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

Heggar Venkataramana Sudeep,1 Divya Chandradhara,2 Kodimule Shyamprasad1 1Department of Biomedicinal Research, R&D Center for Excellence, Vidya Herbs Pvt Ltd., Bengaluru, Karnataka, India; 2Bioagile Therapeutics Pvt Ltd., Bengaluru, Karnataka, IndiaCorrespondence: Heggar Venkataramana Sudeep, Department of Biomedicinal Research, R&D Center for Excellence, Vidya Herbs Pvt Ltd., Bengaluru, Karnataka, India, Email [email protected]: 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.Keywords: acne vulgaris, inflammation, guggulsterones, ceramide, quality of life