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Clinical Trial in Females With 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: NCT01145625
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : April 25, 2014
Last Update Posted : May 22, 2014
Sponsor:
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 June 15, 2010
First Posted Date  ICMJE June 16, 2010
Results First Submitted Date  ICMJE March 26, 2014
Results First Posted Date  ICMJE April 25, 2014
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 24 ]
Number of hairs in the area being examined as measured by macrophotography.
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2010)
Change in TAHC at Week 24 [ Time Frame: Baseline to Week 24 ]
Change in the number of hairs in the area being examined
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 12 ]
Number of hairs in the area being examined as measured by macrophotography
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2010)
Change in TAHC at Week 12 [ Time Frame: Baseline to Week 12 ]
Change in the number of hairs in the area being examined
Current Other Pre-specified Outcome Measures
 (submitted: March 26, 2014)
Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 52 ]
Number of hairs in the area being examined as measured by macrophotography.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial in Females With 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. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)
Brief Summary

This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.

This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).

This trial will determine if the benefit of using either study product outweighs the risks.

Detailed Description

This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (MTS) formulation.

This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), 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 270 to 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 or 2% MTS, for 52 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 regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12, 24, and Week 52 visits TAHC will be evaluated for efficacy analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alopecia
Intervention  ICMJE
  • Drug: 5% Minoxidil
    half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
  • Drug: 2% Minoxidil
    one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
    Other Name: ROGAINE®
Study Arms  ICMJE
  • Experimental: 5% MTF
    5% Minoxidil Topical Foam
    Intervention: Drug: 5% Minoxidil
  • Active Comparator: 2% MTS
    2% Minoxidil Topical Solution
    Intervention: Drug: 2% Minoxidil
Publications * Blume-Peytavi U, Shapiro J, Messenger AG, Hordinsky MK, Zhang P, Quiza C, Doshi U, Olsen EA. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study. J Drugs Dermatol. 2016 Jul 1;15(7):883-9.

*   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: March 26, 2014)
322
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2010)
300
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (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 Canada,   France,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01145625
Other Study ID Numbers  ICMJE MINALO3004
2009-018109-29 ( 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 Not Provided
Investigators  ICMJE
Study Director: Clare Kendall, MA Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date May 2014

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