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

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151515
• Other study ID #: A6221001
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: September 28, 2016
• Start date: October 2003
• Est. completion date: July 2004

Study information

• Verified date: September 2016
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• minoxidil
Topical 5% minoxidil foam, BID, for sixteen weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Fridley	Minnesota
United States	Pfizer Investigational Site	Hershey	Pennsylvania
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Visual assessment of local dermatitis		Each visit, Baseline through Week 16	No
Secondary	Vital Signs		Each visit, Baseline through Week 16	No
Secondary	Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs		Baseline vs Week 16	No
Secondary	Percent change from baseline in non-vellus hair counts within a specified area of clipped hair		Baseline vs Week 16	No
Secondary	Adverse Events		Each visit, Baseline through Week 16	No
Secondary	Laboratory Tests (hematology, chemistries, and urinalysis)		at Baseline, Week 8, and Week 16 and Final Visit	No
Secondary	Clinical safety assessments, including weight, blood pressure, pulse and adverse events		Every eight weeks, up to one year	No