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一项评估冷等离体用于酒渣鼻的应答和耐受性的前瞻性随机对照初步研究。

A Prospective Randomized Controlled Pilot Study to Assess the Response and Tolerability of Cold Atmospheric Plasma for Rosacea.

机构信息

Clinic and Policlinic for Dermatology and Venereology, University Medical Center Rostock, Rostock, Germany.

Institute for Biostatistics and Informatics in Medicine and Ageing Research, University Medical Center Rostock, Rostock, Germany.

出版信息

Skin Pharmacol Physiol. 2023;36(4):205-213. doi: 10.1159/000533190. Epub 2023 Jul 25.

Abstract

INTRODUCTION

Rosacea is a common, facial, chronic inflammatory skin disease. Due to its complex pathogenesis, adequate therapy of rosacea can be challenging. An innovative recent therapeutic tool is cold atmospheric plasma (CAP), which is already established in the treatment of chronic wounds and promising in different other skin diseases.

METHODS

In a split-face pilot study we investigated dielectric-barrier-discharged CAP in erythemato-telangiectatic (ETR) and/or papulopustular rosacea (PPR). CAP treatment was applied on lesional skin of a randomized side once daily (90 s/area) for 6 weeks. The other untreated side served as control. Co-primary endpoints were ≥1 improvement of the Investigator Global Assessment (IGA) score on the treated side compared to control and a decline of the Dermatology Life Quality Index (DLQI) after 6 weeks. Secondary endpoints included inflammatory lesion count (papules and pustules), skin redness intensity and erythema size. Adverse events (AEs) were recorded constantly. Additionally, participants were weekly assessed for symptoms, skin condition, trigger factors, skin care, treatment success, and local tolerance parameters. All p values were calculated using the Wilcoxon signed-rank test.

RESULTS

Twelve subjects (ETR, n = 3; ETR and PPR, n = 9) completed the study. DLQI was significantly improved after 6 weeks (p = 0.007). On the CAP-treated side, lesions (p = 0.007) and erythema size (p = 0.041) were significantly reduced compared to the control. IGA (p = 0.2) and skin redness intensity (p = 0.5) did not differ significantly between control and CAP-treated side. No serious AEs occurred and treatment was well tolerated.

CONCLUSION

CAP is a promising new treatment of rosacea, especially for PPR.

摘要

简介

酒渣鼻是一种常见的面部慢性炎症性皮肤疾病。由于其发病机制复杂,酒渣鼻的充分治疗具有挑战性。一种创新的治疗工具是冷等离子体(CAP),它已在慢性伤口治疗中得到应用,并在其他不同皮肤疾病中具有广阔的应用前景。

方法

在一项分割面部的试点研究中,我们研究了电介质阻挡放电 CAP 在红斑毛细血管扩张型(ETR)和/或丘疹脓疱型酒渣鼻(PPR)中的应用。CAP 治疗以 90 秒/区域的频率,每天在病变皮肤的随机一侧进行(共 6 周)。另一侧未治疗的皮肤作为对照。主要终点是与对照相比,治疗侧的研究者整体评估(IGA)评分改善≥1,以及 6 周后皮肤病生活质量指数(DLQI)下降。次要终点包括炎症性皮损计数(丘疹和脓疱)、皮肤发红强度和红斑大小。持续记录不良事件(AE)。此外,参与者每周评估症状、皮肤状况、触发因素、皮肤护理、治疗效果和局部耐受参数。所有 p 值均使用 Wilcoxon 符号秩检验计算。

结果

12 名受试者(ETR 型,n = 3;ETR 型和 PPR 型,n = 9)完成了研究。治疗 6 周后,DLQI 显著改善(p = 0.007)。与对照组相比,CAP 治疗侧的皮损(p = 0.007)和红斑大小(p = 0.041)显著减少。IGA(p = 0.2)和皮肤发红强度(p = 0.5)在对照组和 CAP 治疗侧之间无显著差异。未发生严重 AE,治疗耐受良好。

结论

CAP 是酒渣鼻的一种有前途的新治疗方法,尤其适用于 PPR。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a453/10652650/9f81c33ab6c6/spp-2023-0036-0004-533190_F01.jpg

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