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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229423
First Posted: October 27, 2010
Last Update Posted: January 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
Results First Submitted: December 16, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Eyelash Hypotrichosis
Intervention: Drug: bimatoprost 0.03%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
LATISSE® bimatoprost 0.03% (LATISSE®)

Participant Flow:   Overall Study
    LATISSE®
STARTED   62 
COMPLETED   47 
NOT COMPLETED   15 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
LATISSE® bimatoprost 0.03% (LATISSE®)

Baseline Measures
   LATISSE® 
Overall Participants Analyzed 
[Units: Participants]
 62 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.3  (6.69) 
Gender 
[Units: Participants]
 
Female   62 
Male   0 


  Outcome Measures
  Show All Outcome Measures

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

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

3.  Secondary:   Change From Baseline in Eyelash Thickness at Week 20   [ Time Frame: Baseline, Week 20 ]

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

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

6.  Secondary:   Percentage of Subjects Satisfied With Treatment at Week 20   [ Time Frame: Week 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President, Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229423     History of Changes
Other Study ID Numbers: LAT-KOR-01
First Submitted: October 25, 2010
First Posted: October 27, 2010
Results First Submitted: December 16, 2011
Results First Posted: January 23, 2012
Last Update Posted: January 23, 2012