Status:
COMPLETED
Clinical Trial in Females With Female Pattern Hair Loss
Lead Sponsor:
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Conditions:
Alopecia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 da...
Detailed Description
This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT01145625
Start Date
June 1 2010
End Date
February 1 2012
Last Update
May 22 2014
Active Locations (12)
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1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
4
Duke University Medical Center
Durham, North Carolina, United States, 27710