A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss

Study Overview
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Brief Summary
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The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.

Detailed Description
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Male subjects with androgenetic alopecia were enrolled in this fourteen-center trial. Subjects were randomized to use either 5% minoxidil or placebo foam twice daily for 16 weeks. A total of 143 subjects continued use of the 5% minoxidil foam for 8 to 12 months in an open-label phase to obtain safety data on 5% minoxidil topical foam when used twice daily for up to one year. 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.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Trial of the Efficacy and Safety of 5 Percent Minoxidil Foam in the Treatment of Androgenetic Alopecia in Males

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: minoxidil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale 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: Known sensitivity to the investigational product

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topical 5% minoxidil foam formulation used twice daily | Drug: minoxidil<br>* Topical 5% minoxidil foam, BID, for sixteen weeks<br>* Other names: Formula # P902942A00 vs Placebo foam (Formula # P902943A00);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings |  | Baseline to 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of local dermatitis |  | Each visit, Baseline through Week 16 | 
| Vital Signs |  | Each visit, Baseline through Week 16 | 
| Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs |  | Baseline vs Week 16 | 
| Percent change from baseline in non-vellus hair counts within a specified area of clipped hair |  | Baseline vs Week 16 | 
| Adverse Events |  | Each visit, Baseline through Week 16 | 
| Laboratory Tests (hematology, chemistries, and urinalysis) |  | at Baseline, Week 8, and Week 16 and Final Visit | 
| Clinical safety assessments, including weight, blood pressure, pulse and adverse events |  | Every eight weeks, up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia, Balding