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

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ClinicalTrials.gov Identifier: NCT01229423
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : January 23, 2012
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Eyelash Hypotrichosis Drug: bimatoprost 0.03% Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Loss
Drug Information available for: Bimatoprost
U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  1. Change From Baseline in Eyelash Length at Week 20 [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20 [ Time Frame: 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.

  2. Change From Baseline in Eyelash Thickness at Week 20 [ Time Frame: Baseline, 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.

  3. Change From Baseline in Eyelash Intensity (Darkness) at Week 20 [ Time Frame: Baseline, 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.

  4. Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20 [ Time Frame: 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.

  5. Percentage of Subjects Satisfied With Treatment at Week 20 [ Time Frame: 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."



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229423


Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229423     History of Changes
Other Study ID Numbers: LAT-KOR-01
First Posted: October 27, 2010    Key Record Dates
Results First Posted: January 23, 2012
Last Update Posted: January 23, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Antihypertensive Agents