Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis

NCT01391286 | Completed Phase 3 Results

• 1 other identifier: 192024-067
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.

Conditions

Eyelash Hypotrichosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)

  The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.

  Baseline, Month 4

Secondary Outcomes (3)

• Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)

  Baseline, Month 4

• Change From Baseline in Eyelash Thickness as Measured by DIA

  Baseline, Month 4

• Change From Baseline in Eyelash Darkness as Measured by DIA

  Baseline, Month 4

Study Arms (2)

bimatoprost solution 0.03%

EXPERIMENTAL

One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.

Drug: bimatoprost solution 0.03%

bimatoprost vehicle solution

PLACEBO COMPARATOR

One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

Drug: bimatoprost vehicle solution

Interventions

bimatoprost solution 0.03% DRUG

One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.

Also known as: LATISSE®

bimatoprost solution 0.03%

bimatoprost vehicle solution DRUG

One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

bimatoprost vehicle solution

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have inadequate eyelashes due to chemotherapy treatment
• Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
• Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss

You may not qualify if:

• Any disease/infection/abnormality of the eye or area around the eye
• Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
• Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
• Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
• Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
• Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Chiba, Japan

Location

Related Publications (1)

• Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19.

  PMID: 24643895 BACKGROUND

MeSH Terms

Interventions

Bimatoprost

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: May 25, 2012
• Study Completion: May 25, 2012
• Last Updated: July 8, 2019
• Results First Posted: July 9, 2013

Record last verified: 2019-04

Locations

JP (1)