Herpes Labialis
Conditions
Keywords
cold sore
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.
Interventions
DEVICEAcyclovir patch
Patch containing acyclovir
DEVICEPlacebo patch
Patch without acyclovir
Sponsors
GlaxoSmithKline
Labtec GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Blood Flow | Baseline to Day 10 | 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 | Baseline to Day 10 | Lesion thermographic parameters for TEV and MEV were analysed. |
| Mean Change From Baseline in Color Intensity of Lesions | Baseline to Day 10 | 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
| Measure | Time frame | Description |
|---|---|---|
| Participant Assessment of Patch Comfort and Noticeability at Day 5 | 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: 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 |
| Participant Assessment of Symptom Intensity at Day 10 | 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. |
| Participant Assessment of Patch Comfort and Noticeability at Day 10 | 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: 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 |
| Participant Assessment of Symptom Intensity at Day 5 | 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. |
Countries
Germany
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
105 screened, 60 underwent ultraviolet (UV) rays induction, 25 developed a cold sore and were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. Baseline measures were determined for Safety population. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Acyclovir Patch | Placebo Patch | Total |
|---|---|---|---|
| Age, Continuous | 47.6 Years STANDARD_DEVIATION 14.88 | 43.2 Years STANDARD_DEVIATION 15.6 | 45.3 Years STANDARD_DEVIATION 15.11 |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 3 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
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.
Time frame: Baseline to Day 10
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Acyclovir Patch | Mean Change From Baseline in Blood Flow | TEV (Day 1 to Day 10) | 2558.65 Perfusion Units | Standard Error 627.87 |
| Acyclovir Patch | Mean Change From Baseline in Blood Flow | MEV | 809.88 Perfusion Units | Standard Error 127.93 |
| Placebo Patch | Mean Change From Baseline in Blood Flow | TEV (Day 1 to Day 10) | 3470.13 Perfusion Units | Standard Error 603.23 |
| Placebo Patch | Mean Change From Baseline in Blood Flow | MEV | 960.86 Perfusion Units | Standard Error 122.91 |
Comparison: Null hypothesis considered no difference between study treatments for TEV.p-value: 0.306195% CI: [-2712.65, 889.69]ANOVA
Comparison: Null hypothesis considered no difference between treatments for MEV.p-value: 0.403595% CI: [-517.97, 215.99]ANOVA
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).
Time frame: Baseline to Day 10
Population: ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Acyclovir Patch | Mean Change From Baseline in Color Intensity of Lesions | TEV | 11.05 Units on a scale | Standard Error 1.12 |
| Acyclovir Patch | Mean Change From Baseline in Color Intensity of Lesions | MEV | 2.66 Units on a scale | Standard Error 0.22 |
| Placebo Patch | Mean Change From Baseline in Color Intensity of Lesions | TEV | 8.91 Units on a scale | Standard Error 1.07 |
| Placebo Patch | Mean Change From Baseline in Color Intensity of Lesions | MEV | 2.29 Units on a scale | Standard Error 0.21 |
Comparison: Null hypothesis considered no difference between study treatments for TEV.p-value: 0.17995% CI: [-1.06, 5.35]ANOVA
Comparison: Null hypothesis considered no difference between study treatments for MEV.p-value: 0.244695% CI: [-0.27, 1]ANOVA
Primary
Mean Change From Baseline in Temperature
Lesion thermographic parameters for TEV and MEV were analysed.
Time frame: Baseline to Day 10
Population: ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Acyclovir Patch | Mean Change From Baseline in Temperature | TEV (Day 1 to Day 10) | 3.24 Degree celsius | Standard Error 0.86 |
| Acyclovir Patch | Mean Change From Baseline in Temperature | MEV | 0.90 Degree celsius | Standard Error 0.15 |
| Placebo Patch | Mean Change From Baseline in Temperature | TEV (Day 1 to Day 10) | 0.76 Degree celsius | Standard Error 0.82 |
| Placebo Patch | Mean Change From Baseline in Temperature | MEV | 0.51 Degree celsius | Standard Error 0.15 |
Comparison: Null hypothesis considered no difference between study treatments for TEV (Day 1 to day 10).p-value: 0.048695% CI: [0.02, 4.93]ANOVA
Comparison: Null hypothesis considered no difference between study treatments for MEV.p-value: 0.079995% CI: [-0.05, 0.82]ANOVA
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: 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
Time frame: Day 10
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Facial Movements (n= 4, 7) | 1.50 Units on a scale | Standard Deviation 1 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Ease of application (n= 4, 7) | 4.75 Units on a scale | Standard Deviation 0.5 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Cold Sore Coverage (n= 4, 7) | 4.75 Units on a scale | Standard Deviation 0.5 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Bothersomeness (n= 4, 7) | 1.50 Units on a scale | Standard Deviation 1 |
| Acyclovir Patch | 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 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Adhesiveness (n= 4, 7) | 4.75 Units on a scale | Standard Deviation 0.5 |
| Acyclovir Patch | 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 |
| Acyclovir Patch | 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 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Protection (n= 4, 7) | 4.50 Units on a scale | Standard Deviation 1 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Patch removal (n = 3, 5) | 4.60 Units on a scale | Standard Deviation 0.89 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Protection (n= 4, 7) | 4.14 Units on a scale | Standard Deviation 1.07 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Facial Movements (n= 4, 7) | 2.29 Units on a scale | Standard Deviation 1.11 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Interpersonal Interaction (n= 4, 7) | 1.14 Units on a scale | Standard Deviation 0.38 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Cold Sore Coverage (n= 4, 7) | 4.57 Units on a scale | Standard Deviation 0.54 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Cold sore appearance (n= 4, 7) | 1.14 Units on a scale | Standard Deviation 0.38 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Ease of application (n= 4, 7) | 4.86 Units on a scale | Standard Deviation 0.38 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Bothersomeness (n= 4, 7) | 2.43 Units on a scale | Standard Deviation 1.4 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 10 | Adhesiveness (n= 4, 7) | 3.86 Units on a scale | Standard Deviation 1.35 |
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: 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
Time frame: Day 5
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acyclovir Patch | 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 |
| Acyclovir Patch | 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 |
| Acyclovir Patch | 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 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Bothersomeness (n = 11, 12) | 1.55 Units on a scale | Standard Deviation 0.93 |
| Acyclovir Patch | 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 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Adhesivenes (n = 11, 12) | 4.36 Units on a scale | Standard Deviation 0.92 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Protection (n = 11, 12) | 4.45 Units on a scale | Standard Deviation 0.69 |
| Acyclovir Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Patch removal (n = 9, 10) | 4.33 Units on a scale | Standard Deviation 1 |
| Acyclovir Patch | 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 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Patch removal (n = 9, 10) | 4.60 Units on a scale | Standard Deviation 0.52 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Facial Movements (n = 11, 12) | 2.75 Units on a scale | Standard Deviation 1.6 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Interpersonal Interaction (n = 11, 12) | 1.75 Units on a scale | Standard Deviation 0.97 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Cold Sore Cover (n = 11, 12) | 3.92 Units on a scale | Standard Deviation 1.31 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Cold sore appearance (n = 11, 12) | 1.67 Units on a scale | Standard Deviation 1.16 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Ease of application (n = 11, 12) | 4.00 Units on a scale | Standard Deviation 1.04 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Bothersomeness (n = 11, 12) | 1.55 Units on a scale | Standard Deviation 0.45 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Adhesivenes (n = 11, 12) | 3.75 Units on a scale | Standard Deviation 0.97 |
| Placebo Patch | Participant Assessment of Patch Comfort and Noticeability at Day 5 | Protection (n = 11, 12) | 4.17 Units on a scale | Standard Deviation 1.12 |
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.
Time frame: Day 10
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acyclovir Patch | Participant Assessment of Symptom Intensity at Day 10 | Pain/Soreness (n = 4, 7) | 1.00 Units on a scale | Standard Deviation 0 |
| Acyclovir Patch | Participant Assessment of Symptom Intensity at Day 10 | Itching (n = 4, 7) | 1.00 Units on a scale | Standard Deviation 0 |
| Acyclovir Patch | Participant Assessment of Symptom Intensity at Day 10 | Burning (n = 4, 7) | 1.00 Units on a scale | Standard Deviation 0 |
| Placebo Patch | Participant Assessment of Symptom Intensity at Day 10 | Pain/Soreness (n = 4, 7) | 1.29 Units on a scale | Standard Deviation 0.49 |
| Placebo Patch | Participant Assessment of Symptom Intensity at Day 10 | Itching (n = 4, 7) | 1.14 Units on a scale | Standard Deviation 0.38 |
| Placebo Patch | Participant Assessment of Symptom Intensity at Day 10 | Burning (n = 4, 7) | 1.00 Units on a scale | Standard Deviation 0 |
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.
Time frame: Day 5
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acyclovir Patch | Participant Assessment of Symptom Intensity at Day 5 | Pain/Soreness (n = 11, 12) | 1.55 Units on a scale | Standard Deviation 0.82 |
| Acyclovir Patch | Participant Assessment of Symptom Intensity at Day 5 | Itching (n = 11, 12) | 1.18 Units on a scale | Standard Deviation 0.41 |
| Acyclovir Patch | Participant Assessment of Symptom Intensity at Day 5 | Burning (n = 11, 12) | 1.36 Units on a scale | Standard Deviation 0.67 |
| Placebo Patch | Participant Assessment of Symptom Intensity at Day 5 | Pain/Soreness (n = 11, 12) | 1.75 Units on a scale | Standard Deviation 1.22 |
| Placebo Patch | Participant Assessment of Symptom Intensity at Day 5 | Itching (n = 11, 12) | 1.67 Units on a scale | Standard Deviation 0.99 |
| Placebo Patch | Participant Assessment of Symptom Intensity at Day 5 | Burning (n = 11, 12) | 1.42 Units on a scale | Standard Deviation 0.67 |