Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia - Full Text View

Purpose

This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.

Condition	Intervention	Phase
Alopecia Alopecia, Androgenetic Baldness	Drug: bimatoprost Formulation A Drug: bimatoprost Formulation B Drug: bimatoprost Formulation C Drug: bimatoprost vehicle solution Drug: minoxidil 5% 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

Genetic and Rare Diseases Information Center resources: Congenital Alopecia X-linked

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change From Baseline in Target Area Hair Count (TAHC) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Secondary Outcome Measures:

Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Change From Baseline in Target Area Hair Width (TAHW) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).
Change From Baseline in Target Area Hair Darkness (TAHD) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).


Enrollment:	307
Study Start Date:	June 2011
Study Completion Date:	September 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: bimatoprost Formulation A Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.	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 Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.	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 Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.	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 Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.	Drug: bimatoprost vehicle solution Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Active Comparator: minoxidil 5% solution Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.	Drug: minoxidil 5% 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 49 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mild to moderate male pattern baldness (androgenic alopecia) 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325337

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:	NCT01325337 History of Changes
Other Study ID Numbers:	192024-057, 2011-000379-15
Study First Received:	March 28, 2011
Results First Received:	March 3, 2014
Last Updated:	April 8, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Alopecia Alopecia Areata Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Skin Diseases Bimatoprost Cloprostenol Pharmaceutical Solutions	Antihypertensive Agents Cardiovascular Agents Contraceptive Agents Contraceptive Agents, Female Luteolytic Agents Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015