0.2%桃金娘醇局部制剂和 4%烟酰胺预防和治疗轻中度痤疮患者维 A 酸类药物所致皮炎的疗效和耐受性。

Efficacy and tolerability of topical 0.2% Myrtacine® and 4% vitamin PP for prevention and treatment of retinoid dermatitis in patients with mild to moderate acne.

机构信息

Department of Anesthesiology, Intensive Care and Dermatological Sciences, University of Milan, Milan, Italy.

出版信息

G Ital Dermatol Venereol. 2012 Oct;147(5):491-7.

Abstract

AIM

The aim of the present study was to evaluate the efficacy and tolerability of an emulsion of 0.2% Myrtacine® and 4% vitamin PP, compared with a simple emollient cream, in the treatment of retinoid dermatitis in patients with mild-to-moderate acne.

METHODS

This was a prospective, multicenter, open-label, non-randomised, parallel-group study. Patients (age 12-49 years; skin phototype I-IV) with mild-to-moderate acne, who were treated with a topical retinoid for at least one month and had developed skin irritation were assigned to one of the two following treatments: 0.2% Myrtacine® and 4% vitamin PP (N.=116) or a simple emollient cream (N.=48). Both treatments were administered twice daily, 1-1.5 hours after the application of the topical retinoid. Study endpoints were improvement in signs and symptoms of retinoid dermatitis, global efficacy, reduction in acne severity, overall clinical outcome, patient satisfaction and tolerability.

RESULTS

At day 28, compared with the simple emollient cream, 0.2% Myrtacine® and 4% vitamin PP significantly decreased signs (erythema, dryness/scaling, oedema, and roughness) and symptoms (itching, stinging, burning sensation and discomfort) of retinoid dermatitis (P<0.01). In addition, compared with the simple emollient cream, 0.2% Myrtacine® and 4% vitamin PP decreased acne severity in a significantly greater proportion of patients (P=0.023) and was associated with a better clinical outcome (mild, intermediate, clinically relevant or global improvement; P<0.001). 0.2% Myrtacine® and 4% vitamin PP was also associated with greater patient satisfaction and was better tolerated than the simple emollient cream.

CONCLUSION

0.2% Myrtacine® and 4% vitamin PP was effective and well tolerated in the treatment of retinoid dermatitis in patients with mild-to-moderate acne and significantly improved acne severity and overall clinical outcome.

摘要

目的

本研究旨在评估 0.2%Myrtacine®和 4%维生素 PP 乳液与简单的保湿霜相比，在治疗轻中度痤疮患者的类维生素 A 皮炎中的疗效和耐受性。

方法

这是一项前瞻性、多中心、开放标签、非随机、平行组研究。年龄在 12-49 岁之间、皮肤光型 I-IV 级、接受外用类维生素 A 治疗至少一个月且出现皮肤刺激的轻中度痤疮患者，被分配至以下两种治疗方案之一：0.2%Myrtacine®和 4%维生素 PP（N=116）或简单保湿霜（N=48）。两种治疗方案均每日两次，在应用外用类维生素 A 后 1-1.5 小时进行。研究终点为改善类维生素 A 皮炎的体征和症状、总体疗效、痤疮严重程度降低、总体临床疗效、患者满意度和耐受性。

结果

与简单保湿霜相比，在第 28 天，0.2%Myrtacine®和 4%维生素 PP 显著降低了类维生素 A 皮炎的体征（红斑、干燥/脱屑、水肿和粗糙）和症状（瘙痒、刺痛、烧灼感和不适）（P<0.01）。此外，与简单保湿霜相比，0.2%Myrtacine®和 4%维生素 PP 使更多的患者痤疮严重程度得到显著改善（P=0.023），并且与更好的临床疗效相关（轻度、中度、临床相关或总体改善；P<0.001）。0.2%Myrtacine®和 4%维生素 PP 还与更高的患者满意度相关，且与简单保湿霜相比耐受性更好。