Clinical Trial in Females for Female Pattern Hair Loss

• Change in Target Area Hair Count [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  Change from baseline in Target Area Hair Count (TAHC)
  
  

• Change in Target Area Hair Count [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  Change from baseline in Target Area Hair Count (TAHC)
  
  

This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation.

This clinical trial is designed to compare the risk/benefit profile of the new 5% MTF formulation applied once a day (OD) versus the foam vehicle formulation applied once a day (OD), using objective efficacy measures and safety assessments.

Study centers will screen a sufficient number of subjects so that a minimum of 300 female subjects with FPHL will be enrolled, to ensure 260 complete. There will be at least 16 subjects enrolled per center at multiple centers located across the US and globally. Approximately 300 subjects will be randomized in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.

Subjects meeting the inclusion criteria will be randomized in the order of their enrollment at each site. The signing of the informed consent and assignment of a subject number to a subject shall constitute enrollment.

During the trial following enrollment at Baseline, subjects will return to the study site at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.