Clinical Trial in Females With Female Pattern Hair Loss

Phase 3

Completed

Lead Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

Brief Summary: 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 uses an objective 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 and for 52 weeks).

This trial will determine if the benefit of using either study product outweighs the risks.

Detailed Description: 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 Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (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 participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 270 to 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 or 2% MTS, for 52 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 regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12, 24, and Week 52 visits TAHC will be evaluated for efficacy analysis.

Recruitment & Eligibility

Inclusion Criteria

females, age 18 or older in general good health
exhibits female pattern hair loss
signs and dates an informed consent document
agrees to use an adequate method of birth control; if of childbearing potential
shows a negative urine pregnancy test at Screening Visit
is willing to maintain the same hair style, hair color, and hair regimen throughout the study
is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria

hypersensitivity to the study product, or any ingredients of the study product
known allergy to hair dye, or hair dye components
clinically relevant history of hypotension
untreated or uncontrolled hypertension
pregnant, planning a pregnancy or nursing a child
history of hair transplants
currently use hair weaves or non-breathable wigs
dermatologic disorders of the scalp that require chronic use of medication for control
other types or history of hair loss
enrolled in any other investigational medication (drug) study currently, or within the last 6 months

Arm && Interventions

Group	Intervention	Description
2% MTS	2% Minoxidil	2% Minoxidil Topical Solution
5% MTF	5% Minoxidil	5% Minoxidil Topical Foam

Primary Outcome Measures

Name	Time	Method
Target Area Hair Count (TAHC)	Baseline to Week 24	Number of hairs in the area being examined as measured by macrophotography.

Secondary Outcome Measures

Name	Time	Method
Target Area Hair Count (TAHC)	Baseline to Week 12	Number of hairs in the area being examined as measured by macrophotography

Locations (12): NW Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Dermatology Research Center, Inc.
🇺🇸
Salt Lake City, Utah, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Centre de Santé Sabouraud
🇫🇷
Paris, Île-de-France, France
Royal Hallamshire Hospital
🇬🇧
Sheffield, South Yorkshire, United Kingdom
Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science
🇩🇪
Berlin, Germany
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Oregon Medical Research Center, P.C.
🇺🇸
Portland,, Oregon, United States
DermResearch, Inc
🇺🇸
Austin, Texas, United States
The Skin Care Centre
🇨🇦
Vancouver, British Columbia, Canada