Clinical Trial in Females for Female Pattern Hair Loss

NCT ID: NCT01226459

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-08-31

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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Minoxidil Foam

5% Minoxidil Topical Foam

Group Type: EXPERIMENTAL

5% Minoxidil Topical Foam

Intervention Type: DRUG

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

Vehicle Foam

Vehicle Topical Foam

Group Type: PLACEBO_COMPARATOR

Vehicle Topical Foam

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Not yet marketed; Vehicle Control (Placebo)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clare Kendall

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer and Personal Products Worldwide

Locations

Axis Clinical Trials

Los Angeles, California, United States

Axis Clinical Trials

Los Angeles, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Heartland Research Associates LLC

Wichita, Kansas, United States

Callender Skin & Laser Center

Glenn Dale, Maryland, United States

Michigan Center for Skin Care Research

Clinton Township, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

New York University School of Medicine

New York, New York, United States

Derm Research Center of New York

Stony Brook, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

J&S Studies, Inc.

College Station, Texas, United States

David A. Whiting, MD PA

Dallas, Texas, United States

The Education & Research Foundation Inc

Lynchburg, Virginia, United States

Hôpital Saint Jacques Service de Dermatologie

Besançon, , France

Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin

Berlin, , Germany

Dermaticum Practice for Dermatology

Freiburg im Breisgau, , Germany

George Eliot Hospital

Nuneaton, , United Kingdom

Countries

United States; France; Germany; United Kingdom

Other Identifiers

2010-019881-96

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MINALO3005

Identifier Type: -

Identifier Source: org_study_id