Clinical Trial in Females for Female Pattern Hair Loss

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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