Androgenetic AlopeciaPhase 3NCT00151515
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
A Phase 3 study testing minoxidil in people with Androgenetic Alopecia, run by Johnson & Johnson Consumer and Personal Products Worldwide at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- minoxidil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2003to Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Known sensitivity to the investigational product
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Pfizer Investigational Site
Austin, Texas, 78701
Pfizer Investigational Site
Cincinnati, Ohio, 45202
Pfizer Investigational Site
Cleveland, Ohio, 44101
Pfizer Investigational Site
Dallas, Texas, 75201
Pfizer Investigational Site
Denver, Colorado, 80012
Pfizer Investigational Site
Durham, North Carolina, 27701
Pfizer Investigational Site
Fridley, Minnesota, 55421
Pfizer Investigational Site
Hershey, Pennsylvania, 17033
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Minneapolis, Minnesota, 55401
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
Portland, Oregon, 97201
Pfizer Investigational Site
Salt Lake City, Utah, 84101
Pfizer Investigational Site
San Francisco, California, 94102
Pfizer Investigational Site
Vallejo, California, 94503
About this study
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
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.
Read the 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- minoxidil
- Keywords
- Alopecia, Balding
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minoxidilDrug
Also called Formula # P902942A00 vs Placebo foam (Formula # P902943A00)
Topical 5% minoxidil foam, BID, for sixteen weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Topical 5% minoxidil foam formulation used twice daily Receives: Drug: minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings
Measured: Baseline to 16 Weeks
Secondary outcomes (7)
Visual assessment of local dermatitis
Measured: Each visit, Baseline through Week 16
Vital Signs
Measured: Each visit, Baseline through Week 16
Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs
Measured: Baseline vs Week 16
Percent change from baseline in non-vellus hair counts within a specified area of clipped hair
Measured: Baseline vs Week 16
Adverse Events
Measured: Each visit, Baseline through Week 16
Laboratory Tests (hematology, chemistries, and urinalysis)
Measured: at Baseline, Week 8, and Week 16 and Final Visit
Clinical safety assessments, including weight, blood pressure, pulse and adverse events
Measured: Every eight weeks, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Kohut, DMD, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151515
- Sponsor's protocol ID
- A6221001
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2005
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00151515
- Acronym / sponsor ID
- A6221001
- Conditions
- Androgenetic Alopecia
- Keywords
- Alopecia, Balding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: minoxidilTopical 5% minoxidil foam formulation used twice daily |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Known sensitivity to the investigational product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minoxidilAlso: Formula # P902942A00 vs Placebo foam (Formula # P902943A00)Topical 5% minoxidil foam, BID, for sixteen weeks | Drug | 1 |
Primary outcome
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
7 secondary outcomes
Visual assessment of local dermatitis
Time frame: Each visit, Baseline through Week 16
Vital Signs
Time frame: Each visit, Baseline through Week 16
Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs
Time frame: Baseline vs Week 16
Percent change from baseline in non-vellus hair counts within a specified area of clipped hair
Time frame: Baseline vs Week 16
Adverse Events
Time frame: Each visit, Baseline through Week 16
Laboratory Tests (hematology, chemistries, and urinalysis)
Time frame: at Baseline, Week 8, and Week 16 and Final Visit
Clinical safety assessments, including weight, blood pressure, pulse and adverse events
Time frame: Every eight weeks, up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Kohut, DMD study director
Pfizer
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing minoxidil in people with Androgenetic Alopecia, run by Johnson & Johnson Consumer and Personal Products Worldwide at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.