环吡酮凝胶用于头皮脂溢性皮炎。

Ciclopirox gel for seborrheic dermatitis of the scalp.

作者信息

Aly Raza, Katz H Irving, Kempers Steven E, Lookingbill Donald P, Lowe Nicholas, Menter Alan, Morman Manuel, Savin Ronald C, Wortzman Mitchell

机构信息

Department of Dermatology, University of California San Francisco, San Francisco, CA, USA.

出版信息

Int J Dermatol. 2003 Sep;42 Suppl 1:19-22. doi: 10.1046/j.1365-4362.42.s1.5.x.

DOI:10.1046/j.1365-4362.42.s1.5.x

PMID:12895183

Abstract

BACKGROUND

Seborrheic dermatitis is a common inflammatory skin disorder that usually occurs in patients with pre-existing seborrhea. The etiology of seborrheic dermatitis is uncertain. Typically, sites dense with sebaceous glands support growth of the lipophilic yeast Malassezia furfur. Ciclopirox (Loprox) gel is a hydroxypyridone, broad-spectrum antifungal agent proven effective against the yeast M. furfur.

OBJECTIVE

A multicenter, randomized, double-blind, vehicle controlled study of 178 subjects evaluated the efficacy of ciclopirox gel in treating seborrheic dermatitis of the scalp.

METHODS

One hundred and seventy-eight subjects were randomized to apply either ciclopirox gel 0.77% twice daily, or vehicle twice daily for 28 days. Subjects' signs and symptoms of severity (erythema, scaling, pruritus and burning) were rated on a scale of 0-3 (none to severe); for inclusion, a minimum score of 4, for the sum of the individual ratings was required. Efficacy evaluations were performed at baseline, days 4, 8, 15, 22, 29, and at end-point (final visit, up to day 33). The primary efficacy variable was clinical response assessed by a global improvement, based on a scale of 0-5 (100% clearance to flare of treatment area). Changes in signs/symptoms severity scores within the target lesion were also evaluated.

RESULTS

Global evaluation scores demonstrated that significantly more ciclopirox-treated subjects achieved over 75% improvement compared with vehicle at days 22, 29, and endpoint (P < 0.01). Change-from-baseline mean score for total signs and symptoms was significantly greater in ciclopirox subjects compared with vehicle subjects at the same time points as above (P < 0.001), as well as day 15 (P < 0.01). Twenty-nine percent of subjects rated ciclopirox as having excellent cosmetic acceptability. There were only mild adverse events, with the most common being burning sensation in 13% of ciclopirox subjects and 9% of vehicle subjects.

CONCLUSION

Ciclopirox gel is effective and safe in the treatment of seborrheic dermatitis of the scalp.

摘要

背景

脂溢性皮炎是一种常见的炎症性皮肤病，通常发生在已有皮脂溢出的患者中。脂溢性皮炎的病因尚不确定。通常，皮脂腺密集的部位有利于亲脂性酵母糠秕马拉色菌的生长。环吡酮（Loprox）凝胶是一种羟基吡啶酮类广谱抗真菌剂，已被证明对酵母糠秕马拉色菌有效。

目的

一项针对178名受试者的多中心、随机、双盲、赋形剂对照研究评估了环吡酮凝胶治疗头皮脂溢性皮炎的疗效。

方法

178名受试者被随机分为两组，分别每天两次涂抹0.77%环吡酮凝胶或赋形剂，持续28天。对受试者的严重程度体征和症状（红斑、脱屑、瘙痒和灼痛）按0至3级（无至严重）进行评分；纳入标准为个体评分总和的最低分为4分。在基线、第4、8、15、22、29天以及终点（最后一次访视，最长至第33天）进行疗效评估。主要疗效变量是基于0至5级（治疗区域100%清除至复发）的整体改善情况评估的临床反应。还评估了目标皮损内体征/症状严重程度评分的变化。

结果

整体评估评分显示，在第22、29天和终点时，与赋形剂组相比，使用环吡酮治疗的受试者中有显著更多的人改善超过75%（P < 0.01）。在上述相同时间点以及第15天（P < 0.01），环吡酮组受试者总体征和症状的基线平均变化评分显著高于赋形剂组受试者（P < 0.001）。29%的受试者认为环吡酮的美容可接受性极佳。仅出现轻度不良事件，最常见的是13%使用环吡酮的受试者和9%使用赋形剂的受试者出现灼痛。