Clinical Trial in Females With Female Pattern Hair Loss
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| ClinicalTrials.gov Identifier: NCT01145625 |
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Recruitment Status :
Completed
First Posted : June 16, 2010
Results First Posted : April 25, 2014
Last Update Posted : May 22, 2014
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alopecia | Drug: 5% Minoxidil Drug: 2% Minoxidil | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 322 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Study Start Date : | June 2010 |
| Actual Primary Completion Date : | February 2012 |
| Actual Study Completion Date : | February 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 5% MTF
5% Minoxidil Topical Foam
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Drug: 5% Minoxidil
half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks |
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Active Comparator: 2% MTS
2% Minoxidil Topical Solution
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Drug: 2% Minoxidil
one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
Other Name: ROGAINE® |
- Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 24 ]Number of hairs in the area being examined as measured by macrophotography.
- Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 12 ]Number of hairs in the area being examined as measured by macrophotography
- Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 52 ]Number of hairs in the area being examined as measured by macrophotography.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145625
| United States, Arkansas | |
| Burke Pharmaceutical Research | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New Mexico | |
| Academic Dermatology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Oregon | |
| Oregon Medical Research Center, P.C. | |
| Portland,, Oregon, United States, 97223 | |
| NW Dermatology and Research Center | |
| Portland, Oregon, United States, 97210 | |
| United States, Texas | |
| DermResearch, Inc | |
| Austin, Texas, United States, 78759 | |
| United States, Utah | |
| Dermatology Research Center, Inc. | |
| Salt Lake City, Utah, United States, 84124 | |
| Canada, British Columbia | |
| The Skin Care Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E8 | |
| France | |
| Centre de Santé Sabouraud | |
| Paris, Île-de-France, France, 75010 | |
| Germany | |
| Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science | |
| Berlin, Germany, 10117 | |
| United Kingdom | |
| Royal Hallamshire Hospital | |
| Sheffield, South Yorkshire, United Kingdom, S10 2JF | |
| Study Director: | Clare Kendall, MA | Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. |
| Responsible Party: | Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. |
| ClinicalTrials.gov Identifier: | NCT01145625 |
| Other Study ID Numbers: |
MINALO3004 2009-018109-29 ( EudraCT Number ) |
| First Posted: | June 16, 2010 Key Record Dates |
| Results First Posted: | April 25, 2014 |
| Last Update Posted: | May 22, 2014 |
| Last Verified: | May 2014 |
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Female Pattern Baldness |
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Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases |
Pathological Conditions, Anatomical Minoxidil Antihypertensive Agents Vasodilator Agents |