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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01574612
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
TKL Research, Inc.
Information provided by (Responsible Party):
Meda Pharmaceuticals

April 5, 2012
April 10, 2012
February 25, 2014
May 22, 2014
May 22, 2014
March 2012
December 2012   (Final data collection date for primary outcome measure)
Reporting of Adverse Events [ Time Frame: day 1 to day 21 ]
treatment period is for 5 days and follow up visits at 7days and 21 days after first dose
Same as current
Complete list of historical versions of study NCT01574612 on Archive Site
Not Provided
Not Provided
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Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
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
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.
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Herpes Labialis
Drug: acyclovir/hydrocortisone cream
cream applied topically to lesion five times daily for five days
Other Name: Xerese(r)
Experimental: topical cream acyclovir/hydrocortisone
topical cream acyclovir/hydrocortisone used
Intervention: Drug: acyclovir/hydrocortisone cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
December 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
6 Years to 11 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
MP 800
Not Provided
Not Provided
Meda Pharmaceuticals
Meda Pharmaceuticals
TKL Research, Inc.
Study Director: David Ginsburg, D.O. Meda Pharma US
Meda Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP