Study of a Cold Sore Patch for the Treatment of Herpes Labialis
NCT ID: NCT01484067
Last Updated: 2012-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
472 participants
INTERVENTIONAL
2011-11-30
2012-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Patch
At onset of signs/symptoms, subjects will apply assigned patch, and return to study center within 24 hours. Patch will be worn continuously, being replaced as needed.
Patch ( Compeed© Total CareTM Cold Sore Patch)
A cold sore patch containing zinc sulfate
No Patch
No treatment will be initiated at onset of signs and symptoms although subject is still required to return to study center with 24 hours of onset of signs/symptoms.
No interventions assigned to this group
Interventions
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Patch ( Compeed© Total CareTM Cold Sore Patch)
A cold sore patch containing zinc sulfate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a history of Herpes Labialis in the areas and with the frequency defined in the protocol.
* Based on history, likely to experience a cold sore outbreak within next 2 to 3 months
* Willing to provide informed consent
* Willing to stop all other treatment of this condition and any topical products (lip balm, cosmetics, sunscreen) during test period
* Women of child bearing potential must agree to use an adequate method of birth control (systemic birth control/intrauterine device)
Exclusion Criteria
* Has any medical history or condition that might, per protocol or in the opinion of the investigator, compromise the subject's safety or the analysis of results.
* Is taking or has taken within the 28 days before commencing treatment, protocol-specified medications or herbal supplements.
18 Years
70 Years
ALL
No
Sponsors
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Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clare Kendall
Role: STUDY_DIRECTOR
Johnson & Johsnon Consumer and Personal Products Worldwide
Locations
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Intertek CRS
Manchester, , United Kingdom
Countries
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Other Identifiers
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44-DRM-HLS-11-002
Identifier Type: OTHER
Identifier Source: secondary_id
HCOWDH0003
Identifier Type: -
Identifier Source: org_study_id