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非交联透明质酸化合物治疗毛发角化病的疗效与安全性:一项自身对照随机临床试验。

Efficacy and safety of non-cross-linked hyaluronic acid compound in the treatment of keratosis pilaris: A split-body randomized clinical trial.

作者信息

Li Yao, Wang Shi-Wei, Liu Yan-Hua, Zou Mu-Yan, Wu Jia-Xu, Luo Sheng-Kang, Hong Wei-Jin

机构信息

Department of Plastic and Reconstructive Surgery, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.

Medical Department, Imeik Technology Development Co., Ltd, Beijing, China.

出版信息

J Cosmet Dermatol. 2024 Dec;23(12):3903-3910. doi: 10.1111/jocd.16532. Epub 2024 Aug 23.

Abstract

BACKGROUND

Keratosis pilaris (KP) is a prevalent benign dermatological condition characterized by small bumps at the hair follicles alongside surrounding redness, significantly impacting both aesthetics and mental well-being.

OBJECTIVE

This study investigated the potential benefits of a non-cross-linked hyaluronic acid (HA) compound for treating KP.

METHODS

A split-body, investigator-blinded, randomized, intraindividual comparative clinical trial was conducted. The non-cross-linked HA compound was injected into KP-affected regions on both upper arms. The treatment was delivered across four sessions scheduled at 4-week intervals. Blinded physicians and patients assessed differences in erythema, skin roughness, and overall scores between treated and control areas at the final follow-up visit. At the 12th and 24th weeks post-treatment, a four-point scale was utilized to assess subjects' perceived treatment efficacy. Additionally, dermoscopic images, histological alterations, and adverse events were monitored.

RESULTS

Physician assessments revealed a significant reduction in roughness and overall scores for treated areas compared to controls. Patient self-assessments also reflected improvements in roughness, redness, and overall scores for treated sides at the final visit, with 35.71% of patients demonstrating sustained improvement in redness and 71.43% reporting persistent improvements in roughness at 24th weeks post-treatment. The dermatoscopic examinations revealed a notable enhancement in both the quantity of follicular plugs and the extent of erythema among the subjects in the treatment group. Histopathological outcomes also demonstrated improvement.

CONCLUSION

This study suggests that the non-cross-linked HA compound effectively improves skin roughness and promotes hair shaft growth in KP treatment, demonstrating a favorable safety profile. These findings position it as a potentially viable alternative therapy in clinical practice.

摘要

背景

毛发角化病(KP)是一种常见的良性皮肤病,其特征为毛囊处出现小丘疹并伴有周围发红,对美观和心理健康均有显著影响。

目的

本研究调查了一种非交联透明质酸(HA)化合物治疗KP的潜在益处。

方法

进行了一项半体、研究者盲法、随机、个体内比较临床试验。将非交联HA化合物注射到双臂受KP影响的区域。治疗分四个疗程进行,间隔4周。在最后一次随访时,由盲法医生和患者评估治疗区域和对照区域在红斑、皮肤粗糙度和总体评分方面的差异。在治疗后第12周和第24周,采用四点量表评估受试者对治疗效果的感知。此外,还监测了皮肤镜图像、组织学改变和不良事件。

结果

医生评估显示,与对照组相比,治疗区域的粗糙度和总体评分显著降低。患者自我评估也反映出在最后一次就诊时,治疗侧的粗糙度、发红和总体评分有所改善,35.71%的患者在治疗后第24周发红持续改善,71.43%的患者报告粗糙度持续改善。皮肤镜检查显示,治疗组受试者的毛囊角栓数量和红斑程度均有显著改善。组织病理学结果也显示有改善。

结论

本研究表明,非交联HA化合物在治疗KP时可有效改善皮肤粗糙度并促进毛干生长,安全性良好。这些发现使其成为临床实践中一种潜在可行的替代疗法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e50b/11626356/114ce0d4462e/JOCD-23--g001.jpg

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