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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary:
Sponsor: Meda Pharmaceuticals

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Meda Pharmaceuticals

Dates:
Date Received: April 5, 2012
Date Started: March 2012
Date Completion:
Last Updated: April 28, 2014
Last Verified: April 2014