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

Eyelash Hypotrichosis Clinical Trial

Official title:

A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-daily Application of Bimatoprost Solution 0.03% Compared to Vehicle to Treat Chemotherapy-induced Hypotrichosis of the Eyelashes in Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391286
• Other study ID #: 192024-067
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2011
• Est. completion date: May 25, 2012

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 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 25, 2012
• Est. primary completion date: May 25, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Eyelash Hypotrichosis
• Hypotrichosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Japan, 

References & 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. Erratum in: Aesthetic Plast Surg. 2014 Oct;38(5):1071-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)	Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).	Baseline, Month 4
Secondary	Change From Baseline in Eyelash Thickness as Measured by DIA	Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).	Baseline, Month 4
Secondary	Change From Baseline in Eyelash Darkness as Measured by DIA	Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).	Baseline, Month 4