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

Eyelash Hypotrichosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229423
• Other study ID #: LAT-KOR-01
• Status: Completed
• Phase: Phase 4
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: January 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 LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eyelash prominence assessment of minimal or moderate

• Of Korean ethnicity

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Eyelash Hypotrichosis
• Hypotrichosis

Intervention

Drug:
• bimatoprost 0.03%
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20	Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.	Week 20
Secondary	Change From Baseline in Eyelash Thickness at Week 20	Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.	Baseline, Week 20
Secondary	Change From Baseline in Eyelash Intensity (Darkness) at Week 20	Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.	Baseline, Week 20
Secondary	Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20	Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question "Overall how satisfied are you with your eyelashes?" Responses were based on a 5-point scale ("very unsatisfied", "unsatisfied", "neutral", "satisfied", "very satisfied"). Improvement in subject satisfaction is defined as a 1-point increase from baseline.	Week 20
Secondary	Percentage of Subjects Satisfied With Treatment at Week 20	Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question "Which best describes your satisfaction with LATISSE®?" Responses were "very satisfied", "satisfied", "neutral", "unsatisfied", and "very unsatisfied." Satisfied is defined as responses of "very satisfied" and "satisfied."	Week 20