Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores

NCT01902303 ↗

Phase 2 Completed 303 enrolled Beech Tree Labs, Inc. Hill Top Research · collab Norwich Clinical Research Associates Ltd. · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2013-07
Primary completion: 2014-09
Completion: 2015-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Matching Placebo vs BTL-TML-HSV Active Treatment; p >.5000; Chi-squared NCT01902303 ↗

paper Neither clinical trial showed a statistically significant effect of BTL-TML on progression to lesion. PMID 35142535 ↗

Publications

Mamber SW, Hatch T, Miller CS, Murray JV, Strout C, McMichael J. Low-dose Oral Thimerosal for the Treatment of Oral Herpes: Clinical Trial Results and Improved Outcome After Post-hoc Analysis. J Evid Based Integr Med. 2022 Jan-Dec;27:2515690X221078004. doi: 10.1177/2515690X221078004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BTL-TML-HSV	Unknown	—	Other