Study of a Cold Sore Patch for the Treatment of Herpes Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional

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.
    

Detailed description: 
      This is a two-arm, randomized, clinician-blind study. No severe adverse effects are expected
      to be experienced in the control group. All subjects are allowed to treat cold sore related
      pain with an oral analgesic - paracetamol (APAP). The use of APAP for pain will be recorded
      as a concomitant medication. However, subjects will be required to refrain from using any
      additional treatment (topical or systemic) during study participation.

      Subjects randomized to treatment will be instructed to initiate the therapy within 1 hour
      onset of their first sign or symptom and record their assessment in the diary card (for no
      treatment subjects, they will only record assessments upon onset of first sign or symptom).
      All subjects will return to the study center for clinical assessments within 24 hours and 48
      hours after onset of first sign or symptom/initiation of treatment and every other day
      thereafter, with a final visit at Day 10 or at the time of completion/discontinuation if
      before Day 10. Diaries will be completed each day, beginning upon initiation of therapy (Day
      0) and continuing until study completion/discontinuation, and will include information on
      study product applications.

      Subjects assigned to a patch treatment will wear a patch continuously on their lesion and
      will apply a new patch on occasions where the patch becomes loose, falls off or becomes
      unsightly, including at study visits to the facility where subjects will be asked to remove
      their patch for clinical assessments. Treatment will continue until the lesion is healed, for
      a maximum of 10 days. As the test period will possibly extend through the end of year holiday
      break, subject visits and treatments will be halted during this break. All subjects who have
      not initiated therapy including subjects assigned no treatment group, will be allowed to use
      their regular therapy for a cold sore outbreak during the holiday break.
    

Intervention name(s): Patch ( Compeed© Total CareTM Cold Sore Patch)
Intervention type(s): Device
Intervention description(s): A cold sore patch containing zinc sulfate
Other intervention name(s): Compeed© Total CareTM Cold Sore Patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Herpes Simplex Virus