Study of a Cold Sore Patch for the Treatment of Herpes Labialis
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
2 other identifiers
interventional
472
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedOctober 1, 2012
September 1, 2012
4 months
November 30, 2011
September 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Overall Condition of Cold Sore
Taking into account the size, physical impression of the lesion and overall quality of healing, clinician will score the overall condition of the cold sore on a scale of 0-10, where 0=Best and 10=Worst.
Within 10 Days
Erythema
Clinician's score on a scale of 0-10 for erythema, where 0=none and 10=most severe
Within 10 Days
Edema
Clinician's score on a scale of 0-10 for edema, where 0=none and 10=most severe
Within 10 Days
Vesicles
Clinician's score on a scale of 0-10 for vesicles, where 0=none and 10=most severe
Within 10 Days
Scab/Crust
Clinician's score on a scale of 0-10 for scab/crust, where 0=none and 10=most severe
Within 10 Days
Secondary Outcomes (12)
Lesion Size
Within 10 Days
Lesion Stage
Within 10 Days
Pain
Within 10 Days
Discomfort
Within 10 Days
Itching
Within 10 days
- +7 more secondary outcomes
Study Arms (2)
Patch
EXPERIMENTALAt 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.
No Patch
NO INTERVENTIONNo 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.
Interventions
A cold sore patch containing zinc sulfate
Eligibility Criteria
You may qualify if:
- Female or male 18-70 years old in good general health
- 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)
You may not qualify if:
- Self-reported to be pregnant, planning to become pregnant or nursing
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intertek CRS
Manchester, M15 6SE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clare Kendall
Johnson & Johsnon Consumer and Personal Products Worldwide
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 2, 2011
Study Start
November 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
October 1, 2012
Record last verified: 2012-09