NCT01574612

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Meda Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	acyclovir/hydrocortisone cream	cream applied topically to lesion five times daily for five days

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2012-04-10
• Last updated: 2014-05-22
• Results posted: 2014-05-22

Locations

10 sites across 1 country: United States