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

• Sponsor: Medivir (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00375570
• Collaborator: (none)
• Enrollment: 254
• Arm: 1
• Duration (Months): 11

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Oct 1, 2006
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse Event [3 weeks after last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medivir

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00375570
• Other Study ID Numbers: 609-07
• First Posted: Sep 13, 2006
• Last Update Posted: Aug 18, 2008
• Last Verified: Aug 1, 2008

• Additional relevant MeSH terms: Herpes Simplex; Herpes Labialis

Study Results

No Results Posted as of Aug 18, 2008