Efficacy of a Multi-lamellar Emulsion Containing a Synthetic Sphingosine Kinase 1 Activator and Pseudoceramide in Patients with Atopic Dermatitis: A Randomized Controlled Trial.

IF 3.5 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-09-01 Epub Date: 2024-08-30 DOI:10.1007/s13555-024-01254-5

So Yeon Lee, Jin Seo Park, Daehwan Kim, Wonseok Jeong, Chenghwan Hwang, Hye One Kim, Chun Wook Park, Bo Young Chung

{"title":"Efficacy of a Multi-lamellar Emulsion Containing a Synthetic Sphingosine Kinase 1 Activator and Pseudoceramide in Patients with Atopic Dermatitis: A Randomized Controlled Trial.","authors":"So Yeon Lee, Jin Seo Park, Daehwan Kim, Wonseok Jeong, Chenghwan Hwang, Hye One Kim, Chun Wook Park, Bo Young Chung","doi":"10.1007/s13555-024-01254-5","DOIUrl":null,"url":null,"abstract":"Introduction: Patients with atopic dermatitis (AD) have impaired barrier function, which decreases skin hydration, weakens their defense against microorganisms, and culminates in increased inflammatory responses. Here, we conducted a clinical trial to evaluate the efficacy of a multi-lamellar emulsion (MLE) containing the pseudoceramide PC-9S and a synthetic sphingosine kinase 1 (SPHK1) activator, Defensamide™, in improving mild-to-moderate atopic dermatitis.Methods: Forty patients aged ≥ 2 years were randomized into a combined-therapy group treated with the MLE containing PC-9S and Defensamide™ plus a topical corticosteroid and a topical-corticosteroid-only group. Assessments based on therapeutic methods included the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), transepidermal water loss (TEWL), stratum corneum hydration (SCH), skin dryness, a visual analogue scale (VAS) of itchiness, a VAS of sleep disturbance, patient satisfaction, and the Dermatology Life Quality Index (DLQI).Results: Thirty-eight patients completed this study. In the combined-therapy group, significant improvements in clinical and instrumental measures such as EASI scores, skin hydration, and skin dryness were noted at 4 weeks compared to baseline, but such improvements were not noted in the topical corticosteroid-only group. Subjective assessments of itching and sleep disturbance and DLQI scores also showed significant improvements in the combined-therapy group.Conclusion: Combined therapy with the MLE containing Defensamide™ and PC-9S and with topical corticosteroid demonstrated superior clinical outcomes compared with topical corticosteroid monotherapy. Our findings underscore the potential of MLE-containing formulations as effective adjunctive therapies for AD, offering both objective and subjective symptomatic relief and enhancing patients' quality of life.","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2591-2605"},"PeriodicalIF":3.5000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393266/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-024-01254-5","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/30 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: Patients with atopic dermatitis (AD) have impaired barrier function, which decreases skin hydration, weakens their defense against microorganisms, and culminates in increased inflammatory responses. Here, we conducted a clinical trial to evaluate the efficacy of a multi-lamellar emulsion (MLE) containing the pseudoceramide PC-9S and a synthetic sphingosine kinase 1 (SPHK1) activator, Defensamide™, in improving mild-to-moderate atopic dermatitis.

Methods: Forty patients aged ≥ 2 years were randomized into a combined-therapy group treated with the MLE containing PC-9S and Defensamide™ plus a topical corticosteroid and a topical-corticosteroid-only group. Assessments based on therapeutic methods included the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), transepidermal water loss (TEWL), stratum corneum hydration (SCH), skin dryness, a visual analogue scale (VAS) of itchiness, a VAS of sleep disturbance, patient satisfaction, and the Dermatology Life Quality Index (DLQI).

Results: Thirty-eight patients completed this study. In the combined-therapy group, significant improvements in clinical and instrumental measures such as EASI scores, skin hydration, and skin dryness were noted at 4 weeks compared to baseline, but such improvements were not noted in the topical corticosteroid-only group. Subjective assessments of itching and sleep disturbance and DLQI scores also showed significant improvements in the combined-therapy group.

Conclusion: Combined therapy with the MLE containing Defensamide™ and PC-9S and with topical corticosteroid demonstrated superior clinical outcomes compared with topical corticosteroid monotherapy. Our findings underscore the potential of MLE-containing formulations as effective adjunctive therapies for AD, offering both objective and subjective symptomatic relief and enhancing patients' quality of life.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

含合成蛋白鞘氨酶 1 激活剂和假丝酰胺的多胶束乳液对特应性皮炎患者的疗效：随机对照试验

简介：特应性皮炎（AD）患者的屏障功能受损，从而降低了皮肤的水合作用，削弱了对微生物的防御能力，并最终导致炎症反应加剧。在此，我们进行了一项临床试验，以评估含有伪神经酰胺 PC-9S 和合成鞘氨醇激酶 1 (SPHK1) 激活剂 Defensamide™ 的多胶束乳液 (MLE) 在改善轻度至中度特应性皮炎方面的疗效：40名年龄≥2岁的患者被随机分为使用含有PC-9S和Defensamide™的MLE以及外用皮质类固醇的联合治疗组和仅外用皮质类固醇组。根据治疗方法进行的评估包括湿疹面积和严重程度指数（EASI）、研究者全球评估（IGA）、经表皮失水率（TEWL）、角质层水合作用（SCH）、皮肤干燥度、瘙痒视觉模拟量表（VAS）、睡眠障碍视觉模拟量表、患者满意度和皮肤科生活质量指数（DLQI）：38名患者完成了这项研究。与基线相比，联合疗法组患者的临床和工具测量指标（如 EASI 评分、皮肤水合度和皮肤干燥度）在 4 周时均有显著改善，但只使用外用皮质类固醇激素的治疗组患者则没有这种改善。对瘙痒和睡眠障碍的主观评估以及 DLQI 评分也显示，联合疗法组的病情有显著改善：结论：与外用皮质类固醇激素单药治疗相比，含有 Defensamide™ 和 PC-9S 的 MLE 与外用皮质类固醇激素联合治疗的临床疗效更佳。我们的研究结果表明，含 MLE 的制剂有可能成为治疗 AD 的有效辅助疗法，既能缓解主客观症状，又能提高患者的生活质量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

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.