Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection

Oral Herpes Simplex Clinical Trial

Official title:

A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of BTL-TML-HSV for the Treatment of Recurrent Symptomatic Oral Herpes Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308424
• Other study ID #: 2010-03-0112
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 2, 2011
• Last updated: August 12, 2013
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: August 2013
• Source: Beech Tree Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical history of recurrent cold sores averaging 2 or more episodes per year

• Experiences prodromal symptoms (tingling, burning, itching) of cold sores

• Herpes Simplex Virus seropositive (by blood test)

Exclusion Criteria:

• Immuno-suppressed or taking immunosuppressant medication

• Use of antiviral therapy directly prior and during the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex
• Herpesviridae Infections
• Oral Herpes Simplex
• Virus Diseases

Intervention

Drug:
• BTL TML HSV
Sublingual micro-dosing for 7 days
• Matching placebo
sublingual dosing for 7 days

Locations

Country	Name	City	State
United States	School of Dental Medicine, University at Buffalo	Buffalo	New York
United States	University of Kentucky College of Dentistry/Center for Oral Health Research	Lexington	Kentucky
United States	Family Dentistry	Norwich	New York
United States	University of Pittsburgh School of Dental Medicine	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Beech Tree Labs, Inc.	Norwich Clinical Research Associates Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).	Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.	7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)	No