Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects

NCT01229423 | Completed Phase 4 Results

• 1 other identifier: LAT-KOR-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.

Conditions

Eyelash Hypotrichosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Eyelash Length at Week 20

  Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.

  Baseline, Week 20

Secondary Outcomes (5)

• Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20

  Week 20

• Change From Baseline in Eyelash Thickness at Week 20

  Baseline, Week 20

• Change From Baseline in Eyelash Intensity (Darkness) at Week 20

  Baseline, Week 20

• Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20

  Week 20

• Percentage of Subjects Satisfied With Treatment at Week 20

  Week 20

Study Arms (1)

LATISSE®

EXPERIMENTAL

bimatoprost 0.03% (LATISSE®)

Drug: bimatoprost 0.03%

Interventions

bimatoprost 0.03% DRUG

One drop of bimatoprost 0.03% (LATISSE®) applied evenly to each upper eyelid in the evening. Treatment is once daily for up to 40 weeks.

Also known as: LATISSE®

LATISSE®

Eligibility Criteria

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

You may qualify if:

• Eyelash prominence assessment of minimal or moderate
• Of Korean ethnicity

You may not qualify if:

• Any eye disease or abnormality
• Any ocular surgery or use of any eyelash extension or eyelash growth products within 3 months
• Any permanent eyeliner within 5 years
• Eyelash implants of any kind
• Eyelash tint or dye application within 2 months
• Use of any treatment that may affect hair growth within 6 months

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

• Kwon O, Kim JY, Paik SH, Jeon HC, Jung YJ, Lee Y, Baek JH, Chun JH, Lee WS, Lee JY, Rogers JD, Halstead M, Eun HC. Long-term utility and durability of the therapeutic effects of bimatoprost 0.03% for eyelash augmentation in healthy Asian subjects. Dermatology. 2014;229(3):222-9. doi: 10.1159/000363379. Epub 2014 Sep 6.

  PMID: 25228046 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: Vice President, Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 27, 2010
• Study Start: November 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 29, 2019
• Results First Posted: January 23, 2012

Record last verified: 2019-01

Locations

KR (1)