Clinical Trial in Females for Female Pattern Hair Loss

Completed · Phase 3 · Has a placebo group

Conditions studied: Androgenetic Alopecia

In brief

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.

Key facts

Study ID

NCT01226459

Run by

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

People needed

404

Starts

2010-09-01

Expected to finish

2011-08-01

Last updated by the study team

2014-06-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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