Clinical trial NCT01226459: Clinical Trial in Females for Female Pattern Hair Loss
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Androgenetic Alopecia
Keywords: Female Pattern Baldness
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Consumer and Personal Products Worldwide
First posted: 2010-10-22
Enrollment: 404
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target Area Hair Count
timeFrame: Baseline to Week 24
measure: Subject Assessment of Scalp Coverage
timeFrame: Week 24
Secondary outcomes:
measure: Target Area Hair Count
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Wichita
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Glenn Dale
country: United States
facility: Callender Skin & Laser Center
state: Maryland
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of New York
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: David A. Whiting, MD PA
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation Inc
state: Virginia
city: Besançon
country: France
facility: Hôpital Saint Jacques Service de Dermatologie
city: Berlin
country: Germany
facility: Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin
city: Freiburg
country: Germany
facility: Dermaticum Practice for Dermatology
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Clare Kendall
role: STUDY_DIRECTOR
References: