Clinical Trial in Females With Female Pattern Hair Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier:
NCT01145625
First received: June 15, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Alopecia
Drug: 5% Minoxidil
Drug: 2% Minoxidil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Number of hairs in the area being examined as measured by macrophotography.


Secondary Outcome Measures:
  • Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Number of hairs in the area being examined as measured by macrophotography


Other Outcome Measures:
  • Target Area Hair Count (TAHC) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Number of hairs in the area being examined as measured by macrophotography.


Enrollment: 322
Study Start Date: June 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5% MTF
5% Minoxidil Topical Foam
Drug: 5% Minoxidil
half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
Active Comparator: 2% MTS
2% Minoxidil Topical Solution
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145625

Locations
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
NW Dermatology and Research Center
Portland, Oregon, United States, 97210
Oregon Medical Research Center, P.C.
Portland,, Oregon, United States, 97223
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
Sponsors and Collaborators
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Investigators
Study Director: Clare Kendall, MA Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier: NCT01145625     History of Changes
Other Study ID Numbers: MINALO3004, 2009-018109-29
Study First Received: June 15, 2010
Results First Received: March 26, 2014
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
United Kingdom: National Health Service

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Female Pattern Baldness

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on July 28, 2014