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NCT00375570 Clinical Trial

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

Herpes Labialis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00375570
Other study ID # 609-07
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2006
Last updated August 14, 2008
Start date October 2006
Est. completion date September 2007

Study information
Verified date August 2008
Source Medivir
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 254
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ME-609
Topical treatment 5 times daily for 5 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medivir

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Event 3 weeks after last dose Yes
See also
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Terminated NCT00913692 - A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis Phase 2
Completed NCT02207881 - A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis Phase 2
Completed NCT01653509 - An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode Phase 1
Completed NCT00361881 - Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis Phase 3
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