Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01325350

Purpose

This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.

Condition	Intervention	Phase
Alopecia Baldness	Drug: bimatoprost Formulation A Drug: bimatoprost Formulation B Drug: bimatoprost Formulation C Drug: bimatoprost vehicle solution Drug: minoxidil 2% solution	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

Drug Information available for: Minoxidil Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change from Baseline in Target Area Hair Count (TAHC) Measured in Terminal Hairs/cm2 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
Subject Self Assessment (SSA) Score Measuring Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator Global Assessment (IGA) Score Measuring Subject Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Global Panel Review (GPR) Score Measuring Subject Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change from Baseline in Target Area Hair Width (TAHW) Measured in um/cm2 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
Change from Baseline in Target Area Hair Darkness (TAHD) Measured in Intensity Units [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	June 2011
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: bimatoprost Formulation A bimatoprost Formulation A	Drug: bimatoprost Formulation A Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Experimental: bimatoprost Formulation B bimatoprost Formulation B	Drug: bimatoprost Formulation B Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Experimental: bimatoprost Formulation C bimatoprost Formulation C	Drug: bimatoprost Formulation C Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Placebo Comparator: bimatoprost vehicle solution bimatoprost vehicle solution	Drug: bimatoprost vehicle solution Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Active Comparator: minoxidil 2% solution minoxidil 2% solution	Drug: minoxidil 2% solution Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months Other Names: Rogaine® Regaine®

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mild to moderate female pattern hair loss with ongoing hair loss for at least 1 year
Willingness to have micro-dot-tattoo applied to scalp
Willingness to maintain same hair style, length and hair color during study

Exclusion Criteria:

Drug or alcohol abuse within 12 months
HIV positive
Received hair transplants or had scalp reductions
Use of hair weaves, hair extensions or wigs within 3 months
Oral or topical minoxidil treatment within 6 months
Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325350

Locations

United States, Oregon

Portland, Oregon, United States
Germany

Berlin, Germany

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01325350 History of Changes
Other Study ID Numbers:	192024-058, 2011-000380-27
Study First Received:	March 28, 2011
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Bimatoprost
Minoxidil
Cloprostenol
Antihypertensive Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012