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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01229423
First received: October 25, 2010
Last updated: December 16, 2011
Last verified: December 2011
History of Changes

October 25, 2010
December 16, 2011
November 2009
June 2010   (final data collection date for primary outcome measure)
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.
Upper Eyelash Length [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01229423 on ClinicalTrials.gov Archive Site
  • 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."
  • Assessment of Overall Eyelash Prominence using the 4-point Global Eyelash Assessment (GEA) Scale [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Subject's Satisfaction using the Subject Assessment Questionnaire [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
Not Provided

This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Eyelash Hypotrichosis
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®
Experimental: LATISSE®
bimatoprost 0.03% (LATISSE®)
Intervention: Drug: bimatoprost 0.03%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
October 2010
June 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01229423
LAT-KOR-01
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP