An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Labialis
Intervention: Acyclovir patch (Device); Placebo patch (Device)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Change From Baseline in Blood FlowMean Change From Baseline in Temperature Mean Change From Baseline in Color Intensity of Lesions
Secondary outcome: Participant Assessment of Patch Comfort and Noticeability at Day 5Participant Assessment of Patch Comfort and Noticeability at Day 10 Participant Assessment of Symptom Intensity at Day 5 Participant Assessment of Symptom Intensity at Day 10
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet
(UV) light
Locations and Contacts
proDERM Institute for Applied Dermatological Research GmbH, Hamburg 22869, Germany
Additional Information
Starting date: July 2012
Last updated: July 10, 2014
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