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含二氯尼特胺™痤疮套装(面部精华液和洁面乳)方案用于成人面部痤疮协同管理的疗效、安全性及使用耐受性的临床评估

Clinical Evaluation of the Efficacy, Safety, and In-Use Tolerability of a Diacnemide™-Containing Acne Kit (Facial Serum and Cleanser) Regimen for the Synergistic Management of Facial Acne in Adults.

作者信息

Patel Maheshvari N, Patel Nayan K, Merja Apeksha M, Patnaik Saurav

机构信息

Clinical Research, NovoBliss Research Private Limited, Ahmedabad, IND.

Pharmacology, Swaminarayan University, Ahmedabad, IND.

出版信息

Cureus. 2024 Sep 23;16(9):e69968. doi: 10.7759/cureus.69968. eCollection 2024 Sep.

DOI:10.7759/cureus.69968
PMID:39445245
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11497064/
Abstract

Introduction Acne is a common inflammatory condition characterized by comedones, papules, and pustules, often resulting from increased sebum production influenced by hormones such as insulin-like growth factor-1 and androgens. Factors like , medications, sun exposure, cosmetics, and genetics exacerbate acne. This study aims to assess the safety and effectiveness of a novel acne treatment regimen, including a cleanser and serum containing Diacnemide™ (manufactured by Beaucience India Private Limited, Faridabad, India), in improving acne symptoms in adults. Methods This prospective, interventional, open-label, single-center, single-arm clinical study was designed to evaluate the safety, efficacy, and in-use tolerability of the test treatment regimen (serum + cleanser) for facial acne. Ethical approval was obtained from the Independent Ethics Committee, and all participants provided written consent. The study assessed changes in the severity of acne by dermatological assessment using the Investigator's Global Assessment (IGA) scale, changes in inflammatory and non-inflammatory lesions, skin hydration, sebum levels, and facial blemishes using various bioinstrumentations from Courage+Khazaka Electronic GmbH, Germany - Visiopor® PP34N, Corneometer® CM 825, Sebumeter® SM 815, and Mexameter® MX 18, respectively. Evaluations were conducted at baseline, T15 minutes, day 8, and day 15 post-usage. Statistical analyses were performed using SPSS (version 29.0.1.0) and Microsoft® Excel 2019 software, with results reported using p-values and confidence intervals at a 5% significance level. Results Porphyrin measurements showed significant reductions over time, with a 27.18% decrease in quantity and a 39.86% reduction by day 15 (p < 0.0001). Porphyrin values dropped by 2.61% after 15 minutes and 7.82% by day 15 (p < 0.05). Skin hydration increased significantly, with a 97.54% increment after 15 minutes and a 102.74% increment by day 15 (p < 0.0001). Sebum levels were restored to normal levels with the dry skin observed at baseline, showing a 34.45% improvement on day 8 and 75.75% by day 15 (p < 0.0001). Facial dark spots were reduced by 10.66% by day 8 and 14.64% by day 15 (p < 0.0001), and erythema levels decreased significantly. Acne severity showed notable improvement, with 50% of the subjects having moderate acne at baseline, reduced to 20.69% with mild acne, and 79.31% with almost clear skin by day 15. Subject responses indicated high satisfaction, with 100% agreeing on the test treatment's effectiveness in reducing acne, oiliness, and inflammation and improving hydration and skin texture. Conclusion The ThriveCo acne regimen (serum + cleanser) manufactured by Anveya Living Private Limited, India, is both effective and safe for treating facial acne in healthy adults with acne. It significantly reduces porphyrin size and quantity, indicating a strong inhibition of , and visibly improves dark spots and skin hydration. The components - Diacnemide™ and zinc pyrrolidone carboxylic acid - in the cleanser regulate sebum production and provide anti-inflammatory benefits, while the serum, containing Diacnemide™ and niacinamide, enhances skin barrier function and balances lipids. The synergistic effects of the ThriveCo Goodbye Acne Cleanser and Serum in this regimen effectively target surface bacteria like and deeper follicular issues, promoting healthier skin and reducing acne-related symptoms.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/d389484c23ac/cureus-0016-00000069968-i06.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/0de048883c99/cureus-0016-00000069968-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/3d6497e876da/cureus-0016-00000069968-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/dd09cfae0f31/cureus-0016-00000069968-i03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/811b92306456/cureus-0016-00000069968-i04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/0ec17e2466c2/cureus-0016-00000069968-i05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/d389484c23ac/cureus-0016-00000069968-i06.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/0de048883c99/cureus-0016-00000069968-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/3d6497e876da/cureus-0016-00000069968-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/dd09cfae0f31/cureus-0016-00000069968-i03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/811b92306456/cureus-0016-00000069968-i04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/0ec17e2466c2/cureus-0016-00000069968-i05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9025/11497064/d389484c23ac/cureus-0016-00000069968-i06.jpg
摘要

引言

痤疮是一种常见的炎症性疾病,其特征为粉刺、丘疹和脓疱,通常是由胰岛素样生长因子-1和雄激素等激素影响皮脂分泌增加所致。饮食、药物、日晒、化妆品和遗传等因素会加重痤疮。本研究旨在评估一种新型痤疮治疗方案(包括一种洁面产品和含有Diacnemide™的精华液,由印度法里达巴德的Beaucience India Private Limited生产)改善成人痤疮症状的安全性和有效性。

方法

本前瞻性、干预性、开放标签、单中心、单臂临床研究旨在评估测试治疗方案(精华液+洁面产品)对面部痤疮的安全性、疗效和使用耐受性。获得了独立伦理委员会的伦理批准,所有参与者均提供了书面同意书。该研究通过使用研究者整体评估(IGA)量表进行皮肤科评估来评估痤疮严重程度的变化,分别使用德国Courage+Khazaka Electronic GmbH的各种生物仪器——Visiopor® PP34N、Corneometer® CM 825、Sebumeter® SM 815和Mexameter® MX 18来评估炎症性和非炎症性皮损、皮肤水合作用、皮脂水平和面部瑕疵的变化。在基线、使用后15分钟、第8天和第15天进行评估。使用SPSS(版本29.0.1.0)和Microsoft® Excel 2019软件进行统计分析,结果以p值和95%置信区间报告。

结果

卟啉测量结果显示,随着时间的推移有显著降低,到第15天数量减少了27.18%,降幅为39.86%(p<0.0001)。15分钟后卟啉值下降了2.61%,到第15天下降了7.82%(p<0.05)。皮肤水合作用显著增加,15分钟后增加了97.54%,到第15天增加了102.74%(p<0.0001)。皮脂水平恢复到基线时观察到的干性皮肤的正常水平,第8天改善了34.45%,到第15天改善了75.75%(p<0.0001)。面部黑斑到第8天减少了10.66%,到第15天减少了14.64%(p<0.0001),红斑水平显著降低。痤疮严重程度有显著改善,基线时有50%的受试者患有中度痤疮,到第15天降至20.69%为轻度痤疮,79.31%的受试者皮肤几乎清洁。受试者反馈表明满意度很高,100%的人认同测试治疗方案在减少痤疮、油腻感和炎症以及改善水合作用和皮肤质地方面的有效性。

结论

印度Anveya Living Private Limited生产的ThriveCo痤疮治疗方案(精华液+洁面产品)对患有痤疮的健康成人治疗面部痤疮既有效又安全。它能显著减小卟啉大小并减少其数量,表明对[此处原文缺失相关内容]有强烈抑制作用,还能明显改善黑斑和皮肤水合作用。洁面产品中的成分——Diacnemide™和吡咯烷酮羧酸锌可调节皮脂分泌并提供抗炎益处,而含有Diacnemide™和烟酰胺的精华液可增强皮肤屏障功能并平衡脂质。该治疗方案中ThriveCo告别痤疮洁面产品和精华液的协同作用有效针对如[此处原文缺失相关内容]等表面细菌和更深层的毛囊问题,促进皮肤更健康并减轻痤疮相关症状。

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