Clinical Trial in Females With Female Pattern Hair Loss
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5 % Minoxidil Foam vs. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)|
- Change in TAHC at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]Change in the number of hairs in the area being examined
- Change in TAHC at Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]Change in the number of hairs in the area being examined
|Study Start Date:||June 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: 5% MTF
5% Minoxidil Topical Foam
Drug: 5% Minoxidil
half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
Active Comparator: 2% MTS
2% Minoxidil Topical Solution
Drug: 2% Minoxidil
one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
Other Name: ROGAINE®
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.
|United States, Arkansas|
|Burke Pharmaceutical Research|
|Hot Springs, Arkansas, United States, 71913|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New Mexico|
|Academic Dermatology Associates|
|Albuquerque, New Mexico, United States, 87106|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Oregon|
|NW Dermatology and Research Center|
|Portland, Oregon, United States, 97210|
|Oregon Medical Research Center, P.C.|
|Portland,, Oregon, United States, 97223|
|United States, Texas|
|Austin, Texas, United States, 78759|
|United States, Utah|
|Dermatology Research Center, Inc.|
|Salt Lake City, Utah, United States, 84124|
|Canada, British Columbia|
|The Skin Care Centre|
|Vancouver, British Columbia, Canada, V5Z 4E8|
|Centre de Santé Sabouraud|
|Paris, Île-de-France, France, 75010|
|Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science|
|Berlin, Germany, 10117|
|Royal Hallamshire Hospital|
|Sheffield, South Yorkshire, United Kingdom, S10 2JF|
|Study Director:||Clare Kendall, MA||Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.|