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

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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

Brief 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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


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

Condition

Androgenetic Alopecia

Intervention

minoxidil

Study Arms / Comparison Groups

 1
Description:  Topical 5% minoxidil foam formulation used twice daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

352

Start Date

October 2003

Completion Date

July 2004

Primary Completion Date

July 2004

Eligibility 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
      

Gender

Male

Ages

15 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Bruce Kohut, DMD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00151515

Organization ID

A6221001


Responsible Party

Sponsor

Study Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide


Study Sponsor

Bruce Kohut, DMD, Study Director, Pfizer


Verification Date

September 2016