Therapeutic evaluation of herbal formulation in acne vulgaris and its influence on quality of life—A single-arm clinical trial

Introduction
Acne vulgaris is a disease of the pilosebaceous unit that primarily affects teenagers and young adults. It relates to significant psychological morbidity and, on rare occasions, fatality due to suicidal tendencies. Though Unani medicines have been used to treat it for millennia, scientific investigations and evidence-based literature are rare. Thus, the purpose of this study was to determine the efficacy of the herbal formulation Ṭilā-i Muhāsa consisting of Azadirachta indica A. Juss., Albizia lebbeck L., and Iris ensata Thunb. in treating acne vulgaris as well as the influence on patients’ quality of life.

Methods
In this clinical trial, 31 clinically diagnosed patients with acne vulgaris received Ṭilā-i Muhāsa to be applied on the afflicted site every night and washed off with normal water after 20–30 min, of whom 30 completed the protocol therapy. The primary outcome measures were changes in subjective parameters such as comedones, papules, pustules, erythema, and itching, assessed on a 4-point grading scale, and change in investigator’s global assessment (IGA) for overall disease severity, at baseline, 7th, 14th, and 21st days. The secondary outcome measure was change in quality of life (QoL), assessed on the Cardiff acne disability index (CADI).

Results
The per-protocol analysis of subjective parameters revealed statistically significant improvement in comedones, papules, pustules, erythema, nodules, and itching. Additionally, statistically significant improvements in IGA and QoL were also detected.

Conclusion
The findings of the present study indicated that topical use of Ṭilā-i Muhāsa is an effective and well-tolerated therapeutic option for patients with moderate to severe acne vulgaris.