Androgenetic AlopeciaPhase 3NCT01226459
Clinical Trial in Females for Female Pattern Hair Loss
A Phase 3 study testing 5% Minoxidil Topical Foam in people with Androgenetic Alopecia, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. at 17 sites in 4 countries.
Trial summary
This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- 5% Minoxidil Topical Foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Sep 2010to Aug 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females, age 18 or older in general good health
- exhibits female pattern hair loss
- signs and dates an informed consent document
- agrees to use an adequate method of birth control; if of childbearing potential
- shows a negative urine pregnancy test at Screening Visit
- is willing to maintain the same hair style, hair color, and hair regimen throughout the study
- is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
Who cannot join
- hypersensitivity to the (study product), or any ingredients of the (study product)
- known allergy to hair dye, or hair dye components
- clinically relevant history of hypotension
- untreated or uncontrolled hypertension
- pregnant, planning a pregnancy or nursing a child
- history of hair transplants
Show all 10Show fewer
- currently use hair weaves or non-breathable wigs
- dermatologic disorders of the scalp that require chronic use of medication for control
- other types or history of hair loss
- enrolled in any other investigational medication (drug) study currently, or within the last 6 months
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United States13 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
J&S Studies, Inc.
College Station, Texas, 77845
David A. Whiting, MD PA
Dallas, Texas, 75246
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Callender Skin & Laser Center
Glenn Dale, Maryland, 20769
Axis Clinical Trials
Los Angeles, California, 90036
Axis Clinical Trials
Los Angeles, California, 90057
The Education & Research Foundation Inc
Lynchburg, Virginia, 24501
New York University School of Medicine
New York, New York, 10016
Therapeutics Clinical Research
San Diego, California, 92123
Derm Research Center of New York
Stony Brook, New York, 11790
Heartland Research Associates LLC
Wichita, Kansas, 67207
Germany2 sites
Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin
Berlin, 10117
Dermaticum Practice for Dermatology
Freiburg im Breisgau, 79098
About this study
Official title: A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)
This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.
Read the detailed description
This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation.
This clinical trial is designed to compare the risk/benefit profile of the new 5% MTF formulation applied once a day (OD) versus the foam vehicle formulation applied once a day (OD), using objective efficacy measures and safety assessments.
Study centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 260 complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.
Participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment.
During the trial following enrollment at Baseline, participants will return to the study site at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.
- Conditions
- Androgenetic Alopecia
- Being tested
- 5% Minoxidil Topical Foam, Vehicle Topical Foam
- Keywords
- Female Pattern Baldness
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Minoxidil Topical FoamDrug
Also called Not yet marketed
Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks
Vehicle Topical FoamDrug
Also called Vehicle Control (Placebo)
Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil Foam | Experimental | 5% Minoxidil Topical Foam Receives: Drug: 5% Minoxidil Topical Foam |
| Vehicle Foam | Placebo comparator | Vehicle Topical Foam Receives: Drug: Vehicle Topical Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Area Hair Count
Number of hairs in the area being examined as measured by macrophotography.
Measured: Baseline to Week 24
Subject Assessment of Scalp Coverage
Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.
Measured: Week 24
Secondary outcomes (1)
Target Area Hair Count
Number of hairs in the area being examined as measured by macrophotography.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Consumer and Personal Products Worldwide
- Responsible party
- Sponsor
- Investigators
- Clare Kendall, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226459
- Sponsor's protocol ID
- MINALO3005
- Other IDs
- 2010-019881-96
- Status last verified
- Jun 2014
- First submitted
- 20 Oct 2010
- Last updated
- 10 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)
- ClinicalTrials.gov ID
- NCT01226459
- Acronym / sponsor ID
- MINALO3005
- Conditions
- Androgenetic Alopecia
- Keywords
- Female Pattern Baldness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Consumer and Personal Products Worldwide
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.
Detailed description
This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation.
This clinical trial is designed to compare the risk/benefit profile of the new 5% MTF formulation applied once a day (OD) versus the foam vehicle formulation applied once a day (OD), using objective efficacy measures and safety assessments.
Study centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 260 complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.
Participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment.
During the trial following enrollment at Baseline, participants will return to the study site at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minoxidil Foam | Experimental | Drug: 5% Minoxidil Topical Foam5% Minoxidil Topical Foam |
| Vehicle Foam | Placebo comparator | Drug: Vehicle Topical FoamVehicle Topical Foam |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- females, age 18 or older in general good health
- exhibits female pattern hair loss
- signs and dates an informed consent document
- agrees to use an adequate method of birth control; if of childbearing potential
- shows a negative urine pregnancy test at Screening Visit
Key exclusion criteria (10 listed)
- hypersensitivity to the (study product), or any ingredients of the (study product)
- known allergy to hair dye, or hair dye components
- clinically relevant history of hypotension
- untreated or uncontrolled hypertension
- pregnant, planning a pregnancy or nursing a child
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 |
|---|---|---|
| 5% Minoxidil Topical FoamAlso: Not yet marketedDosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks | Drug | Minoxidil Foam |
| Vehicle Topical FoamAlso: Vehicle Control (Placebo)Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks | Drug | Vehicle Foam |
Primary outcome
Target Area Hair Count
Time frame: Baseline to Week 24
Number of hairs in the area being examined as measured by macrophotography.
Subject Assessment of Scalp Coverage
Time frame: Week 24
Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.
1 secondary outcome
Target Area Hair Count
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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.
Clare Kendall study director
Johnson & Johnson Consumer and Personal Products Worldwide
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5% Minoxidil Topical Foam in people with Androgenetic Alopecia, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. at 17 sites in 4 countries.
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 7 inclusion and 10 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 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, France, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Target Area Hair Count (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. 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 10 Jun 2014.