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This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.
This clinical trial will use a standard measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks).
This trial will determine if the benefit of using either study product outweighs the risks.
This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with FPHL, comparing the new 5% MTF formulation versus the 2% MTS formulation.
This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), 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 270 to 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 or 2% MTS, for 52 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 regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits TAHC will be recorded for primary and secondary outcome analysis.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
5% Minoxidil, 2% Minoxidil
Burke Pharmaceutical Research
Johnson & Johnson Consumer & Personal Products Worldwide
Published on BioPortfolio: 2014-07-23T21:08:45-0400
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