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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Herpes Labialis

Intervention / Treatment
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* Drug: acyclovir/hydrocortisone cream


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: topical cream acyclovir/hydrocortisone<br>topical cream acyclovir/hydrocortisone used | Drug: acyclovir/hydrocortisone cream<br>* cream applied topically to lesion five times daily for five days<br>* Other names: Xerese(r);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerese, acyclovir hydrocortisone cream, herpes labialis, pediatric