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| Name | Class |
|---|---|
| Labtec GmbH | INDUSTRY |
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This study will treat approximately 24 participants who experience cold sores. Patches will be applied to the cold sore for up to ten days, and the symptoms will be measured during daily clinic visits using non-invasive measurement techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test patch | Experimental | Patch containing acyclovir applied to cold sore |
|
| Placebo patch | Placebo Comparator | Patch without acyclovir applied to cold sore |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acyclovir patch | Device | Patch containing acyclovir |
| |
| Placebo patch |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Blood Flow | Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique. Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days. | Baseline to Day 10 |
| Mean Change From Baseline in Temperature | Lesion thermographic parameters for TEV and MEV were analysed. | Baseline to Day 10 |
| Mean Change From Baseline in Color Intensity of Lesions | The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity). | Baseline to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Assessment of Patch Comfort and Noticeability at Day 5 | Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
|
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Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proDERM Institute for Applied Dermatological Research GmbH | Hamburg | 22869 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33913104 | Derived | Veltri J, Boon R, Bohling A, Wilhelm KP, Bielfeldt S. A Randomized Exploratory Study to Investigate the Inflammatory Response During an Ultraviolet-Radiation-Induced Cold Sore Episode. Dermatol Ther (Heidelb). 2021 Jun;11(3):983-994. doi: 10.1007/s13555-021-00531-x. Epub 2021 Apr 28. |
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105 screened, 60 underwent ultraviolet (UV) rays induction, 25 developed a cold sore and were randomized into the study.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acyclovir Patch | Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. |
| FG001 | Placebo Patch | Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acyclovir Patch | Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population. |
| BG001 | Placebo Patch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change From Baseline in Blood Flow | Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique. Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days. | Intent to Treat (ITT) population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. | Posted | Least Squares Mean | Standard Error | Perfusion Units | Baseline to Day 10 |
|
Adverse events were collected from UV exposure until the study completion assessments or the telephone follow-up for those participants not undergoing study completion assessments.
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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 | Acyclovir Patch | Participants applied single patch containing acyclovir to the cold sore area. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lip Erosion | Gastrointestinal disorders |
The study was not formally powered to detect statistically significant differences, but to provide information for methods development and develop sample size calculation for future studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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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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| Device |
Patch without acyclovir |
|
| Day 5 |
| Participant Assessment of Patch Comfort and Noticeability at Day 10 | Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
| Day 10 |
| Participant Assessment of Symptom Intensity at Day 5 | Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time. | Day 5 |
| Participant Assessment of Symptom Intensity at Day 10 | Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time. | Day 10 |
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo Patch |
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. |
|
|
|
| Primary | Mean Change From Baseline in Temperature | Lesion thermographic parameters for TEV and MEV were analysed. | ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. | Posted | Least Squares Mean | Standard Error | Degree celsius | Baseline to Day 10 |
|
|
|
|
| Primary | Mean Change From Baseline in Color Intensity of Lesions | The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity). | ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Day 10 |
|
|
|
|
| Secondary | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
| ITT population: all randomized participants who had a patch applied to their cold sore and had at least one post-baseline efficacy measurement. There were difference in number of participants analyzed for each end point as represented by "n". | Posted | Mean | Standard Deviation | Units on a scale | Day 5 |
|
|
|
| Secondary | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
| ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by "n". | Posted | Mean | Standard Deviation | Units on a scale | Day 10 |
|
|
|
| Secondary | Participant Assessment of Symptom Intensity at Day 5 | Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time. | ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by "n". | Posted | Mean | Standard Deviation | Units on a scale | Day 5 |
|
|
|
| Secondary | Participant Assessment of Symptom Intensity at Day 10 | Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time. | ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in the number of participants analyzed for each end point, as represented by "n". | Posted | Mean | Standard Deviation | Units on a scale | Day 10 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo Patch | Participants applied single placebo patch to the cold sore area. | 0 | 13 | 3 | 13 |
| Oral Herpes | Infections and infestations |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |
| Null hypothesis considered no difference between study treatments for MEV. | ANOVA | ANOVA model with a factor for treatment group. | 0.0799 | LS Mean Difference | 0.38 | 2-Sided | 95 | -0.05 | 0.82 | Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment. | No | Superiority or Other |
|
Null hypothesis considered no difference between study treatments for MEV. |
| ANOVA |
ANOVA model with a factor for treatment group. |
| 0.2446 |
| LS mean difference |
| 0.37 |
| 2-Sided |
| 95 |
| -0.27 |
| 1.00 |
Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment. |
| No |
| Superiority or Other |
| Interpersonal Interaction (n = 11, 12) |
|
| Cold Sore Cover (n = 11, 12) |
|
| Cold sore appearance (n = 11, 12) |
|
| Ease of application (n = 11, 12) |
|
| Bothersomeness (n = 11, 12) |
|
| Adhesivenes (n = 11, 12) |
|
| Patch removal (n = 9, 10) |
|
| Interpersonal Interaction (n= 4, 7) |
|
| Cold Sore Coverage (n= 4, 7) |
|
| Cold sore appearance (n= 4, 7) |
|
| Ease of application (n= 4, 7) |
|
| Bothersomeness (n= 4, 7) |
|
| Adhesiveness (n= 4, 7) |
|
| Patch removal (n = 3, 5) |
|
| Burning (n = 11, 12) |
|
| Burning (n = 4, 7) |
|