Androgenetic Alopecia Clinical Trial
Official title:
A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)
This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.
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 participants so that a minimum of 300
female participants with FPHL will be enrolled, to ensure 260 complete. There will be at
least 16 participants enrolled per center at multiple centers located across the US and
globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use
either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.
Participants meeting the inclusion criteria will be randomly assigned in the order of their
enrollment at each site. The signing of the informed consent and assignment of a participant
number to a subject shall constitute enrollment.
During the trial following enrollment at Baseline, participants 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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