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 2Lead Sponsor
Beech Tree Labs, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Oral Herpes SimplexIntervention/Treatment
btl-tml-hsv ...Study Participants
171The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.
Sublingual micro-dosing for 7 days
sublingual dosing for 7 days
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
| Event Type | Organ System | Event Term | Baseline Run In | Matching Placebo | BTL TML HSV |
|---|
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.
