Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
brief summary
This study is a Phase 3 clinical trial designed to evaluate the efficacy and safety of N1087 compared with placebo in adult men with androgenetic alopecia (male pattern hair loss). The study will include male participants aged 18 to 60 years who have a clinical diagnosis of androgenetic alopecia classified as stages 3V, 4, or 5 on the Norwood-Hamilton scale. Participants will be randomly assigned, in a 2:1 ratio, to receive either N1087 or placebo. Neither the participants nor the study team will know which treatment each participant receives. The study treatment will be taken orally once daily for a total of 24 weeks. During the first 8 weeks, the dose will be gradually increased (titration period) up to a maximum tolerated dose, not exceeding 5 mg. Participants will then continue treatment at the maximum tolerated dose for the remaining 16 weeks. The main purpose of the study is to assess whether oral minoxidil improves hair growth. The primary outcome measure is the change from baseline in the density of non-vellus hairs in a defined target area of the scalp (vertex) after 24 weeks of treatment, measured using digital phototrichogram analysis. Secondary objectives include evaluating changes in hair density at earlier time points, hair thickness, the proportion of terminal hairs, clinical improvement assessed by the investigator, quality of life related to hair loss, and participant satisfaction with treatment. The safety and tolerability of oral minoxidil will also be evaluated by monitoring adverse events, vital signs, and events of special interest throughout the study. An independent Data and Safety Monitoring Committee will oversee participant safety during the trial. This is a multicenter study conducted in Brazil, with approximately 372 participants expected to be enrolled.
official title
A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Male Participants With Androgenetic Alopecia.