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

This study has been completed.
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01574612
First received: April 5, 2012
Last updated: April 28, 2014
Last verified: April 2014

April 5, 2012
April 28, 2014
March 2012
December 2012   (final data collection date for primary outcome measure)
Reporting of Adverse Events [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: Yes ]
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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
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)
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01574612
MP 800
No
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