Status:
COMPLETED
Clinical Trial in Females for Female Pattern Hair Loss
Lead Sponsor:
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Collaborating Sponsors:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Androgenetic Alopecia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 ve...
Detailed Description
This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL)...
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 :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT01226459
Start Date
September 1 2010
End Date
August 1 2011
Last Update
June 10 2014
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Axis Clinical Trials
Los Angeles, California, United States, 90036
2
Axis Clinical Trials
Los Angeles, California, United States, 90057
3
Therapeutics Clinical Research
San Diego, California, United States, 92123
4
Heartland Research Associates LLC
Wichita, Kansas, United States, 67207