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

Condition(s) targeted: Androgenetic Alopecia

Intervention: minoxidil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Consumer & Personal Products Worldwide

Official(s) and/or principal investigator(s):
Bruce Kohut, DMD, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings

Secondary outcome:

Visual assessment of local dermatitis

Vital Signs

Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs

Percent change from baseline in non-vellus hair counts within a specified area of clipped hair

Adverse Events

Laboratory Tests (hematology, chemistries, and urinalysis)

Clinical safety assessments, including weight, blood pressure, pulse and adverse events

Detailed 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.

Minimum age: 15 Years. Maximum age: 49 Years. Gender(s): Male.

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

Pfizer Investigational Site, Vallejo, California 94503, United States

Pfizer Investigational Site, La Jolla, California 92037, United States

Pfizer Investigational Site, San Francisco, California 94102, United States

Pfizer Investigational Site, Denver, Colorado 80012, United States

Pfizer Investigational Site, New Haven, Connecticut 06510, United States

Pfizer Investigational Site, Minneapolis, Minnesota 55401, United States

Pfizer Investigational Site, Fridley, Minnesota 55421, United States

Pfizer Investigational Site, Durham, North Carolina 27701, United States

Pfizer Investigational Site, Cleveland, Ohio 44101, United States

Pfizer Investigational Site, Cincinnati, Ohio 45202, United States

Pfizer Investigational Site, Portland, Oregon 97201, United States

Pfizer Investigational Site, Hershey, Pennsylvania 17033, United States

Pfizer Investigational Site, Austin, Texas 78701, United States

Pfizer Investigational Site, Dallas, Texas 75201, United States

Pfizer Investigational Site, Salt Lake City, Utah 84101, United States

Starting date: October 2003
Ending date: July 2004
Last updated: March 27, 2008