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Clinical Trial in Females for Female Pattern Hair Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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. )

Tracking Information
First Submitted Date  ICMJE October 20, 2010
First Posted Date  ICMJE October 22, 2010
Results First Submitted Date  ICMJE March 26, 2014
Results First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 10, 2014
Study Start Date  ICMJE September 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
  • Target Area Hair Count [ Time Frame: Baseline to Week 24 ]
    Number of hairs in the area being examined as measured by macrophotography.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
Change in Target Area Hair Count [ Time Frame: Baseline to Week 24 ]
Change from baseline in Target Area Hair Count (TAHC)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Target Area Hair Count [ Time Frame: Baseline to Week 12 ]
Number of hairs in the area being examined as measured by macrophotography.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
Change in Target Area Hair Count [ Time Frame: Baseline to Week 12 ]
Change from baseline in Target Area Hair Count (TAHC)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial in Females for Female Pattern Hair Loss
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • 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
  • 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)
Study Arms  ICMJE
  • Experimental: Minoxidil Foam
    5% Minoxidil Topical Foam
    Intervention: Drug: 5% Minoxidil Topical Foam
  • Placebo Comparator: Vehicle Foam
    Vehicle Topical Foam
    Intervention: Drug: Vehicle Topical Foam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2011)
404
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2010)
300
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01226459
Other Study ID Numbers  ICMJE MINALO3005
2010-019881-96 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
Study Sponsor  ICMJE Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Collaborators  ICMJE Johnson & Johnson Consumer and Personal Products Worldwide
Investigators  ICMJE
Study Director: Clare Kendall Johnson & Johnson Consumer and Personal Products Worldwide
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP