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
Results First Received: December 16, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
No text entered.

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®  
Number of Participants  
[units: participants]
  62  
Age  
[units: years]
Mean ± Standard Deviation
  37.3  ± 6.69  
Gender  
[units: participants]
 
Female     62  
Male     0  



  Outcome Measures
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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


  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.


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


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)