Trial | NCT01308424

Trial | NCT01308424 Report issue

Title

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

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

Phase
Phase 1/Phase 2

Lead Sponsor
Beech Tree Labs, Inc.

Study Type
Interventional

Status
Completed Results Posted

Indication/Condition
Oral Herpes Simplex

Intervention/Treatment
Thimerosal ...
BTL TML HSV Matching placebo

Study Participants
171

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

Study Started

Jan 31

2011

Primary Completion

Oct 31

2012

Study Completion

Nov 30

2012

Results Posted

Aug 13

2013

Estimate

Last Update

Aug 13

2013

Estimate

Drug BTL TML HSV

Sublingual micro-dosing for 7 days

Drug Matching placebo

sublingual dosing for 7 days

BTL TML HSV Experimental

Drug BTL TML HSV

Matching Placebo Placebo Comparator

Drug Matching placebo

Criteria

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

Summary

Baseline Run In

Matching Placebo

BTL TML HSV

All Events

Event Type	Organ System	Event Term	Baseline Run In	Matching Placebo	BTL TML HSV

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.

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