Clinical Trial in Females for Female Pattern Hair Loss

Androgenetic Alopecia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226459
• Other study ID #: MINALO3005
• Secondary ID: 2010-019881-96
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2010
• Last updated: June 3, 2014
• Start date: September 2010
• Est. completion date: August 2011

Study information

• Verified date: June 2014
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Institutional Ethical CommitteeGermany: Ethics CommissionUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• 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
• 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

Locations

Country	Name	City	State
France	Hôpital Saint Jacques Service de Dermatologie	Besançon
Germany	Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin	Berlin
Germany	Dermaticum Practice for Dermatology	Freiburg
United Kingdom	George Eliot Hospital	Nuneaton
United States	Cleveland Clinic	Cleveland	Ohio
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	J&S Studies, Inc.	College Station	Texas
United States	David A. Whiting, MD PA	Dallas	Texas
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Callender Skin & Laser Center	Glenn Dale	Maryland
United States	Axis Clinical Trials	Los Angeles	California
United States	Axis Clinical Trials	Los Angeles	California
United States	The Education & Research Foundation Inc	Lynchburg	Virginia
United States	New York University School of Medicine	New York	New York
United States	Therapeutics Clinical Research	San Diego	California
United States	Derm Research Center of New York	Stony Brook	New York
United States	Heartland Research Associates LLC	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.	Johnson & Johnson Consumer and Personal Products Worldwide

Countries where clinical trial is conducted

United States,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Area Hair Count	Number of hairs in the area being examined as measured by macrophotography.	Baseline to Week 24	No
Primary	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	No
Secondary	Target Area Hair Count	Number of hairs in the area being examined as measured by macrophotography.	Baseline to Week 12	No