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克林霉素/维甲酸和过氧化苯甲酰/阿达帕林联合痤疮产品应用后皮肤刺激性的双盲、随机、双侧比较。

A double-blind, randomized, bilateral comparison of skin irritancy following application of the combination acne products clindamycin/tretinoin and benzoyl peroxide/adapalene.

作者信息

Goreshi Renato, Samrao Aman, Ehst Benjamin D

机构信息

Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.

出版信息

J Drugs Dermatol. 2012 Dec;11(12):1422-6.

Abstract

BACKGROUND

The use of topical medications for acne vulgaris is often limited by their irritant properties. Newer combination preparations are available and offer convenience, but irritant potential may still be a hindrance, perhaps more so with the combination of 2 agents. Few studies have compared these formulations directly for tolerability.

OBJECTIVE

We sought to compare the tolerability of 2 combination topical acne products, clindamycin 1.2%-tretinoin 0.025% (CLIN/RA) gel and benzoyl peroxide 2.5%-adapalene 0.1% (BPO/ADA) gel.

METHODS

CLIN/RA and BPO/ADA were applied daily to opposite sides of a subject's face for 21 days in a double-blinded fashion. Investigators' Global Assessments and study subject self-assessments of burning/stinging, itching, erythema, and dryness/scaling were collected. Transepidermal water loss (TEWL) was also measured as an objective measure of skin irritation. A mixed model analysis and repeated-measures analysis of variance were used to compare outcomes for both acne formulations.

RESULTS

CLIN/RA produced significantly less burning/stinging than BPO/ADA (P<.001) as well as significantly less pruritus than BPO/ ADA (P<.001). BPO/ADA caused significantly more TEWL than CLIN/RA (P=.005). There was no significant difference in the amount of erythema or the amount of dryness/scaling caused by either formulation.

CONCLUSION

CLIN/RA produced significantly less skin irritancy and TEWL than BPO/ADA.

摘要

背景

外用药物治疗寻常痤疮常因其刺激性而受到限制。新型复方制剂已上市且使用方便,但仍可能存在刺激风险,两种药物联合使用时可能更明显。很少有研究直接比较这些制剂的耐受性。

目的

我们旨在比较两种外用痤疮复方产品,即1.2%克林霉素-0.025%维甲酸(CLIN/RA)凝胶和2.5%过氧化苯甲酰-0.1%阿达帕林(BPO/ADA)凝胶的耐受性。

方法

采用双盲法,将CLIN/RA和BPO/ADA每日分别涂抹于受试者面部的对侧,持续21天。收集研究者的整体评估以及研究对象对灼烧/刺痛、瘙痒、红斑和干燥/脱屑的自我评估。还测量经表皮水分流失(TEWL)作为皮肤刺激的客观指标。使用混合模型分析和重复测量方差分析来比较两种痤疮制剂的结果。

结果

CLIN/RA产生的灼烧/刺痛明显少于BPO/ADA(P<0.001),瘙痒也明显少于BPO/ADA(P<0.001)。BPO/ADA导致的TEWL明显多于CLIN/RA(P=0.005)。两种制剂引起的红斑量或干燥/脱屑量没有显著差异。

结论

与BPO/ADA相比,CLIN/RA产生的皮肤刺激性和TEWL明显更少。

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