Clinical Trial in Females With Female Pattern Hair Loss

Completed · Phase 3

Conditions studied: Alopecia

In brief

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.

Key facts

Study ID

NCT01145625

Run by

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

People needed

322

Starts

2010-06-01

Expected to finish

2012-02-01

Last updated by the study team

2014-05-22

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

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Duke University Medical Center — Durham, North Carolina, United States
• NW Dermatology and Research Center — Portland, Oregon, United States
• Oregon Medical Research Center, P.C. — Portland, Oregon, United States
• DermResearch, Inc — Austin, Texas, United States
• Dermatology Research Center, Inc. — Salt Lake City, Utah, United States
• The Skin Care Centre — Vancouver, British Columbia, Canada
• Centre de Santé Sabouraud — Paris, Île-de-France Region, France
• Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science — Berlin, Germany
• Royal Hallamshire Hospital — Sheffield, South Yorkshire, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.