Clinical Trial in Females With Female Pattern Hair Loss

NCT ID: NCT01145625

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-02-29

Brief 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.

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.

Conditions

Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

5% MTF

5% Minoxidil Topical Foam

Group Type: EXPERIMENTAL

5% Minoxidil

Intervention Type: DRUG

half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks

2% MTS

2% Minoxidil Topical Solution

Group Type: ACTIVE_COMPARATOR

2% Minoxidil

Intervention Type: DRUG

one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks

Interventions

5% Minoxidil

half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks

Intervention Type: DRUG

2% Minoxidil

one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks

Intervention Type: DRUG

Other Intervention Names

ROGAINE®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clare Kendall, MA

Role: STUDY_DIRECTOR

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

Locations

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

University of Minnesota

Minneapolis, Minnesota, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Duke University Medical Center

Durham, North Carolina, United States

NW Dermatology and Research Center

Portland, Oregon, United States

Oregon Medical Research Center, P.C.

Portland, Oregon, United States

DermResearch, Inc

Austin, Texas, United States

Dermatology Research Center, Inc.

Salt Lake City, Utah, United States

The Skin Care Centre

Vancouver, British Columbia, Canada

Centre de Santé Sabouraud

Paris, Île-de-France Region, France

Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science

Berlin, , Germany

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Countries

United States; Canada; France; Germany; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 27391640 (View on PubMed)

Other Identifiers

2009-018109-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MINALO3004

Identifier Type: -

Identifier Source: org_study_id