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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00375570

Enrollment

254

Registered

2006-09-13

Start date

2006-10-31

Completion date

2007-09-30

Last updated

2008-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Labialis

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 5-time daily topical administration.

Interventions

DRUGME-609

Topical treatment 5 times daily for 5 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

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)

Design outcomes

Primary

Measure	Time frame
Adverse Event	3 weeks after last dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026