Clinical Trial in Females for Female Pattern Hair Loss

• ClinicalTrials.gov Identifier: NCT01226459
• Recruitment Status: Completed
• First Posted: October 22, 2010
• Results First Posted: June 3, 2014
• Last Update Posted: June 10, 2014
• Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• Collaborator: Johnson & Johnson Consumer and Personal Products Worldwide
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Androgenetic Alopecia	Drug: 5% Minoxidil Topical Foam; Drug: Vehicle Topical Foam	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 404 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)
• Study Start Date: September 2010
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Minoxidil Foam; 5% Minoxidil Topical Foam	Drug: 5% Minoxidil Topical Foam; Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks; Other Name: Not yet marketed
Placebo Comparator: Vehicle Foam; Vehicle Topical Foam	Drug: Vehicle Topical Foam; Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks; Other Name: Vehicle Control (Placebo)

Outcome Measures

Primary Outcome Measures :

1. Target Area Hair Count [ Time Frame: Baseline to Week 24 ]
   Number of hairs in the area being examined as measured by macrophotography.
2. Subject Assessment of Scalp Coverage [ Time Frame: 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 :

1. Target Area Hair Count [ Time Frame: Baseline to Week 12 ]
   Number of hairs in the area being examined as measured by macrophotography.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Axis Clinical Trials

Los Angeles, California, United States, 90036

Axis Clinical Trials

Los Angeles, California, United States, 90057

Therapeutics Clinical Research

San Diego, California, United States, 92123

United States, Kansas

Heartland Research Associates LLC

Wichita, Kansas, United States, 67207

United States, Maryland

Callender Skin & Laser Center

Glenn Dale, Maryland, United States, 20769

United States, Michigan

Michigan Center for Skin Care Research

Clinton Township, Michigan, United States, 48038

United States, Minnesota

Minnesota Clinical Study Center

Fridley, Minnesota, United States, 55432

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

Derm Research Center of New York

Stony Brook, New York, United States, 11790

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Texas

J&S Studies, Inc.

College Station, Texas, United States, 77845

David A. Whiting, MD PA

Dallas, Texas, United States, 75246

United States, Virginia

The Education & Research Foundation Inc

Lynchburg, Virginia, United States, 24501

France

Hôpital Saint Jacques Service de Dermatologie

Besançon, France, 25030

Germany

Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin

Berlin, Germany, 10117

Dermaticum Practice for Dermatology

Freiburg, Germany, 79098

United Kingdom

George Eliot Hospital

Nuneaton, United Kingdom, CV10 7DJ

Sponsors and Collaborators

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

Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

• Study Director: Clare Kendall; Johnson & Johnson Consumer and Personal Products Worldwide

More Information

• Responsible Party: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• ClinicalTrials.gov Identifier: NCT01226459
• Other Study ID Numbers: MINALO3005; 2010-019881-96 ( EudraCT Number )
• First Posted: October 22, 2010
• Results First Posted: June 3, 2014
• Last Update Posted: June 10, 2014
• Last Verified: June 2014

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. ):

Female Pattern Baldness

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Minoxidil; Antihypertensive Agents; Vasodilator Agents