Clinical trial NCT01574612: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Labialis
Keywords: Xerese
acyclovir hydrocortisone cream
herpes labialis
pediatric
Lead sponsor: Meda Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: TKL Research, Inc.
First posted: 2012-04-10
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Reporting of Adverse Events
timeFrame: day 1 to day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: MCS Clinical Trials
state: California
city: Opa-Locka
country: United States
facility: Sunshine Research Center
state: Florida
city: West Palm Beach
country: United States
facility: Altus Rsearch,INC
state: Florida
city: Addison
country: United States
facility: Provident Clincal Research
state: Illinois
city: Lexington
country: United States
facility: Central Kentucky Research
state: Kentucky
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Winston-Salem
country: United States
facility: PGM Research of Winston-Salem, LLC
state: North Carolina
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Corsicana
country: United States
facility: Corsicana Medical Research,PNC
state: Texas
city: Richmond
country: United States
facility: National Clinical Research-Richmond,Inc.
state: Virginia
Study officials:
affiliation: Meda Pharma US
name: David Ginsburg, D.O.
role: STUDY_DIRECTOR
References: