Phase 3
N=404
Clinical Trial in Females for Female Pattern Hair Loss
Androgenetic Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT01226459 ↗Enrolled (actual)
404
Serious AEs
2.5%
Results posted
Jun 2014
Primary outcome: Primary: Target Area Hair Count — 152.7; 158.6; 162.2; 175.7 hairs per centimeter squared — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 5% Minoxidil Topical Foam (Drug); Vehicle Topical Foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Area Hair Count |
152.7; 158.6; 163.3; 178.1; 5.4; 16.4 | <0.0001 sig |
| PRIMARY Subject Assessment of Scalp Coverage |
0.06; 0.74 | <0.0001 sig |
| SECONDARY Target Area Hair Count |
152.7; 158.6; 163.3; 178.1; 5.4; 16.4 | <0.0001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01226459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.