An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Blood Flow
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
Exclusion Criteria
- Not provided
Arms & Interventions
Test patch
Patch containing acyclovir applied to cold sore
Intervention: Acyclovir patch (Device)
Placebo patch
Patch without acyclovir applied to cold sore
Intervention: Placebo patch (Device)
Outcomes
Primary Outcomes
Mean Change From Baseline in Blood Flow
Time Frame: 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
Time Frame: Baseline to Day 10
Lesion thermographic parameters for TEV and MEV were analysed.
Mean Change From Baseline in Color Intensity of Lesions
Time Frame: 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 Outcomes
- Participant Assessment of Patch Comfort and Noticeability at Day 5(Day 5)
- Participant Assessment of Patch Comfort and Noticeability at Day 10(Day 10)
- Participant Assessment of Symptom Intensity at Day 5(Day 5)
- Participant Assessment of Symptom Intensity at Day 10(Day 10)