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

This study has been completed.
Sponsor:
Information provided by:
Medivir
ClinicalTrials.gov Identifier:
NCT00375570
First received: September 12, 2006
Last updated: August 14, 2008
Last verified: August 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Herpes Labialis
 Drug: ME-609
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multi-Centre, Phase III, Subject Initiated Safety Study of ME-609 in Treatment of Recurrent Herpes Simplex Labialis in Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medivir:

Primary Outcome Measures:
  • Adverse Event [ Time Frame: 3 weeks after last dose ] [ Designated as safety issue: Yes ]

Enrollment: 254
Study Start Date: October 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ME-609
 Drug: ME-609
Topical treatment 5 times daily for 5 days

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375570

Sponsors and Collaborators
Medivir
Investigators
Principal Investigator: Anders Strand, MD PhD Department of Medical Sciences, Dermatology and Venereology University Hospital, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Borje Darpo, MD, PhD, Medivir AB
ClinicalTrials.gov Identifier: NCT00375570     History of Changes
Other Study ID Numbers: 609-07
Study First Received: September 12, 2006
Last Updated: August 14, 2008
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013