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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penciclovir | Experimental | Penciclovir |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penciclovir | Drug | Penciclovir every 2 hours during waking hours for 96 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Lamey | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast Health and Social Care Trust, Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
Cold Sore confirmed by local temperature measurement
Study start : 30 dec 2008 Study end : 16 Nov 2009 Hospital out patient clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Penciclovir | Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours |
| FG001 | Placebo | Placebo cream every 2 hours during waking hours for 96 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Penciclovir | Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours |
| BG001 | Placebo | Placebo cream every 2 hours during waking hours for 96 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Nov 2010 | Number | participants | 72 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Penciclovir | Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research | Novartis Consumer Health | +4122363311 |
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| ID | Term |
|---|---|
| D006560 | Herpes Labialis |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C053539 | penciclovir |
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| Placebo |
| Drug |
Placebo every 2 hous during waking hours for 96 hours |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Posted | Nov 2010 | Mean | 95% Confidence Interval | square mm | 72 hours |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Placebo | Placebo cream every 2 hours during waking hours for 96 hours | 0 | 62 | 0 | 62 |
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| D007239 |
| Infections |
| D017193 | Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |