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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

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.

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Detailed Description

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Conditions

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Herpes Labialis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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topical cream acyclovir/hydrocortisone

topical cream acyclovir/hydrocortisone used

Group Type EXPERIMENTAL

acyclovir/hydrocortisone cream

Intervention Type DRUG

cream applied topically to lesion five times daily for five days

Interventions

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acyclovir/hydrocortisone cream

cream applied topically to lesion five times daily for five days

Intervention Type DRUG

Other Intervention Names

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Xerese(r)

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)

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No