Trial Outcomes & Findings for An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode (NCT NCT01653509)
NCT ID: NCT01653509
Last Updated: 2014-07-16
Results Overview
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.
COMPLETED
PHASE1
60 participants
Baseline to Day 10
2014-07-16
Participant Flow
Participants were recruited at the clinical site.
105 screened, 60 underwent ultraviolet (UV) rays induction, 25 developed a cold sore and were randomized into the study.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Baseline characteristics by cohort
| Measure |
Acyclovir Patch
n=12 Participants
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.
|
Placebo Patch
n=13 Participants
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.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 14.88 • n=5 Participants
|
43.2 Years
STANDARD_DEVIATION 15.60 • n=7 Participants
|
45.3 Years
STANDARD_DEVIATION 15.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 10Population: 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.
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.
Outcome measures
| Measure |
Acyclovir Patch
n=12 Participants
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.
|
Placebo Patch
n=13 Participants
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
|
|---|---|---|
|
Mean Change From Baseline in Blood Flow
TEV (Day 1 to Day 10)
|
2558.65 Perfusion Units
Standard Error 627.87
|
3470.13 Perfusion Units
Standard Error 603.23
|
|
Mean Change From Baseline in Blood Flow
MEV
|
809.88 Perfusion Units
Standard Error 127.93
|
960.86 Perfusion Units
Standard Error 122.91
|
PRIMARY outcome
Timeframe: Baseline to Day 10Population: ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.
Lesion thermographic parameters for TEV and MEV were analysed.
Outcome measures
| Measure |
Acyclovir Patch
n=12 Participants
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.
|
Placebo Patch
n=13 Participants
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
|
|---|---|---|
|
Mean Change From Baseline in Temperature
TEV (Day 1 to Day 10)
|
3.24 Degree celsius
Standard Error 0.86
|
0.76 Degree celsius
Standard Error 0.82
|
|
Mean Change From Baseline in Temperature
MEV
|
0.90 Degree celsius
Standard Error 0.15
|
0.51 Degree celsius
Standard Error 0.15
|
PRIMARY outcome
Timeframe: Baseline to Day 10Population: ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.
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).
Outcome measures
| Measure |
Acyclovir Patch
n=12 Participants
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.
|
Placebo Patch
n=13 Participants
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
|
|---|---|---|
|
Mean Change From Baseline in Color Intensity of Lesions
TEV
|
11.05 Units on a scale
Standard Error 1.12
|
8.91 Units on a scale
Standard Error 1.07
|
|
Mean Change From Baseline in Color Intensity of Lesions
MEV
|
2.66 Units on a scale
Standard Error 0.22
|
2.29 Units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Day 5Population: 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".
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: 1. Today my sore felt completely protected 2. Today my cold sores interfered with facial movements such as smiling, eating or drinking 3. Today my cold sores interfered with my interaction with other people 4. Today the patch disguised my cold sores 5. Today I was bothered by the appearance of my cold sores 6. Today my patch was easy to apply 7. Today the patch covering my cold sores was bothersome 8. Today the patches stayed in place on my cold sores until I removed them 9. Today the patches were easy to remove from my lip or skin
Outcome measures
| Measure |
Acyclovir Patch
n=12 Participants
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.
|
Placebo Patch
n=13 Participants
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
|
|---|---|---|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Protection (n = 11, 12)
|
4.45 Units on a scale
Standard Deviation 0.69
|
4.17 Units on a scale
Standard Deviation 1.12
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Facial Movements (n = 11, 12)
|
2.18 Units on a scale
Standard Deviation 1.33
|
2.75 Units on a scale
Standard Deviation 1.60
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Interpersonal Interaction (n = 11, 12)
|
2.09 Units on a scale
Standard Deviation 1.45
|
1.75 Units on a scale
Standard Deviation 0.97
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Cold Sore Cover (n = 11, 12)
|
4.45 Units on a scale
Standard Deviation 0.93
|
3.92 Units on a scale
Standard Deviation 1.31
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Cold sore appearance (n = 11, 12)
|
1.55 Units on a scale
Standard Deviation 0.93
|
1.67 Units on a scale
Standard Deviation 1.16
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Ease of application (n = 11, 12)
|
4.55 Units on a scale
Standard Deviation 0.69
|
4.00 Units on a scale
Standard Deviation 1.04
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Bothersomeness (n = 11, 12)
|
1.55 Units on a scale
Standard Deviation 0.93
|
1.55 Units on a scale
Standard Deviation 0.45
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Adhesivenes (n = 11, 12)
|
4.36 Units on a scale
Standard Deviation 0.92
|
3.75 Units on a scale
Standard Deviation 0.97
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 5
Patch removal (n = 9, 10)
|
4.33 Units on a scale
Standard Deviation 1.00
|
4.60 Units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Day 10Population: 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".
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: 1. Today my sore felt completely protected 2. Today my cold sores interfered with facial movements such as smiling, eating or drinking 3. Today my cold sores interfered with my interaction with other people 4. Today the patch disguised my cold sores 5. Today I was bothered by the appearance of my cold sores 6. Today my patch was easy to apply 7. Today the patch covering my cold sores was bothersome 8. Today the patches stayed in place on my cold sores until I removed them 9. Today the patches were easy to remove from my lip or skin
Outcome measures
| Measure |
Acyclovir Patch
n=12 Participants
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.
|
Placebo Patch
n=13 Participants
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
|
|---|---|---|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Protection (n= 4, 7)
|
4.50 Units on a scale
Standard Deviation 1.00
|
4.14 Units on a scale
Standard Deviation 1.07
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Facial Movements (n= 4, 7)
|
1.50 Units on a scale
Standard Deviation 1.00
|
2.29 Units on a scale
Standard Deviation 1.11
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Interpersonal Interaction (n= 4, 7)
|
1.50 Units on a scale
Standard Deviation 0.58
|
1.14 Units on a scale
Standard Deviation 0.38
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Cold Sore Coverage (n= 4, 7)
|
4.75 Units on a scale
Standard Deviation 0.50
|
4.57 Units on a scale
Standard Deviation 0.54
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Cold sore appearance (n= 4, 7)
|
1.50 Units on a scale
Standard Deviation 0.58
|
1.14 Units on a scale
Standard Deviation 0.38
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Ease of application (n= 4, 7)
|
4.75 Units on a scale
Standard Deviation 0.50
|
4.86 Units on a scale
Standard Deviation 0.38
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Bothersomeness (n= 4, 7)
|
1.50 Units on a scale
Standard Deviation 1.00
|
2.43 Units on a scale
Standard Deviation 1.40
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Adhesiveness (n= 4, 7)
|
4.75 Units on a scale
Standard Deviation 0.50
|
3.86 Units on a scale
Standard Deviation 1.35
|
|
Participant Assessment of Patch Comfort and Noticeability at Day 10
Patch removal (n = 3, 5)
|
4.33 Units on a scale
Standard Deviation 0.58
|
4.60 Units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Day 5Population: 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".
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.
Outcome measures
| Measure |
Acyclovir Patch
n=12 Participants
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.
|
Placebo Patch
n=13 Participants
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
|
|---|---|---|
|
Participant Assessment of Symptom Intensity at Day 5
Pain/Soreness (n = 11, 12)
|
1.55 Units on a scale
Standard Deviation 0.82
|
1.75 Units on a scale
Standard Deviation 1.22
|
|
Participant Assessment of Symptom Intensity at Day 5
Itching (n = 11, 12)
|
1.18 Units on a scale
Standard Deviation 0.41
|
1.67 Units on a scale
Standard Deviation 0.99
|
|
Participant Assessment of Symptom Intensity at Day 5
Burning (n = 11, 12)
|
1.36 Units on a scale
Standard Deviation 0.67
|
1.42 Units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Day 10Population: 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".
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.
Outcome measures
| Measure |
Acyclovir Patch
n=12 Participants
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.
|
Placebo Patch
n=13 Participants
Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
|
|---|---|---|
|
Participant Assessment of Symptom Intensity at Day 10
Burning (n = 4, 7)
|
1.00 Units on a scale
Standard Deviation 0.00
|
1.00 Units on a scale
Standard Deviation 0.00
|
|
Participant Assessment of Symptom Intensity at Day 10
Pain/Soreness (n = 4, 7)
|
1.00 Units on a scale
Standard Deviation 0.00
|
1.29 Units on a scale
Standard Deviation 0.49
|
|
Participant Assessment of Symptom Intensity at Day 10
Itching (n = 4, 7)
|
1.00 Units on a scale
Standard Deviation 0.00
|
1.14 Units on a scale
Standard Deviation 0.38
|
Adverse Events
Acyclovir Patch
Placebo Patch
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acyclovir Patch
n=12 participants at risk
Participants applied single patch containing acyclovir to the cold sore area.
|
Placebo Patch
n=13 participants at risk
Participants applied single placebo patch to the cold sore area.
|
|---|---|---|
|
Gastrointestinal disorders
Lip Erosion
|
0.00%
0/12 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/12 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/12 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER