含甘油和石蜡的润肤剂对中重度尿毒症皮肤干燥症的长期疗效和耐受性:3 期随机研究。

IF 3.5 3区 医学 Q1 DERMATOLOGY
Dermatology and Therapy Pub Date : 2024-11-01 Epub Date: 2024-10-18 DOI:10.1007/s13555-024-01287-w
Jacek C Szepietowski, Lajos Kemeny, Thomas Mettang, Petr Arenberger
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引用次数: 0

摘要

简介:尿毒症角化病和慢性肾病相关性瘙痒症(CKD-aP)患者对有效的局部疗法的需求尚未得到满足。一项三期研究评估了一种含有 15% 甘油和 10% 石蜡的润肤剂(V0034CR)的长期疗效和耐受性:在这项随机、双盲、两组平行、载体对照的研究中,中重度尿毒症患者被随机分配到每天使用一次 V0034CR 或载体对照,为期 28 天(I 期)。随后是≤21天的无治疗期(II期),然后所有患者接受V0034CR开放标签治疗≥84天(III期)。研究结果包括第一阶段结束时的治疗反应(El Gammal's角化病严重程度评分)、工具性缩放测量(D-Squame技术)、第二阶段的复发时间、第三阶段的复发率、一段时间内的瘙痒严重程度、患者接受度和不良事件(AEs):意向治疗人群包括 235 名患者,他们在第一阶段随机接受了 V0034CR(118 人)或药物对照(117 人)治疗。第一阶段结束时,V0034CR 组有 71 名患者(60.2%)获得治疗应答,而药物对照组有 48 名患者(41.0%)获得治疗应答(p = 0.0041)。与此同时,鳞屑的总表面积也有了更大的减少(与药物对照组相比,p = 0.001)。在第二阶段,如果不进行治疗,鳞屑症会逐渐复发;然而,在第三阶段,在维持治疗的情况下,鳞屑症的缓解是持久的。V0034CR 和药物对照组对瘙痒严重程度的改善效果相当,这表明 V0034CR 的止瘙痒作用主要是通过其水包油乳剂基质发挥的。患者对 V0034CR 的接受度高,耐受性好;最常见的治疗相关不良反应是刺激或红斑(2.1%)、瘙痒加剧(1.3%)和涂抹部位出现水泡(0.9%):这些数据支持使用具有水合和闭塞特性的 V0034CR 来长期治疗中重度尿毒症性皮肤干燥症和 CKD-aP 患者:试验注册:ClinicalTrials.gov 识别码 NCT01084148;EudraCT 编号 2006-002201-31。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long-Term Efficacy and Tolerability of an Emollient Containing Glycerol and Paraffin for Moderate-to-Severe Uremic Xerosis: A Randomized Phase 3 Study.

Introduction: There is an unmet need for effective topical therapies for patients with uremic xerosis and chronic kidney disease-associated pruritus (CKD-aP). The long-term efficacy and tolerability of an emollient containing glycerol 15% and paraffin 10% (V0034CR) was evaluated in a phase 3 study.

Methods: In this randomized, double-blind, two-parallel group, vehicle-controlled study, patients with moderate-to-severe uremic xerosis were randomized to once-daily application of V0034CR or vehicle control for 28 days (period I). This was followed by a treatment-free period of ≤ 21 days (period II), then all patients received open-label treatment with V0034CR for ≥ 84 days (period III). Outcomes included treatment response at the end of period I (El Gammal's xerosis severity score), instrumental measures of scaling (D-Squame technique), time to relapse during period II, rate of recurrence during period III, pruritus severity over time, patient acceptability, and adverse events (AEs).

Results: The intent-to-treat population comprised 235 patients randomized to V0034CR (n = 118) or vehicle control (n = 117) during period I. Treatment response at the end of period I was achieved by 71 patients (60.2%) in the V0034CR group versus 48 (41.0%) with vehicle control (p = 0.0041). This coincided with greater reductions in the total surface area of squames (p = 0.001 vs vehicle control). Xerosis relapsed progressively without treatment in period II; however, remission was durable under maintenance therapy in period III. Improvements in pruritus severity were comparable between V0034CR and vehicle control, suggesting that the antipruritic effect of V0034CR was mainly exerted by its oil-in-water emulsion base. V0034CR had high patient acceptability and was well tolerated; the most common treatment-related AEs were irritation or erythema (2.1%), exacerbated pruritus (1.3%), and vesicles at the application site (0.9%).

Conclusion: These data support the use of V0034CR, with its hydrating and occlusive properties, for the long-term management of patients with moderate-to-severe uremic xerosis and CKD-aP.

Trial registration: ClinicalTrials.gov identifier NCT01084148; EudraCT number 2006-002201-31.

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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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