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

Medivir254 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

254

Conditions

Herpes Labialis

Interventions

ME-609DRUG

Topical treatment 5 times daily for 5 days

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Adverse Event

Time frame: 3 weeks after last dose

Data from ClinicalTrials.gov

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