NCT00375570

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 18, 2008

Status Verified

August 1, 2008

Enrollment Period

11 months

First QC Date

September 12, 2006

Last Update Submit

August 14, 2008

Conditions

Herpes Labialis

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    3 weeks after last dose

Study Arms (1)

1

EXPERIMENTAL

ME-609

Drug: ME-609

Interventions

ME-609DRUG

Topical treatment 5 times daily for 5 days

1

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • General good health
  • History of recurrent herpes labialis with at two recurrences during the last twelve months

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Herpes Labialis

Interventions

ME 609

Condition Hierarchy (Ancestors)

Herpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralLip DiseasesMouth DiseasesStomatognathic DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anders Strand, MD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 18, 2008

Record last verified: 2008-08