Clinical trial NCT00151515: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Androgenetic Alopecia
Keywords: Alopecia, Balding
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 352
Sex: MALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings
timeFrame: Baseline to 16 Weeks
Secondary outcomes:
measure: Visual assessment of local dermatitis
timeFrame: Each visit, Baseline through Week 16
measure: Vital Signs
timeFrame: Each visit, Baseline through Week 16
measure: Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs
timeFrame: Baseline vs Week 16
measure: Percent change from baseline in non-vellus hair counts within a specified area of clipped hair
timeFrame: Baseline vs Week 16
measure: Adverse Events
timeFrame: Each visit, Baseline through Week 16
measure: Laboratory Tests (hematology, chemistries, and urinalysis)
timeFrame: at Baseline, Week 8, and Week 16 and Final Visit
measure: Clinical safety assessments, including weight, blood pressure, pulse and adverse events
timeFrame: Every eight weeks, up to one year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Vallejo
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Fridley
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Bruce Kohut, DMD
role: STUDY_DIRECTOR
References: