Clinical Trial in Females With Female Pattern Hair Loss

Alopecia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145625
• Other study ID #: MINALO3004
• Secondary ID: 2009-018109-29
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2010
• Last updated: May 19, 2014
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: May 2014
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Ethics Review CommitteeFrance: Institutional Ethical CommitteeGermany: Ethics CommissionUnited Kingdom: National Health Service
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• 5% Minoxidil
half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
• 2% Minoxidil
one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks

Locations

Country	Name	City	State
Canada	The Skin Care Centre	Vancouver	British Columbia
France	Centre de Santé Sabouraud	Paris	Île-de-France
Germany	Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science	Berlin
United Kingdom	Royal Hallamshire Hospital	Sheffield	South Yorkshire
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc	Austin	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	University of Minnesota	Minneapolis	Minnesota
United States	NW Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center, P.C.	Portland,	Oregon
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Target Area Hair Count (TAHC)	Number of hairs in the area being examined as measured by macrophotography.	Baseline to Week 52	No
Primary	Target Area Hair Count (TAHC)	Number of hairs in the area being examined as measured by macrophotography.	Baseline to Week 24	No
Secondary	Target Area Hair Count (TAHC)	Number of hairs in the area being examined as measured by macrophotography	Baseline to Week 12	No