NCT00151515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

September 8, 2005

Last Update Submit

September 28, 2016

Conditions

Androgenetic Alopecia

Keywords

Alopecia, Balding

Outcome Measures

Primary Outcomes (1)

  • Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings

    Baseline to 16 Weeks

Secondary Outcomes (7)

  • Visual assessment of local dermatitis

    Each visit, Baseline through Week 16

  • Vital Signs

    Each visit, Baseline through Week 16

  • Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs

    Baseline vs Week 16

  • Percent change from baseline in non-vellus hair counts within a specified area of clipped hair

    Baseline vs Week 16

  • Adverse Events

    Each visit, Baseline through Week 16

  • +2 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Topical 5% minoxidil foam formulation used twice daily

Drug: minoxidil

Interventions

minoxidilDRUG

Topical 5% minoxidil foam, BID, for sixteen weeks

Also known as: Formula # P902942A00 vs Placebo foam (Formula # P902943A00)
1

Eligibility Criteria

Age15 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Known sensitivity to the investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Pfizer Investigational Site

La Jolla, California, 92037, United States

Location

Pfizer Investigational Site

San Francisco, California, 94102, United States

Location

Pfizer Investigational Site

Vallejo, California, 94503, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80012, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06510, United States

Location

Pfizer Investigational Site

Fridley, Minnesota, 55421, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55401, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27701, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45202, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44101, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97201, United States

Location

Pfizer Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

Pfizer Investigational Site

Austin, Texas, 78701, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75201, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84101, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Bruce Kohut, DMD

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

October 1, 2003

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

US(15)