Cold Sore
Conditions
Keywords
cold sore
Brief summary
Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.
Interventions
DRUGPenciclovir
Penciclovir every 2 hours during waking hours for 96 hours
DRUGPlacebo
Placebo every 2 hous during waking hours for 96 hours
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Be known to be a cold sore sufferer and presenting a prodromal stage with pain * Sign the written informed consent form prior to enrolment in the trial; * Be aged 18 to 75 years;
Exclusion criteria
* If female, are pregnant, planning pregnancy or lactating; * Have a known hypersensitivity to penciclovir or any ingredients of the vehicle; * Have already ongoing classical cold sore lesions at the baseline visit; * Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit; * Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment; * Are known to be immunosuppressed (acquired, congenital or therapeutic); * Have been involved in any investigational protocol within the 30 days prior to the trial; * Have evidence or history of drug or alcohol abuse;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. | 72 hours | Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Size of the Cold Sore | 72 hours | The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm. |
Countries
United Kingdom
Participant flow
Recruitment details
Study start : 30 dec 2008 Study end : 16 Nov 2009 Hospital out patient clinic
Pre-assignment details
Cold Sore confirmed by local temperature measurement
Participants by arm
| Arm | Count |
|---|---|
| Penciclovir Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours | 64 |
| Placebo Placebo cream every 2 hours during waking hours for 96 hours | 62 |
| Total | 126 |
Baseline characteristics
| Characteristic | Placebo | Penciclovir | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 63 Participants | 125 Participants |
| Age Continuous | 31.8 years STANDARD_DEVIATION 9.3 | 31.4 years STANDARD_DEVIATION 11.3 | 31.6 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United Kingdom | 62 participants | 64 participants | 126 participants |
| Sex: Female, Male Female | 40 Participants | 43 Participants | 83 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 62 |
| serious Total, serious adverse events | 0 / 64 | 0 / 62 |
Outcome results
Primary
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).
Time frame: 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penciclovir | Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. | 39 participants |
| Placebo | Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. | 32 participants |
Secondary
Size of the Cold Sore
The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.
Time frame: 72 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Penciclovir | Size of the Cold Sore | 31.7 square mm |
| Placebo | Size of the Cold Sore | 32.7 square mm |