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

Medivir

Status and phase: Completed; Phase 3

Conditions: Herpes Labialis

Treatments: Drug: ME-609

Study type: Interventional

Funder types: Industry

Identifiers

NCT00375570

609-07

Details and patient eligibility

About

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

Full 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 5-time daily topical administration.

Enrollment: 254 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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254 participants in 1 patient group

1

Experimental group

Description:

ME-609

Treatment:

Drug: ME-609