An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode

Conditions
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Herpes Labialis

Intervention / Treatment
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* Device: Acyclovir patch
* Device: Placebo patch


Participation Criteria
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Eligibility Criteria
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Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test patch<br>Patch containing acyclovir applied to cold sore | Device: Acyclovir patch<br>* Patch containing acyclovir<br>|
| Placebo Comparator: Placebo patch<br>Patch without acyclovir applied to cold sore | Device: Placebo patch<br>* Patch without acyclovir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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: Today my sore felt completely protected Today my cold sores interfered with facial movements such as smiling, eating or drinking Today my cold sores interfered with my interaction with other people Today the patch disguised my cold sores Today I was bothered by the appearance of my cold sores Today my patch was easy to apply Today the patch covering my cold sores was bothersome Today the patches stayed in place on my cold sores until I removed them Today the patches were easy to remove from my lip or skin | 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: Today my sore felt completely protected Today my cold sores interfered with facial movements such as smiling, eating or drinking Today my cold sores interfered with my interaction with other people Today the patch disguised my cold sores Today I was bothered by the appearance of my cold sores Today my patch was easy to apply Today the patch covering my cold sores was bothersome Today the patches stayed in place on my cold sores until I removed them Today the patches were easy to remove from my lip or skin | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cold sore