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

NCT01574612 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-05-22

Study results available
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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

DRUG

acyclovir/hydrocortisone cream

cream applied topically to lesion five times daily for five days

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Meda Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Ginsburg, D.O. · Meda Pharma US

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01574612 on ClinicalTrials.gov