Clinical Trial in Females With Female Pattern Hair Loss
A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5 % Minoxidil Foam vs. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)
2 other identifiers
interventional
322
5 countries
12
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2010
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
April 25, 2014
CompletedMay 22, 2014
May 1, 2014
1.7 years
June 15, 2010
March 26, 2014
May 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Area Hair Count (TAHC)
Number of hairs in the area being examined as measured by macrophotography.
Baseline to Week 24
Secondary Outcomes (1)
Target Area Hair Count (TAHC)
Baseline to Week 12
Other Outcomes (1)
Target Area Hair Count (TAHC)
Baseline to Week 52
Study Arms (2)
5% MTF
EXPERIMENTAL5% Minoxidil Topical Foam
2% MTS
ACTIVE COMPARATOR2% Minoxidil Topical Solution
Interventions
half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
NW Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Medical Research Center, P.C.
Portland, Oregon, 97223, United States
DermResearch, Inc
Austin, Texas, 78759, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124, United States
The Skin Care Centre
Vancouver, British Columbia, V5Z 4E8, Canada
Centre de Santé Sabouraud
Paris, Île-de-France Region, 75010, France
Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science
Berlin, 10117, Germany
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Related Publications (1)
Blume-Peytavi U, Shapiro J, Messenger AG, Hordinsky MK, Zhang P, Quiza C, Doshi U, Olsen EA. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study. J Drugs Dermatol. 2016 Jul 1;15(7):883-9.
PMID: 27391640DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Johnson & Johnson Healthcare Products Division of MCNEIL-PPC, Inc.
Study Officials
- STUDY DIRECTOR
Clare Kendall, MA
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 16, 2010
Study Start
June 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
May 22, 2014
Results First Posted
April 25, 2014
Record last verified: 2014-05