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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


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
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