Phase 2
Completed N=242
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
Oral Herpes Simplex
Source: ClinicalTrials.gov NCT01308424 ↗
Enrolled (actual)
242
Serious AEs
0.8%
Results posted
Aug 2013
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.