的参与者中，86%（18/21）无红斑或仅有轻度红斑，而使用0.1%阿达帕林-2.5%BPO凝胶治疗的参与者中这一比例为62%（13/21）。使用1.2%克林霉素磷酸酯-2.5%BPO凝胶未报告有严重红斑。0.1%阿达帕林-2.5%BPO凝胶因1名参与者在第5天和另1名参与者在第9天出现严重红斑而提前停药。此外，还有2名参与者在第14天报告有严重红斑。在第14天，1.2%克林霉素磷酸酯-2.5%BPO凝胶的平均红斑评分为0.9（相对于基线的平均变化为0.7），0.1%阿达帕林-2.5%BPO凝胶的平均红斑评分为1.4（相对于基线的平均变化为1.3）（第6 - 14天，P < 0.05）。干燥情况也有类似结果。平均评分分别为0.5（相对于基线的平均变化为0.4）和1.0（相对于基线的平均变化为1.0）（第6 - 14天，P < 0.05）。自我评估、TEWL和角质层测量结果证实了研究者的临床评估。1.
