Phase 3 Completed N=404 Randomized Double-blind Treatment

Clinical Trial in Females for Female Pattern Hair Loss

androgenetic alopecia

Source: ClinicalTrials.gov NCT01226459 ↗

Enrolled (actual)

404

Serious AEs

2.5%

Results posted

Jun 2014

Primary outcomePrimary: Target Area Hair Count — 152.7; 158.6; 162.2; 175.7 hairs per centimeter squared — p=<0.0001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Target Area Hair Count	152.7; 158.6; 163.3; 178.1; 5.4; 16.4	<0.0001 sig
PRIMARY Subject Assessment of Scalp Coverage	0.06; 0.74	<0.0001 sig
SECONDARY Target Area Hair Count	152.7; 158.6; 163.3; 178.1; 5.4; 16.4	<0.0001 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01226459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.