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

Phase 1

Completed

• Conditions: Herpes Labialis
• Interventions: Device: Acyclovir patch; Device: Placebo patch

• Registration Number: NCT01653509
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-31
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2013-09-05
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-06
• Results First Posted: 2014-03-10
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test patch	Acyclovir patch	Patch containing acyclovir applied to cold sore
Placebo patch	Placebo patch	Patch without acyclovir applied to cold sore

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

proDERM Institute for Applied Dermatological Research GmbH; 🇩🇪 Hamburg, Germany