Clinical Trial in Females for Female Pattern Hair Loss

NCT01226459 | Completed Phase 3 Results

• 2 other identifiers: MINALO30052010-019881-96
• Study Type: interventional
• Target: 404
• Locations: 4 countries
• Sites: 17

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.

Conditions

Androgenetic Alopecia

Keywords

Female Pattern Baldness

Outcome Measures

Primary Outcomes (2)

• Target Area Hair Count

  Number of hairs in the area being examined as measured by macrophotography.

  Baseline to Week 24

• Subject Assessment of Scalp Coverage

  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.

  Week 24

Secondary Outcomes (1)

• Target Area Hair Count

  Baseline to Week 12

Study Arms (2)

Minoxidil Foam

EXPERIMENTAL

5% Minoxidil Topical Foam

Drug: 5% Minoxidil Topical Foam

Vehicle Foam

PLACEBO COMPARATOR

Vehicle Topical Foam

Drug: Vehicle Topical Foam

Interventions

5% Minoxidil Topical Foam 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

Also known as: Not yet marketed

Minoxidil Foam

Vehicle Topical Foam 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

Also known as: Vehicle Control (Placebo)

Vehicle Foam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.: lead
• Johnson & Johnson Consumer and Personal Products Worldwide: collaborator

Study Sites (17)

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Axis Clinical Trials

Los Angeles, California, 90057, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Heartland Research Associates LLC

Wichita, Kansas, 67207, United States

Location

Callender Skin & Laser Center

Glenn Dale, Maryland, 20769, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Derm Research Center of New York

Stony Brook, New York, 11790, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

David A. Whiting, MD PA

Dallas, Texas, 75246, United States

Location

The Education & Research Foundation Inc

Lynchburg, Virginia, 24501, United States

Location

Hôpital Saint Jacques Service de Dermatologie

Besançon, 25030, France

Location

Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Dermaticum Practice for Dermatology

Freiburg im Breisgau, 79098, Germany

Location

George Eliot Hospital

Nuneaton, CV10 7DJ, United Kingdom

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Johnson & Johnson Healthcare Products Division of MCNEIL-PPC, Inc.

(973) 385-3203

Study Officials

• Clare Kendall

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 22, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 10, 2014
• Results First Posted: June 3, 2014

Record last verified: 2014-06

Locations

FR (1); US (13); DE (2); GB (1)