MedDataX Logo

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

NCT ID: NCT00375570

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Herpes Labialis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

ME-609

Group Type EXPERIMENTAL

ME-609

Intervention Type DRUG

Topical treatment 5 times daily for 5 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ME-609

Topical treatment 5 times daily for 5 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medivir

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Medivir AB

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anders Strand, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Sciences, Dermatology and Venereology University Hospital, Uppsala, Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

609-07

Identifier Type: -

Identifier Source: org_study_id