Safety Study of ME-609 for Treatment of 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.

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Key information

Conditions

Herpes Labialis DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ME-609

Drug

Topical treatment 5 times daily for 5 days

Primary outcomes

Adverse Event

Time frame: 3 weeks after last dose

Sponsors and collaborators

Lead sponsor

Medivir

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Sep 13, 2006
Registry last updated: Aug 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed