Bimatoprost for the Treatment of Eyebrow Hypotrichosis

Eyebrow Hypotrichosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765764
• Other study ID #: 192024-043
• Status: Completed
• Phase: Phase 3
• Start date: March 13, 2013
• Est. completion date: February 11, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: February 11, 2014
• Est. primary completion date: January 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).

Exclusion Criteria:

• Patients with disease, infection, or abnormality of the eyebrow area

• Patients with permanent eyebrow loss due to over-grooming

Related Conditions & MeSH terms

• Eyebrow Hypotrichosis
• Hypotrichosis

Intervention

Drug:
• bimatoprost solution
Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
• Vehicle to bimatoprost solution
Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Carruthers J, Beer K, Carruthers A, Coleman WP 3rd, Draelos ZD, Jones D, Goldman MP, Pucci ML, VanDenburgh A, Weng E, Whitcup SM. Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis. Dermatol Surg. 2016 May;42(5):608-17. doi: 10.1097/DSS.0000000000000755. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale	The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.	Baseline, Month 7
Secondary	Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)	Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).	Baseline, Month 7
Secondary	Change From Baseline in Eyebrow Darkness as Measured Using DMSIA	Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).	Baseline, Month 7
Secondary	Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6	ESS Item #6 measured the participant's satisfaction with eyebrow treatment: "Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now?" using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported.	Month 7