Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
Completed · Phase 3
Conditions studied: Herpes Labialis
In brief
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.
Key facts
- Study ID
- NCT01574612
- Run by
- Meda Pharmaceuticals
- People needed
- 54
- Starts
- 2012-03-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2014-05-22
Who can join
Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- MCS Clinical Trials — Los Angeles, California, United States
- Sunshine Research Center — Opa-locka, Florida, United States
- Altus Rsearch,INC — West Palm Beach, Florida, United States
- Provident Clincal Research — Addison, Illinois, United States
- Central Kentucky Research — Lexington, Kentucky, United States
- Rochester Clinical Research — Rochester, New York, United States
- PGM Research of Winston-Salem, LLC — Winston-Salem, North Carolina, United States
- Clinical Partners LLC — Johnston, Rhode Island, United States
- Corsicana Medical Research,PNC — Corsicana, Texas, United States
- National Clinical Research-Richmond,Inc. — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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