Restasis for Treatment of Brittle Nails

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Julian M. Mackay-Wiggan, Columbia University
ClinicalTrials.gov Identifier:
NCT00986427
First received: September 29, 2009
Last updated: July 17, 2013
Last verified: July 2013
Results First Received: May 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Brittle Nails
Interventions: Drug: Restasis (cyclosporine ophthalmic emulsion) 0.05%
Drug: Refresh® Dry Eye therapy

  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
24 patients recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Restasis® Arm Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
Refresh® Arm Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.

Participant Flow:   Overall Study
    Restasis® Arm     Refresh® Arm  
STARTED     12     12  
COMPLETED     8     12  
NOT COMPLETED     4     0  
Lost to Follow-up                 2                 0  
Lack of Efficacy                 1                 0  
Withdrawal by Subject                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Restasis® Arm Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
Refresh® Arm Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
Total Total of all reporting groups

Baseline Measures
    Restasis® Arm     Refresh® Arm     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: years]
Mean ± Standard Deviation
  59.8  ± 49.40     59.6  ± 12.69     59.7  ± 13.28  
Gender  
[units: participants]
     
Female     10     11     21  
Male     2     1     3  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2   [ Time Frame: Baseline, week 24 ]

2.  Secondary:   Change From Baseline in Quality of Life (QOL) Related to Nail Disease   [ Time Frame: Baseline, week 24 ]

3.  Secondary:   Growth of the Treated and Untreated Nail in the Previous 4 Weeks   [ Time Frame: Week 24 ]

4.  Secondary:   Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)   [ Time Frame: Week 24 ]


  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
Small Sample Size


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Julian Mackay-Wiggan, MD
Organization: Columbia University Dept of Dermatology
phone: 212-305-6953
e-mail: jc299@columbia.edu


No publications provided


Responsible Party: Julian M. Mackay-Wiggan, Columbia University
ClinicalTrials.gov Identifier: NCT00986427     History of Changes
Other Study ID Numbers: AAAD9927, Res-01-2009
Study First Received: September 29, 2009
Results First Received: May 10, 2013
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration