Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss

Phase 2

Completed

• Conditions: Baldness; Alopecia
• Interventions: Drug: bimatoprost Formulation B; Drug: bimatoprost Formulation C; Drug: bimatoprost vehicle solution; Drug: minoxidil 2% solution; Drug: bimatoprost Formulation A

• Registration Number: NCT01325350
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-06
• Primary Completion: 2012-07
• Study Completion: 2012-09
• Disposition First Submitted: 2013-07-31
• Disposition First Submitted QC: 2013-07-31
• Disposition First Posted: 2013-08-07
• Status Verified: 2014-03
• Results First Submitted: 2014-03-03
• Results First Submitted QC: 2014-03-03
• Last Update Submitted: 2014-03-03
• Results First Posted: 2014-04-09
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bimatoprost Formulation B	bimatoprost Formulation B	Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
bimatoprost Formulation C	bimatoprost Formulation C	Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
bimatoprost vehicle solution	bimatoprost vehicle solution	Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
minoxidil 2% solution	minoxidil 2% solution	Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
bimatoprost Formulation A	bimatoprost Formulation A	Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Target Area Hair Count (TAHC)	Baseline, Month 6	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). A negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score	Baseline, Month 6	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

Name	Time	Method
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score	Baseline, Month 6	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	Baseline, Month 6	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)	Baseline, Month 6	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 the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).
Change From Baseline in Target Area Hair Darkness (TAHD)	Baseline, Month 6	Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns) 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).