Phase 2
N=242
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
Oral Herpes Simplex
Bottom Line
View on ClinicalTrials.gov: NCT01308424 ↗Enrolled (actual)
242
Serious AEs
0.8%
Results posted
Aug 2013
Primary outcome: 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). — 77.8; 45.5 percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BTL TML HSV (Drug); Matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beech Tree Labs, Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
77.8; 45.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01308424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.