Safety and Efficacy of Actinic Keratoses Reduction with a 3-Day Application of Ingenol Disoxate Field Treatment to the Face, Chest, and Balding Scalp

The document summarizes a phase 2 clinical trial that assessed the safety and effectiveness of SM04554, a topical treatment for male androgenetic alopecia (AGA). The trial involved 49 male participants with moderate hair loss, who applied either 0.15%, 0.25% SM04554, or a placebo daily for 90 days. Safety was monitored over 142 days, and scalp biopsies were taken to measure hair follicle counts and growth phases. The findings indicated that the 0.25% dosage resulted in a significant increase in total hair follicle counts at Days 91 and 135, while the 0.15% dosage showed a significant increase at Day 135, with no serious adverse events reported. The study, funded by Samumed LLC, suggested that SM04554 has the potential to induce hair growth and could be an effective treatment for AGA.