Evaluation of the efficacy of topical Nigella sativa L. with vinegar in the treatment of acne vulgaris: A randomized controlled trial

Acne vulgaris stands as the prevailing dermatological condition on a global scale, prompting exploration into diverse therapeutic modalities. Hence, this study aimed to assess the efficacy of a formulation comprising Kalonji (Nigella sativa) and Sirka (vinegar) in comparison to benzoyl peroxide 5 % for the treatment of acne vulgaris. In this open-label randomized controlled trial, 40 participants with acne in the age bracket of 13–40 years completed the 28-day treatment period. The Unani group received a Nigella sativa seed powder and cane vinegar, while the control group received benzoyl peroxide 5 % gel. Both interventions were applied topically at night. Primary outcomes encompassed changes in the Global Acne Grading System (GAGS) and Cook’s Acne Grading Scale using PSAG scores. The secondary outcome was the change in Quality of Life assessed through the Cardiff Acne Disability Index (CADI). Safety evaluations included baseline and post-treatment measurements of hemograms, serum creatinine, serum bilirubin, and random blood sugar levels. The GAGS scores showed a mean difference of −2.600 (95 % CI: −5.770 - 0.570, d=0.57, p = 0.105), PSAG scores exhibited a mean difference of −0.600 (95 % CI: −1.793 - 0.593, d=0.49, p = 0.315), and CADI scores displayed a mean difference of −1.500 (95 % CI: −3.470 - 0.470, d=0.32, p = 0.132) at the trial conclusion. This trial suggests that the formulation may have therapeutic potential as an alternative acne treatment. Further studies with larger sample sizes and extended follow-up periods are recommended. The clinical trial was registered with Clinical Trial Registry – India under the registration number CTRI/2022/05/042368 on May 4, 2022.