Rationale for the topical use of a combination of diphenhydramine hydrochloride and lidocaine hydrochloride in the symptomatic treatment of histamine-dependent allergic and inflammatory skin reactions, accompanied by pruritus.

IF 1.4 4区 医学 Q3 ALLERGY
Postepy Dermatologii I Alergologii Pub Date : 2024-08-01 Epub Date: 2024-06-30 DOI:10.5114/ada.2024.141098
Zbigniew Doniec, Małgorzata Sielska, Tomasz Wróbel, Roman J Nowicki
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引用次数: 0

Abstract

Introduction: Allergic reactions caused by external factors are treated with medicinal products containing antihistamines, therefore their action is delayed in time. Combination of antihistamines and fast-acting analgesics may help to reduce discomfort associated with cutaneous reactions.

Aim: To evaluate efficacy and safety of the combination topical gel containing diphenhydramine hydrochloride 20 mg/g and lidocaine hydrochloride 10 mg/g over placebo in the treatment of local skin inflammatory and allergic reactions.

Material and methods: A study was a single-centre, single-dose, randomized, double-blind, two-treatment, two-period, two-sequence cross-over clinical trial (n = 44) in healthy subjects. Local skin inflammatory and allergic lesions were induced by the provocative test with histamine in healthy subjects. For all parameters recorded with the Visual Analogue Scale (VAS), the area under the curve (AUC) was calculated and the peak itch intensity was noted for every subject in response to the skin prick test. The primary endpoint of the study was the difference in AUC calculated from the intensity of itch for test product A (diphenhydramine hydrochloride 20 mg/g and lidocaine hydrochloride 10 mg/g, gel) and placebo product B.

Results: The results revealed that itching intensity AUC was significantly greater for product B than for product A, on average by 2.05 points. A decrease in itching intensity was observed from the second minute after application of the test product.

Conclusions: The study provided evidence for differences in efficacy between the product tested and placebo.

局部使用盐酸苯海拉明和盐酸利多卡因复方制剂对组胺依赖性过敏和炎症性皮肤反应(伴有瘙痒)进行对症治疗的理由。
引言由外部因素引起的过敏反应通常使用含有抗组胺剂的药物进行治疗,因此抗组胺剂的作用在时间上具有延迟性。目的:评估含盐酸苯海拉明 20 毫克/克和盐酸利多卡因 10 毫克/克的联合外用凝胶治疗局部皮肤炎症和过敏反应的疗效和安全性:研究是一项单中心、单剂量、随机、双盲、两疗程、两阶段、两序列交叉临床试验(n = 44),对象为健康受试者。健康受试者通过组胺激发试验诱发局部皮肤炎症和过敏性病变。用视觉模拟量表(VAS)记录所有参数,计算曲线下面积(AUC),并记录每个受试者在皮肤点刺试验中的峰值瘙痒强度。研究的主要终点是根据试验产品 A(盐酸苯海拉明 20 毫克/克和盐酸利多卡因 10 毫克/克,凝胶)和安慰剂产品 B 的瘙痒强度计算出的 AUC 差异:结果显示,产品 B 的瘙痒强度 AUC 明显高于产品 A,平均高出 2.05 个点。从使用测试产品后的第二分钟开始,瘙痒强度开始下降:该研究为测试产品与安慰剂之间的疗效差异提供了证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
2.60
自引率
7.10%
发文量
107
审稿时长
6-12 weeks
期刊介绍: Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii is a bimonthly aimed at allergologists and dermatologists.
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