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

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.
 
ClinicalTrials.gov Identifier: NCT01574612
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Meda Pharmaceuticals

Study Description
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Brief Summary:
To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.

Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: acyclovir/hydrocortisone cream Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Multi Center Phase III Subject/Caregiver Initiated Safety Study of Xerese(Acyclovir and Hydrocortisone)Cream 5%/1% in the Treatment of Recurrent Herpes Labialis in Children
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Arms and Interventions
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Arm Intervention/treatment
Experimental: topical cream acyclovir/hydrocortisone
topical cream acyclovir/hydrocortisone used
 Drug: acyclovir/hydrocortisone cream
cream applied topically to lesion five times daily for five days
Other Name: Xerese(r)


Outcome Measures
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Primary Outcome Measures :
  1. Reporting of Adverse Events [ Time Frame: day 1 to day 21 ]
    treatment period is for 5 days and follow up visits at 7days and 21 days after first dose


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age 6-11 years at time of enrollment
  • General good health, as judged by the Investigator
  • History of recurrent herpes labialis with at least two (2) recurrences during the last twelve (12) months, as based on interview with the subject or subject's caregiver
  • Agreement to refrain from using other topical medical, over-the counter (OTC), or cosmetic products in or around the oral area during the herpes recurrence
  • Agreement to refrain from mechanical disruption of the area affected by herpes labialis during the study recurrence
  • Subjects and their legally acceptable representative(s) must voluntarily sign and date the informed assent (subject) and consent (legally authorized representative).
  • Willingness to comply with all requirements of the study.

Exclusion Criteria:

  • Any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy)
  • Significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis or chronic vesiculobullous disorders
  • Administration of an investigational drug or within 30 days prior to inclusion, or concurrent participation in another research study
  • Administration of an immunomodulatory agent within the past 30 days
  • History of immediate hypersensitivity or serum sickness reaction to any nucleoside analog antiviral agent, or to any topical steroid, or to the vehicle
  • Clinically relevant abnormal physical findings at screening which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures Nursing or pregnant (Pubescent females require pregnancy testing)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574612


Locations
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United States, California
MCS Clinical Trials
Los Angeles, California, United States, 90057
United States, Florida
Sunshine Research Center
Opa-Locka, Florida, United States, 33054
Altus Rsearch,INC
West Palm Beach, Florida, United States, 33407
United States, Illinois
Provident Clincal Research
Addison, Illinois, United States, 60101
United States, Kentucky
Central Kentucky Research
Lexington, Kentucky, United States, 40509
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, North Carolina
PGM Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Rhode Island
Clinical Partners LLC
Johnston, Rhode Island, United States, 02919
United States, Texas
Corsicana Medical Research,PNC
Corsicana, Texas, United States, 75110
United States, Virginia
National Clinical Research-Richmond,Inc.
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Meda Pharmaceuticals
TKL Research, Inc.
Investigators
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Study Director: David Ginsburg, D.O. Meda Pharma US
More Information
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Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01574612    
Other Study ID Numbers: MP 800
First Posted: April 10, 2012    Key Record Dates
Results First Posted: May 22, 2014
Last Update Posted: May 22, 2014
Last Verified: April 2014
Keywords provided by Meda Pharmaceuticals:
Xerese
acyclovir hydrocortisone cream
herpes labialis
pediatric
Additional relevant MeSH terms:
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Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
 Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Hydrocortisone
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents