A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
NCT ID: NCT00151515
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
352 participants
INTERVENTIONAL
2003-10-31
2004-07-31
Brief Summary
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Detailed Description
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The 5% minoxidil foam was shown to be effective in the treatment of male androgenetic alopecia in a 16 week trial. It was statistically significantly superior to placebo foam in the primary efficacy measure of mean change in the non-vellus hair count in the target region between Baseline and Week 16, and the subject rating assessed an overall improvement from Baseline.
The efficacy of 5% minoxidil compared to placebo was confirmed by the secondary efficacy endpoints of scores from the expert panel review of hair regrowth when comparing photographs obtained at Baseline with photographs obtained at Week 16, as well as the percent change from Baseline in non-vellus hair counts within a pre-specified area of clipped hair.
The 5% minoxidil foam formulation was well tolerated, the incidence of adverse events was similar between groups, and no safety concerns were raised based on clinical laboratory test results, vital signs or scalp irritation scores.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Topical 5% minoxidil foam formulation used twice daily
minoxidil
Topical 5% minoxidil foam, BID, for sixteen weeks
Interventions
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minoxidil
Topical 5% minoxidil foam, BID, for sixteen weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male sex, age 15 to 49, good health
* Willingness to have a dot tattoo placed in the target area of the scalp during the study
* Willingness to maintain normal shampooing habits and products during the study
* Willingness to maintain the same hair style, approximate length, and hair color throughout the study
Exclusion Criteria
15 Years
49 Years
MALE
Yes
Sponsors
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Johnson & Johnson Consumer and Personal Products Worldwide
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Kohut, DMD
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Vallejo, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Fridley, Minnesota, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Hershey, Pennsylvania, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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A6221001
Identifier Type: -
Identifier Source: org_study_id
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