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
  • Study Type

    Interventional
  • Intervention/Treatment

    btl-tml-hsv ...
  • 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

Matching Placebo Placebo Comparator

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.

Matching Placebo

77.8
percentage of Participants

BTL TML HSV

45.5
percentage of Participants

Total

171
Participants

Age Continuous

43.3
years (Mean)
Full Range: 19.2 to 76.9

Region of Enrollment

Sex: Female, Male

Baseline Eligibility

Baseline Run In

Randomization

Matching Placebo

BTL TML HSV

Drop/Withdrawal Reasons

Baseline Run In

Matching Placebo

BTL TML HSV