Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
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
1 other identifier
interventional
54
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
May 22, 2014
CompletedMay 22, 2014
April 1, 2014
9 months
April 5, 2012
February 25, 2014
April 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reporting of Adverse Events
treatment period is for 5 days and follow up visits at 7days and 21 days after first dose
day 1 to day 21
Study Arms (1)
topical cream acyclovir/hydrocortisone
EXPERIMENTALtopical cream acyclovir/hydrocortisone used
Interventions
cream applied topically to lesion five times daily for five days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meda Pharmaceuticalslead
- TKL Research, Inc.collaborator
Study Sites (10)
MCS Clinical Trials
Los Angeles, California, 90057, United States
Sunshine Research Center
Opa-locka, Florida, 33054, United States
Altus Rsearch,INC
West Palm Beach, Florida, 33407, United States
Provident Clincal Research
Addison, Illinois, 60101, United States
Central Kentucky Research
Lexington, Kentucky, 40509, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
PGM Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Clinical Partners LLC
Johnston, Rhode Island, 02919, United States
Corsicana Medical Research,PNC
Corsicana, Texas, 75110, United States
National Clinical Research-Richmond,Inc.
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Ginsberg, DO
- Organization
- Meda Pharmaceutical
Study Officials
- STUDY DIRECTOR
David Ginsburg, D.O.
Meda Pharma US
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 10, 2012
Study Start
March 1, 2012
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
May 22, 2014
Results First Posted
May 22, 2014
Record last verified: 2014-04