Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Labialis
Intervention: acyclovir/hydrocortisone cream (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Meda Pharmaceuticals Official(s) and/or principal investigator(s):
David Ginsburg, D.O., Study Director, Affiliation: Meda Pharma US
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.
Clinical Details
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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Reporting of Adverse Events
Eligibility
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
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)
Locations and Contacts
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
Additional Information
Starting date: March 2012
Last updated: April 28, 2014
|
