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

Phase 1

Completed

• Conditions: Oral Herpes Simplex
• Interventions: Drug: BTL TML HSV; Drug: Matching placebo

• Registration Number: NCT01308424
• Lead Sponsor: Beech Tree Labs, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-04
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Results First Submitted: 2013-05-22
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-12
• Last Update Submitted: 2013-08-12
• Results First Posted: 2013-08-13
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTL TML HSV	BTL TML HSV	-
Matching Placebo	Matching placebo	-

Primary Outcome Measures

Name	Time	Method
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).	7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)	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.

Trial Locations

Locations (4)

University of Kentucky College of Dentistry/Center for Oral Health Research; 🇺🇸 Lexington, Kentucky, United States

School of Dental Medicine, University at Buffalo; 🇺🇸 Buffalo, New York, United States

University of Pittsburgh School of Dental Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States

Family Dentistry; 🇺🇸 Norwich, New York, United States