A Phase 3 interventional study of minoxidil in Androgenetic Alopecia, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide. Completed at 15 sites in United States. Open to male participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-30.
Sponsored by Johnson & Johnson Consumer and Personal Products Worldwide · Phase 3, Interventional, and Treatment
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.
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.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 352 is above the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Johnson & Johnson Consumer and Personal Products Worldwide is the lead sponsor of 58 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topical 5% minoxidil foam formulation used twice daily
Drug: minoxidil
Topical 5% minoxidil foam, BID, for sixteen weeks
Also known as: Formula # P902942A00 vs Placebo foam (Formula # P902943A00)
Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings
Time frame: Baseline to 16 Weeks
Visual assessment of local dermatitis
Time frame: Each visit, Baseline through Week 16
Vital Signs
Time frame: Each visit, Baseline through Week 16
Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs
Time frame: Baseline vs Week 16
Percent change from baseline in non-vellus hair counts within a specified area of clipped hair
Time frame: Baseline vs Week 16
Adverse Events
Time frame: Each visit, Baseline through Week 16
Laboratory Tests (hematology, chemistries, and urinalysis)
Time frame: at Baseline, Week 8, and Week 16 and Final Visit
Clinical safety assessments, including weight, blood pressure, pulse and adverse events
Time frame: Every eight weeks, up to one year
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer and Personal Products Worldwide