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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

September 8, 2005
October 4, 2011
October 2003
July 2004   (final data collection date for 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00151515 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Androgenetic Alopecia
Drug: minoxidil
Topical 5% minoxidil foam, BID, for sixteen weeks
Other Name: Formula # P902942A00 vs Placebo foam (Formula # P902943A00)
Experimental: 1
Topical 5% minoxidil foam formulation used twice daily
Intervention: Drug: minoxidil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
352
July 2004
July 2004   (final data collection date for primary outcome measure)

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
Male
15 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00151515
A6221001
No
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
Study Director: Bruce Kohut, DMD Pfizer
Johnson & Johnson Consumer and Personal Products Worldwide
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP