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基于羟丙基壳聚糖和辛酰甘氨酸钾的新产品治疗酒渣鼻的临床和仪器评估。

Clinical and instrumental assessment of the effects of a new product based on hydroxypropyl chitosan and potassium azeloyl diglycinate in the management of rosacea.

机构信息

San Gallicano Dermatological Institute, Rome, Italy.

出版信息

J Cosmet Dermatol. 2012 Mar;11(1):37-41. doi: 10.1111/j.1473-2165.2011.00598.x.

Abstract

BACKGROUND

Rosacea is a chronic inflammatory skin disease affecting mostly facial skin. Its origin is multifactorial. Important steps in its treatment are avoidance of any triggering factor and control of skin inflammation.

AIM

To assess the benefit of topical applications of a new product (P-3075).

PATIENTS/METHODS: A randomized, multicenter, double-blind, placebo-controlled, parallel-group, pilot study was carried out to evaluate the efficacy and tolerability of a cream (P-3075) based on 5% potassium azeloyl diglycinate (PAD, Azeloglicina(®)) and 1% hydroxypropyl chitosan (HPCH). Forty-two patients (rosacea stages I and II) were enrolled and randomized, 28 in the P-3075 group and 14 in the placebo group. They were asked to apply the cream twice daily for 4 weeks. The main assessments were the objective quantification of erythema and skin hydration using the Mexameter(®) and Corneometer(®) devices, respectively. Clinical signs and symptoms were evaluated on a four-point scale.

RESULTS

The P-3075 cream applied for 28 days was effective in skin protection by reducing erythema, evaluated both instrumentally and clinically. In addition, the clinical assessments of other symptoms such as flushing, stinging, and burning supported the beneficial effect of the P-3075 cream.

CONCLUSIONS

The anti-inflammatory and moisturizing effects of potassium azeloyl diglycinate combined with the protective properties of HPCH allow the new product to be a good candidate for controlling signs and symptoms of rosacea.

摘要

背景

酒渣鼻是一种影响面部皮肤的慢性炎症性皮肤病。其病因是多因素的。其治疗的重要步骤是避免任何触发因素和控制皮肤炎症。

目的

评估一种新产品(P-3075)的局部应用的益处。

患者/方法:进行了一项随机、多中心、双盲、安慰剂对照、平行组、初步研究,以评估基于 5%的钾阿佐基二甘氨酸(PAD,Azeloglicina®)和 1%羟丙基壳聚糖(HPCH)的乳膏(P-3075)的疗效和耐受性。共纳入 42 名(酒渣鼻 I 期和 II 期)患者并进行随机分组,28 名患者使用 P-3075 乳膏,14 名患者使用安慰剂乳膏。要求他们每天两次涂抹乳膏,持续 4 周。主要评估指标分别为 Mexameter®和 Corneometer®设备对红斑和皮肤水分的客观定量。临床体征和症状采用四点量表进行评估。

结果

应用 P-3075 乳膏 28 天可有效保护皮肤,减少红斑,仪器和临床评估均有效。此外,其他症状(如潮红、刺痛和灼热)的临床评估也支持 P-3075 乳膏的有益作用。

结论

阿佐基二甘氨酸的抗炎和保湿作用与 HPCH 的保护特性相结合,使新产品成为控制酒渣鼻症状的良好候选药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15ab/3488300/dd99987c0b24/jocd0011-0037-f1.jpg

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