Clinical Trial in Females for Female Pattern Hair Loss

Phase 3

Completed

Conditions: Androgenetic Alopecia

Interventions: Drug: 5% Minoxidil Topical Foam
Drug: Vehicle Topical Foam

Registration Number: NCT01226459

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

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 404

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minoxidil Foam	5% Minoxidil Topical Foam	5% Minoxidil Topical Foam
Vehicle Foam	Vehicle Topical Foam	Vehicle Topical Foam

Primary Outcome Measures

Name	Time	Method
Target Area Hair Count	Baseline to Week 24	Number of hairs in the area being examined as measured by macrophotography.
Subject Assessment of Scalp Coverage	Week 24	Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.

Secondary Outcome Measures

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

Trial Locations

Locations (16): Axis Clinical Trials
🇺🇸
Los Angeles, California, United States
Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Derm Research Center of New York
🇺🇸
Stony Brook, New York, United States
J&S Studies, Inc.
🇺🇸
College Station, Texas, United States
Callender Skin & Laser Center
🇺🇸
Glenn Dale, Maryland, United States
Hôpital Saint Jacques Service de Dermatologie
🇫🇷
Besançon, France
The Education & Research Foundation Inc
🇺🇸
Lynchburg, Virginia, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
David A. Whiting, MD PA
🇺🇸
Dallas, Texas, United States
Michigan Center for Skin Care Research
🇺🇸
Clinton Township, Michigan, United States
Heartland Research Associates LLC
🇺🇸
Wichita, Kansas, United States
New York University School of Medicine
🇺🇸
New York, New York, United States
Minnesota Clinical Study Center
🇺🇸
Fridley, Minnesota, United States
Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin
🇩🇪
Berlin, Germany
George Eliot Hospital
🇬🇧
Nuneaton, United Kingdom
Dermaticum Practice for Dermatology
🇩🇪
Freiburg, Germany