The effective dose of botulinum toxin A for acne management: a randomized controlled trial

Abstract

Botulinum toxin A (BTX-A) has been studied for its ability to reduce sebum production and inflammation, both of which are involved in acne pathogenesis. However, there is a lack of data regarding the use of BTX-A in acne treatment. This study aimed to investigate the efficacy and safety of different doses of BTX-A in the treatment of acne vulgaris, enlarged facial pores, and skin oiliness. In this randomized, double-blinded, placebo-controlled trial, 75 patients with moderate acne vulgaris were assigned to receive a single injection of either 6 units (1:5 dilution), 12 units (1:2.5 dilution) of BTX-A, or a placebo into their forehead. The treatment effectiveness was evaluated at 2, 4, 8, 12, and 16 weeks post-injection, focusing on the improvements in acne vulgaris severity, pore size, and forehead oiliness. Subjects receiving either 6 or 12 units of BTX-A showed a significant reduction in the total acne lesion count, Global Acne Severity Scale, sebum level, and pore volume at weeks 2 to 16 post-injection, with effects lasting up to 16 weeks in both groups. The results did not differ significantly between the 6-unit and 12-unit therapy groups, except for sebum level that more decreased in the 12-unit BTX-A. BTX-A injection is safe and effective for treating acne vulgaris and reducing enlarged pores and oiliness. Both lower and standard dosage of BTX-A have similar efficacy in the treatment of acne. Clinical Trial Registration: Thai Clinical Trials Registry (TCTR20231025002).