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

Phase 3

Completed

• Conditions: Herpes Labialis
• Interventions: Drug: acyclovir/hydrocortisone cream

• Registration Number: NCT01574612
• Lead Sponsor: Meda Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-10
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Results First Submitted: 2014-02-25
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-28
• Last Update Submitted: 2014-04-28
• Results First Posted: 2014-05-22
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
topical cream acyclovir/hydrocortisone	acyclovir/hydrocortisone cream	topical cream acyclovir/hydrocortisone used

Primary Outcome Measures

Name	Time	Method
Reporting of Adverse Events	day 1 to day 21	treatment period is for 5 days and follow up visits at 7days and 21 days after first dose

Trial Locations

Locations (10)

Altus Rsearch,INC; 🇺🇸 West Palm Beach, Florida, United States

Provident Clincal Research; 🇺🇸 Addison, Illinois, United States

MCS Clinical Trials; 🇺🇸 Los Angeles, California, United States

Corsicana Medical Research,PNC; 🇺🇸 Corsicana, Texas, United States

Central Kentucky Research; 🇺🇸 Lexington, Kentucky, United States

Sunshine Research Center; 🇺🇸 Opa-Locka, Florida, United States

Clinical Partners LLC; 🇺🇸 Johnston, Rhode Island, United States

Rochester Clinical Research; 🇺🇸 Rochester, New York, United States

National Clinical Research-Richmond,Inc.; 🇺🇸 Richmond, Virginia, United States

PGM Research of Winston-Salem, LLC; 🇺🇸 Winston-Salem, North Carolina, United States