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

April 28, 2014 updated by: Meda Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90057
        • Mcs Clinical Trials
    • Florida
      • Opa-Locka, Florida, United States, 33054
        • Sunshine Research Center
      • West Palm Beach, Florida, United States, 33407
        • Altus Rsearch,INC
    • Illinois
      • Addison, Illinois, United States, 60101
        • Provident Clincal Research
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • PGM Research of Winston-Salem, LLC
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners LLC
    • Texas
      • Corsicana, Texas, United States, 75110
        • Corsicana Medical Research,PNC
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research-Richmond,Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Xerese(r)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1 to day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meda Pharmaceuticals

Collaborators

TKL Research, Inc.

Investigators

  • Study Director: David Ginsburg, D.O., Meda Pharma US

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP 800

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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