Clinical trial NCT01145625: Clinical Trial in Females With 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. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia
Keywords: Female Pattern Baldness
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 322
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Target Area Hair Count (TAHC)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Target Area Hair Count (TAHC)
timeFrame: Baseline to Week 12
Other outcomes:
measure: Target Area Hair Count (TAHC)
timeFrame: Baseline to Week 52
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland,
country: United States
facility: Oregon Medical Research Center, P.C.
state: Oregon
city: Portland
country: United States
facility: NW Dermatology and Research Center
state: Oregon
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Vancouver
country: Canada
facility: The Skin Care Centre
state: British Columbia
city: Paris
country: France
facility: Centre de Santé Sabouraud
state: Île-de-France
city: Berlin
country: Germany
facility: Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
name: Clare Kendall, MA
role: STUDY_DIRECTOR
References:
citation: 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.