Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

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.

Study Overview

• Status: Completed
• Conditions: Alopecia; Alopecia, Androgenetic; Baldness
• Intervention / Treatment: Drug: bimatoprost Formulation A; Drug: bimatoprost Formulation B; Drug: bimatoprost Formulation C; Drug: bimatoprost vehicle solution; Drug: minoxidil 5% solution

• Study Type: Interventional
• Enrollment (Actual): 307
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
• United States
  • Oregon
    • Portland, Oregon, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Regaine®; Rogaine®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Target Area Hair Count (TAHC)	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).	Baseline, Month 6
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score	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.	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score	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.	Baseline, Month 6
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score	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.	Baseline, Month 6
Change From Baseline in Target Area Hair Width (TAHW)	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).	Baseline, Month 6
Change From Baseline in Target Area Hair Darkness (TAHD)	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).	Baseline, Month 6

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Estimate): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Pharmaceutical Solutions; Bimatoprost; Minoxidil
• Other Study ID Numbers: 192024-057; 2011-000379-15 (EudraCT Number)