Back to resultsAn Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Primary Purpose
Herpes Labialis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Acyclovir patch
Placebo patch
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis focused on measuring cold sore
Eligibility Criteria
Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
Sites / Locations
- proDERM Institute for Applied Dermatological Research GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test patch
Placebo patch
Arm Description
Patch containing acyclovir applied to cold sore
Patch without acyclovir applied to cold sore
Outcomes
Primary Outcome Measures
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.
Mean Change From Baseline in Temperature
Lesion thermographic parameters for TEV and MEV were analysed.
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).
Secondary Outcome Measures
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
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
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.
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.
Full Information
NCT ID
NCT01653509
First Posted
July 19, 2012
Last Updated
July 10, 2014
Sponsor
GlaxoSmithKline
Collaborators
Labtec GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01653509
Brief Title
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Official Title
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
Collaborators
Labtec GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
Keywords
cold sore
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test patch
Arm Type
Experimental
Arm Description
Patch containing acyclovir applied to cold sore
Arm Title
Placebo patch
Arm Type
Placebo Comparator
Arm Description
Patch without acyclovir applied to cold sore
Intervention Type
Device
Intervention Name(s)
Acyclovir patch
Intervention Description
Patch containing acyclovir
Intervention Type
Device
Intervention Name(s)
Placebo patch
Intervention Description
Patch without acyclovir
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Blood Flow
Description
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.
Time Frame
Baseline to Day 10
Title
Mean Change From Baseline in Temperature
Description
Lesion thermographic parameters for TEV and MEV were analysed.
Time Frame
Baseline to Day 10
Title
Mean Change From Baseline in Color Intensity of Lesions
Description
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).
Time Frame
Baseline to Day 10
Secondary Outcome Measure Information:
Title
Participant Assessment of Patch Comfort and Noticeability at Day 5
Description
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
Time Frame
Day 5
Title
Participant Assessment of Patch Comfort and Noticeability at Day 10
Description
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
Time Frame
Day 10
Title
Participant Assessment of Symptom Intensity at Day 5
Description
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.
Time Frame
Day 5
Title
Participant Assessment of Symptom Intensity at Day 10
Description
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.
Time Frame
Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
proDERM Institute for Applied Dermatological Research GmbH
City
Hamburg
ZIP/Postal Code
22869
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33913104
Citation
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.
Results Reference
derived
Learn more about this trial
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
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