Bimatoprost for the Treatment of Eyebrow Hypotrichosis

NCT01765764 | Completed Phase 3 Results

• 1 other identifier: 192024-043
• Study Type: interventional
• Target: 357
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Eyebrow Hypotrichosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)

  Baseline, Month 7

• Change From Baseline in Eyebrow Darkness as Measured Using DMSIA

  Baseline, Month 7

• Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6

  Month 7

Study Arms (3)

Bimatoprost Solution BID

EXPERIMENTAL

Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.

Drug: bimatoprost solution

Bimatoprost Solution QD

EXPERIMENTAL

Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.

Drug: bimatoprost solution; Drug: Vehicle to bimatoprost solution

Vehicle to Bimatoprost Solution BID

PLACEBO COMPARATOR

Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.

Drug: Vehicle to bimatoprost solution

Interventions

bimatoprost solution DRUG

Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.

Bimatoprost Solution BID; Bimatoprost Solution QD

Vehicle to bimatoprost solution DRUG

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

Bimatoprost Solution QD; Vehicle to Bimatoprost Solution BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with disease, infection, or abnormality of the eyebrow area
• Patients with permanent eyebrow loss due to over-grooming

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Related 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.

  PMID: 27124878 BACKGROUND

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 10, 2013
• Study Start: March 13, 2013
• Primary Completion: January 31, 2014
• Study Completion: February 11, 2014
• Last Updated: April 23, 2019
• Results First Posted: January 26, 2015

Record last verified: 2019-04

Locations

US (1); CA (1)