A Randomized, Clinician-Blind, Clinical Study to Examine the Safety and Performance of Compeed© Total Care™ Cold Sore Patch With Zinc Sulfate for the Treatment of Herpes Labialis
Abstract
If a person qualifies to participate in this study, they will have an equal chance of being assigned to either of two groups. One group will receive a patch that they will need to carry with them, because as soon as a cold sore starts (within 1 hour) they will need to put the patch over the sore. The other group will not get a patch, but will need to follow the other instructions anyway.
When a subject's outbreak begins, they will need to return to the study center within 24 hours. Then they will return according to the appointments given within 10 days. If the study staff sees that their sore has healed enough before 10 days, subjects will be told that they don't need to return again.
As long as subjects are in the study, they will need to answer a few simple questions every day on a card or booklet called a diary, starting the first day of their outbreak. If a subject is assigned to the patch group, they must wear the patch all the time, taking it off only to replace it (if it gets loose, dirty, or unsightly) and at the study center, when they are asked to remove the patch so the sore can be checked.
During the study subjects will be allowed to use paracetamol for pain, but no other treatments or medicine. If they use paracetamol, subjects must record it in their diary. The study will be stopped, and there will be no subject visits or treatments during the end of year holiday break. If a subject experiences an outbreak during the holiday, they may follow their usual…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 472 participants or records.
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