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Fridley, Minnesota 55421

  • Androgenetic Alopecia

Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

A6221001


NCT ID:

NCT00151515


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Male


Minimum Age:

15 Years


Maximum Age:

49 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johnson & Johnson Consumer and Personal Products Worldwide


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

352


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bruce Kohut, DMD
Study Director
Pfizer

Study Dates

Start Date:October 2003
Completion Date:July 2004
Completion Type:Actual
Primary Completion Date:July 2004
Primary Completion Type:Actual
Verification Date:September 2016
Last Changed Date:September 28, 2016
First Received Date:September 8, 2005

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:minoxidil
Description:Topical 5% minoxidil foam, BID, for sixteen weeks
Arm Name:1
Other Name:Formula # P902942A00 vs Placebo foam (Formula # P9

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Topical 5% minoxidil foam formulation used twice daily

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Johnson & Johnson Consumer and Personal Products Worldwide

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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