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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00375570
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : August 18, 2008
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Brief Summary:
The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent herpes labialis in adolescents.

Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: ME-609 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2006
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: ME-609
Topical treatment 5 times daily for 5 days

Primary Outcome Measures :
  1. Adverse Event [ Time Frame: 3 weeks after last dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375570

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

Responsible Party: Borje Darpo, MD, PhD, Medivir AB
ClinicalTrials.gov Identifier: NCT00375570     History of Changes
Other Study ID Numbers: 609-07
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008

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