Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old

This study has been completed.
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01574612
First received: April 5, 2012
Last updated: April 28, 2014
Last verified: April 2014
Results First Received: February 25, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Herpes Labialis
Intervention: Drug: acyclovir/hydrocortisone cream

  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
Topical Cream

commercial product being used

acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days


Participant Flow:   Overall Study
    Topical Cream  
STARTED     54 [1]
COMPLETED     46  
NOT COMPLETED     8  
Adverse Event                 3  
non compliant with drug                 2  
Withdrawal by Subject                 1  
Lost to Follow-up                 2  
[1] patients who were identified as having the appropriate medical history of herpes labialis



  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
Topical Cream xerese topical cream is the only active used in this trial

Baseline Measures
    Topical Cream  
Number of Participants  
[units: participants]
  54  
Age  
[units: years]
Mean ± Standard Deviation
  9.1  ± 1.7  
Age  
[units: participants]
 
<=18 years     54  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     31  
Male     23  
Region of Enrollment  
[units: participants]
 
United States     54  
age of subjects with prior history of herpes labialis outbreak  
[units: participants]
 
less than or equal to 3 years     27  
age 4 to 6 years     17  
age 7 to 9 years     10  



  Outcome Measures

1.  Primary:   Reporting of Adverse Events   [ Time Frame: day 1 to day 21 ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Ginsberg, DO
Organization: Meda Pharmaceutical
phone: 732 564 2200
e-mail: ginsberg.david@gmail.com


No publications provided


Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01574612     History of Changes
Other Study ID Numbers: MP 800
Study First Received: April 5, 2012
Results First Received: February 25, 2014
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration