Herpes Labialis Clinical Trial
Official title:
A Randomized, Clinician-Blind, Clinical Study to Examine the Safety and Performance of Compeed© Total Careā¢ Cold Sore Patch With Zinc Sulfate for the Treatment of Herpes Labialis
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.
Status | Completed |
Enrollment | 472 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Intertek CRS | Manchester |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | Erythema | Clinician's score on a scale of 0-10 for erythema, where 0=none and 10=most severe | Within 10 Days | No |
Primary | Edema | Clinician's score on a scale of 0-10 for edema, where 0=none and 10=most severe | Within 10 Days | No |
Primary | Vesicles | Clinician's score on a scale of 0-10 for vesicles, where 0=none and 10=most severe | Within 10 Days | No |
Primary | Scab/Crust | Clinician's score on a scale of 0-10 for scab/crust, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Lesion Size | Measurement of lesion diameter | Within 10 Days | No |
Secondary | Lesion Stage | Lesion Stage on a categorical scale of 1-8, as described below: = prodrome (symptoms including itching, pain, tingling, but no physical evidence of disease by inspection or by palpation) = maculae (erythema) = papule (any elevation of skin without fluid; solid raised lesion) = vesicle (blister, fluid filled or collapsed) = ulcer/eroson (moist sore/wound) = soft crust/scab = hard crust/scab = healed (normal skin with no signs or symptoms; residual postlesion skin changes such as erythema, flaking, or slight asymmetry may be present) |
Within 10 Days | No |
Secondary | Pain | Subject's score for unprovoked pain on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Discomfort | Subject's score for discomfort on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Itching | Subject's score for itching on a scale of 0-10, where 0=none and 10=most severe | Within 10 days | No |
Secondary | Burning | Subject's score for burning on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Tingling | Subject's score for tingling on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Swelling | Subject's score for swelling on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Soreness/Tenderness | Subject's score for soreness/tenderness [upon touching] on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Redness | Subject's score for redness on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Blisters | Subject's score for blisters on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
Secondary | Scab or Crust | Subject's score for scab or crust on a scale of 0-10, where 0=none and 10=most severe | Within 10 Days | No |
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