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.

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 Cutibacterium acnes, 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 P. acnes, 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 C. acnes and deeper follicular issues, promoting healthier skin and reducing acne-related symptoms.