Clinical Trial in Females With Female Pattern Hair Loss

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• 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