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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00151515
First received: September 8, 2005
Last updated: October 4, 2011
Last verified: October 2011
  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.


Condition Intervention Phase
Androgenetic Alopecia
Drug: minoxidil
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Enrollment: 352
Study Start Date: October 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Topical 5% minoxidil foam formulation used twice daily
Drug: minoxidil
Topical 5% minoxidil foam, BID, for sixteen weeks
Other Name: Formula # P902942A00 vs Placebo foam (Formula # P902943A00)

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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151515

Locations
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
San Francisco, California, United States, 94102
Pfizer Investigational Site
Vallejo, California, United States, 94503
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80012
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
United States, Minnesota
Pfizer Investigational Site
Fridley, Minnesota, United States, 55421
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55401
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27701
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45202
Pfizer Investigational Site
Cleveland, Ohio, United States, 44101
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97201
United States, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78701
Pfizer Investigational Site
Dallas, Texas, United States, 75201
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84101
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Bruce Kohut, DMD Pfizer
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00151515     History of Changes
Other Study ID Numbers: A6221001
Study First Received: September 8, 2005
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Alopecia, Balding

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases
Minoxidil
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014