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

An Open Label, Multi-Centre, Phase III, Subject Initiated Safety Study of ME-609 in Treatment of Recurrent Herpes Simplex Labialis in Adolescents

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

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 5-time daily topical administration.

Inclusion Criteria:

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

Exclusion Criteria:

• 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)