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

• ClinicalTrials.gov Identifier: NCT00151515
• Recruitment Status: Completed
• First Posted: September 9, 2005
• Last Update Posted: September 30, 2016
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Androgenetic Alopecia	Drug: minoxidil	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 352 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: October 2003
• Actual Primary Completion Date: July 2004
• Actual Study Completion Date: July 2004

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Visual assessment of local dermatitis [ Time Frame: Each visit, Baseline through Week 16 ]
2. Vital Signs [ Time Frame: Each visit, Baseline through Week 16 ]
3. Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs [ Time Frame: Baseline vs Week 16 ]
4. Percent change from baseline in non-vellus hair counts within a specified area of clipped hair [ Time Frame: Baseline vs Week 16 ]
5. Adverse Events [ Time Frame: Each visit, Baseline through Week 16 ]
6. Laboratory Tests (hematology, chemistries, and urinalysis) [ Time Frame: at Baseline, Week 8, and Week 16 and Final Visit ]
7. Clinical safety assessments, including weight, blood pressure, pulse and adverse events [ Time Frame: Every eight weeks, up to one year ]

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 49 Years (Child, Adult)
• Sexes 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

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

• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
• ClinicalTrials.gov Identifier: NCT00151515
• Other Study ID Numbers: A6221001
• First Posted: September 9, 2005
• Last Update Posted: September 30, 2016
• Last Verified: September 2016

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Alopecia, Balding

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Minoxidil; Antihypertensive Agents; Vasodilator Agents