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

Alopecia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325337
• Other study ID #: 192024-057
• Secondary ID: 2011-000379-15
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2011
• Last updated: April 8, 2014
• Start date: June 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia, Androgenetic
• Baldness

Intervention

Drug:
• bimatoprost Formulation A
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
• bimatoprost Formulation B
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
• bimatoprost Formulation C
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
• bimatoprost vehicle solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
• minoxidil 5% solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No