Therapeutic Evaluation of a Topical Unani Formulation, Tila-i Muhāsā in Buthūr Labaniyya (Acne Vulgaris): A Randomized, Controlled Clinical Study

다국어 초록 (Multilingual Abstract)

Introduction: Buthūr Labaniyya (Acne vulgaris) is a multifactorial disorder of the pilosebaceous units characterized by non-inflammatory and inflammatory clinical lesions. Several Unani medications have been used for centuries to treat acne. Objectives: Evaluation of safety and efficacy of Tila-i Muhāsā in patients with acne vulgaris Materials and Methods: This clinical study was conducted in patients with acne vulgaris. Patients applied Tila-i Muhāsā or 5% Benzoyl Peroxide (BPO) once daily for 6 weeks. Assessment of efficacy was carried out by Global Acne Grading System (GAGS) and Patient Global Assessment (PGA) scores. In addition, overall severity of acne was evaluated on a 5-point Cook's acne grading scale using photographic standards. Assessment of safety was performed through adverse drug reactions, local dermal tolerability, vital signs, and routine laboratory investigations. Results: A total of 60 patients (30 in each group) completed 6 weeks of treatment. The mean percentage reduction in GAGS score at 6 weeks from baseline in Unani group (66.97%) and BPO group (59.09%) was statistically significant (P<0.0001). After 6 weeks of therapy, the mean percentage reduction in PGA score compared to baseline in Unani group (57.44%) and BPO group (50.23%) was statistically significant (P<0.0001). No serious adverse events were reported in both groups; however, mild adverse events occurred more frequently in BPO group (30%) compared to Unani group (10%). Conclusion: Tila-i Muhāsā was found to be effective and safe in the treatment of acne vulgaris. However, further clinical studies with larger sample size and longer duration of therapy need to be conducted.