Phase 2
Completed N=158
Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores
Oral Herpes Simplex
Source: ClinicalTrials.gov NCT01902303 ↗
Enrolled (actual)
158
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator — 6; 11 participants who had aborted lesions — p=>.5000
Summary
The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator |
6; 11 | >.5000 |
| SECONDARY Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant |
6; 8 | .3835 |
Eligibility Criteria
Inclusion Criteria
- Clinical history of recurrent cold sores averaging 2 or more episodes per year
- UV exposure is known to cause a cold sore outbreak
Exclusion Criteria
- History of abnormal reactions to sunlight
- Used antiviral therapy directly prior to entering study
- Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.
Data sourced from ClinicalTrials.gov (NCT01902303). 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.