Clinical Trial in Females for Female Pattern Hair Loss

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Androgenetic alopecia
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Brief Title

Clinical Trial in Females for Female Pattern Hair Loss

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)

Brief 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.

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Target Area Hair Count

Secondary Outcome

 Target Area Hair Count

Condition

Androgenetic Alopecia

Intervention

5% Minoxidil Topical Foam

Study Arms / Comparison Groups

 Minoxidil Foam
Description:  5% Minoxidil Topical Foam

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

404

Start Date

September 2010

Completion Date

August 2011

Primary Completion Date

August 2011

Eligibility 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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clare Kendall, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT01226459

Organization ID

MINALO3005

Secondary IDs

2010-019881-96

Responsible Party

Sponsor

Study Sponsor

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

Collaborators

 Johnson & Johnson Consumer and Personal Products Worldwide

Study Sponsor

Clare Kendall, Study Director, Johnson & Johnson Consumer and Personal Products Worldwide

Verification Date

June 2014