Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects - Full Text View

Purpose

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

Condition	Intervention	Phase
Eyelash Hypotrichosis	Drug: bimatoprost 0.03%	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hair Loss

Drug Information available for: Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change From Baseline in Eyelash Length at Week 20 [ Time Frame: Baseline, Week 20 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20 [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
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.
Change From Baseline in Eyelash Thickness at Week 20 [ Time Frame: Baseline, Week 20 ] [ Designated as safety issue: No ]
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.
Change From Baseline in Eyelash Intensity (Darkness) at Week 20 [ Time Frame: Baseline, Week 20 ] [ Designated as safety issue: No ]
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.
Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20 [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
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.
Percentage of Subjects Satisfied With Treatment at Week 20 [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
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."

Enrollment:	62
Study Start Date:	November 2009
Study Completion Date:	October 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LATISSE® bimatoprost 0.03% (LATISSE®)	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. Other Name: LATISSE®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229423

Locations

Korea, Republic of

Seoul, Korea, Republic of

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01229423 History of Changes
Other Study ID Numbers:	LAT-KOR-01
Study First Received:	October 25, 2010
Results First Received:	December 16, 2011
Last Updated:	December 16, 2011
Health Authority:	Korea: Korean Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013