AlopeciaPhase 3NCT01145625
Clinical Trial in Females With Female Pattern Hair Loss
A Phase 3 study testing 5% Minoxidil and 2% Minoxidil in people with Alopecia, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. at 12 sites in 5 countries.
Trial summary
This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alopecia
- What is being tested?
- 5% Minoxidil and 2% Minoxidil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Jun 2010to Feb 2012
- 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
12 sites in 5 countries.
12 sites in 5 countries
United States8 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc
Austin, Texas, 78759
Duke University Medical Center
Durham, North Carolina, 27710
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
University of Minnesota
Minneapolis, Minnesota, 55455
NW Dermatology and Research Center
Portland, Oregon, 97210
Oregon Medical Research Center, P.C.
Portland, Oregon, 97223
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
Germany1 site
Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science
Berlin, 10117
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
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. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)
This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.
This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).
This trial will determine if the benefit of using either study product outweighs the risks.
Read the detailed description
This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (MTS) formulation.
This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), 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 270 to 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 or 2% MTS, for 52 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 regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12, 24, and Week 52 visits TAHC will be evaluated for efficacy analysis.
- Conditions
- Alopecia
- Being tested
- 5% Minoxidil, 2% Minoxidil
- 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% MinoxidilDrug
half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
2% MinoxidilDrug
Also called ROGAINE®
one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 5% MTF | Experimental | 5% Minoxidil Topical Foam Receives: Drug: 5% Minoxidil |
| 2% MTS | Active comparator | 2% Minoxidil Topical Solution Receives: Drug: 2% Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Area Hair Count (TAHC)
Number of hairs in the area being examined as measured by macrophotography.
Measured: Baseline to Week 24
Secondary outcomes (1)
Target Area Hair Count (TAHC)
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 posted16 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2012
- Study completionFeb 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clare Kendall, MA, Study director, Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145625
- Sponsor's protocol ID
- MINALO3004
- Other IDs
- 2009-018109-29, 2009
- Status last verified
- May 2014
- First submitted
- 15 Jun 2010
- Last updated
- 22 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Blume-Peytavi U, Shapiro J, Messenger AG, Hordinsky MK, Zhang P, Quiza C, Doshi U, Olsen EA. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study. J Drugs Dermatol. 2016 Jul 1;15(7):883-9.
PubMed 27391640
Study at a glance
From the registry record, last updated by the sponsor on 22 May 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. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)
- ClinicalTrials.gov ID
- NCT01145625
- Acronym / sponsor ID
- MINALO3004
- Conditions
- Alopecia
- Keywords
- Female Pattern Baldness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Posted 25 Apr 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 year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.
This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).
This trial will determine if the benefit of using either study product outweighs the risks.
Detailed description
This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (MTS) formulation.
This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), 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 270 to 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 or 2% MTS, for 52 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 regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12, 24, and Week 52 visits TAHC will be evaluated for efficacy analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% MTF | Experimental | Drug: 5% Minoxidil5% Minoxidil Topical Foam |
| 2% MTS | Active comparator | Drug: 2% Minoxidil2% Minoxidil Topical Solution |
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% Minoxidilhalf a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks | Drug | 5% MTF |
| 2% MinoxidilAlso: ROGAINE®one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks | Drug | 2% MTS |
Primary outcome
Target Area Hair Count (TAHC)
Time frame: Baseline to Week 24
Number of hairs in the area being examined as measured by macrophotography.
1 secondary outcome
Target Area Hair Count (TAHC)
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 22 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27391640Blume-Peytavi U, Shapiro J, Messenger AG, Hordinsky MK, Zhang P, Quiza C, Doshi U, Olsen EA. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study. J Drugs Dermatol. 2016 Jul 1;15(7):883-9.
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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.
Clare Kendall, MA study director
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5% Minoxidil and 2% Minoxidil in people with Alopecia, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. at 12 sites in 5 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, France, Germany, 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. 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 25 Apr 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 (TAHC) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01145625, which also lists 1 linked publication.
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 22 May 2014.