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

Primary Purpose

Herpes Labialis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
acyclovir/hydrocortisone cream
Sponsored by
Meda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Labialis focused on measuring Xerese, acyclovir hydrocortisone cream, herpes labialis, pediatric

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • MCS Clinical Trials
  • Sunshine Research Center
  • Altus Rsearch,INC
  • Provident Clincal Research
  • Central Kentucky Research
  • Rochester Clinical Research
  • PGM Research of Winston-Salem, LLC
  • Clinical Partners LLC
  • Corsicana Medical Research,PNC
  • National Clinical Research-Richmond,Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

topical cream acyclovir/hydrocortisone

Arm Description

topical cream acyclovir/hydrocortisone used

Outcomes

Primary Outcome Measures

Reporting of Adverse Events
treatment period is for 5 days and follow up visits at 7days and 21 days after first dose

Secondary Outcome Measures

Full Information

First Posted
April 5, 2012
Last Updated
April 28, 2014
Sponsor
Meda Pharmaceuticals
Collaborators
TKL Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01574612
Brief Title
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meda Pharmaceuticals
Collaborators
TKL Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
Keywords
Xerese, acyclovir hydrocortisone cream, herpes labialis, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topical cream acyclovir/hydrocortisone
Arm Type
Experimental
Arm Description
topical cream acyclovir/hydrocortisone used
Intervention Type
Drug
Intervention Name(s)
acyclovir/hydrocortisone cream
Other Intervention Name(s)
Xerese(r)
Intervention Description
cream applied topically to lesion five times daily for five days
Primary Outcome Measure Information:
Title
Reporting of Adverse Events
Description
treatment period is for 5 days and follow up visits at 7days and 21 days after first dose
Time Frame
day 1 to day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ginsburg, D.O.
Organizational Affiliation
Meda Pharma US
Official's Role
Study Director
Facility Information:
Facility Name
MCS Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Sunshine Research Center
City
Opa-Locka
State/Province
Florida
ZIP/Postal Code
33054
Country
United States
Facility Name
Altus Rsearch,INC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Provident Clincal Research
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Central Kentucky Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
PGM Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Partners LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Corsicana Medical Research,PNC
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
National Clinical Research-Richmond,Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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