Clinical Trial in Females for Female Pattern Hair Loss

This study has been completed.
Sponsor:
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. )
ClinicalTrials.gov Identifier:
NCT01226459
First received: October 20, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Androgenetic Alopecia
Drug: 5% Minoxidil Topical Foam
Drug: Vehicle Topical Foam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Target Area Hair Count [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Number of hairs in the area being examined as measured by macrophotography.

  • Subject Assessment of Scalp Coverage [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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:
  • Target Area Hair Count [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Number of hairs in the area being examined as measured by macrophotography.


Enrollment: 404
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226459

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

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier: NCT01226459     History of Changes
Other Study ID Numbers: MINALO3005, 2010-019881-96
Study First Received: October 20, 2010
Results First Received: March 26, 2014
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration
France: Institutional Ethical Committee
Germany: Ethics Commission
United Kingdom: National Health Service

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Female Pattern Baldness

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on August 25, 2014