Status:

COMPLETED

Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents

Lead Sponsor:

Medivir

Conditions:

Herpes Labialis

Eligibility:

All Genders

12-17 years

Phase:

PHASE3

Brief Summary

The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent herpes labialis in adolescents.

Detailed Description

The objective of the study was to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day treatment with ...

Eligibility Criteria

Inclusion

  • General good health
  • History of recurrent herpes labialis with at two recurrences during the last twelve months

Exclusion

  • Treatment with systemic or topical antiviral agents or steroids within two weeks prior to inclusion
  • Significant skin condition that occur in the area of herpes recurrences
  • Nursing or/and pregnancy
  • Immunosupressed state due to underlying disease (e.g. HIV infection or concomitant treatment (e.g. cancer chemotherapy)

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2007

Estimated Enrollment :

254 Patients enrolled

Trial Details

Trial ID

NCT00375570

Start Date

October 1 2006

End Date

September 1 2007

Last Update

August 18 2008

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Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents | DecenTrialz