Safety and Clinical Efficacy of KūlarisTM, an Herbal Supplement for Mild to Severe Acne Vulgaris - A 12-Week Randomized, Double Blind, Placebo-Controlled Study.

IF 2.2 4区 医学 Q3 DERMATOLOGY
Clinical, Cosmetic and Investigational Dermatology Pub Date : 2025-09-26 eCollection Date: 2025-01-01 DOI:10.2147/CCID.S539004
Heggar Venkataramana Sudeep, Divya Chandradhara, Kodimule Shyamprasad
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引用次数: 0

Abstract

Purpose: There is a growing interest in nutraceutical supplements for ameliorating skin disorders owing to their multifaceted role and tolerability. In this study, we investigated the safety and efficacy of a unique herbal formulation (KūlarisTM) containing Commiphora wightii (guggul) and Amorphophallus konjac tuber extracts for the treatment of mild-to-severe acne.

Patients and methods: In a randomized, placebo-controlled, parallel-group study design, 100 male and female subjects (18-40 years) with mild to severe acne were allocated (1:1 ratio) to receive 450 mg capsules of either Kūlaris or placebo once daily for 12 weeks.

Results: Kūlaris treatment markedly reduced acne severity, with the majority of subjects achieving success in the Investigator Global Assessment (IGA) score (odds ratio = 7.88, p<0.0001) compared with placebo. Kūlaris administration significantly reduced the inflammatory and non-inflammatory acne lesion counts (p<0.0001 vs placebo). The Cardiff Acne Disability Index (CADI) score was reduced significantly in the Kūlaris group after 6 (p<0.0001) and 12 weeks (p<0.001) from baseline, indicating an improvement in quality of life. However, the subjective assessment showed no significant changes in general skin health measures, such as skin quality, color, wrinkle reduction, and skin hydration, in either group. Kūlaris was well tolerated among study participants, with no reported adverse effects or observable clinical signs throughout the intervention period.

Conclusion: This study provides compelling evidence to support the potential use of Kūlaris as a therapeutic supplement or an adjunctive therapy to treatment of acne vulgaris.

KūlarisTM,一种治疗轻至重度寻常痤疮的草药补充剂的安全性和临床疗效——一项为期12周的随机、双盲、安慰剂对照研究。
目的:由于营养保健品的多方面作用和耐受性,人们对改善皮肤疾病的营养保健品越来越感兴趣。在这项研究中,我们研究了一种独特的草药配方(KūlarisTM),其中含有紫金花(guggul)和魔芋块茎提取物治疗轻至重度痤疮的安全性和有效性。患者和方法:在一项随机、安慰剂对照、平行组研究设计中,100名患有轻度至重度痤疮的男性和女性受试者(18-40岁)被分配(1:1比例)接受450毫克Kūlaris胶囊或安慰剂胶囊,每天一次,持续12周。结果:Kūlaris治疗显著降低了痤疮的严重程度,大多数受试者在研究者总体评估(IGA)评分中取得了成功(优势比= 7.88,ppppp)。结论:本研究提供了令人信服的证据,支持Kūlaris作为治疗寻常痤疮的补充治疗或辅助治疗的潜在应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
2.80
自引率
4.30%
发文量
353
审稿时长
16 weeks
期刊介绍: Clinical, Cosmetic and Investigational Dermatology is an international, peer-reviewed, open access journal that focuses on the latest clinical and experimental research in all aspects of skin disease and cosmetic interventions. Normal and pathological processes in skin development and aging, their modification and treatment, as well as basic research into histology of dermal and dermal structures that provide clinical insights and potential treatment options are key topics for the journal. Patient satisfaction, preference, quality of life, compliance, persistence and their role in developing new management options to optimize outcomes for target conditions constitute major areas of interest. The journal is characterized by the rapid reporting of clinical studies, reviews and original research in skin research and skin care. All areas of dermatology will be covered; contributions will be welcomed from all clinicians and basic science researchers globally.
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