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Study of a Cold Sore Patch for the Treatment of Herpes Labialis

NCT01484067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2012-10-01

No results posted yet for this study

Summary

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 treatment routine.

Conditions

  • Herpes Labialis

Interventions

DEVICE

Patch ( Compeed© Total CareTM Cold Sore Patch)

A cold sore patch containing zinc sulfate

Sponsors & Collaborators

  • Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

    lead INDUSTRY

Principal Investigators

  • Clare Kendall · Johnson & Johsnon Consumer and Personal Products Worldwide

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01484067 on ClinicalTrials.gov