Clinical Trial in Females for Female Pattern Hair Loss

• 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: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• 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: October 20, 2010
• First Posted Date: October 22, 2010
• Results First Submitted Date: March 26, 2014
• Results First Posted Date: June 3, 2014
• Last Update Posted Date: June 10, 2014
• Study Start Date: September 2010
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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)

Current Secondary Outcome Measures (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 (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: Clinical Trial in Females for Female Pattern Hair Loss
• 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)
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Androgenetic Alopecia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 26, 2011): 404
• Original Estimated Enrollment (submitted: October 21, 2010): 300
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, United Kingdom, United States

Administrative Information

• NCT Number: NCT01226459
• Other Study ID Numbers: MINALO3005; 2010-019881-96 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
• Study Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• Collaborators: Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

• Study Director: Clare Kendall; Johnson & Johnson Consumer and Personal Products Worldwide

• PRS Account: Johnson & Johnson Consumer and Personal Products Worldwide
• Verification Date: June 2014