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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 Flow

Mean 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 5

Participant 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

Page last updated: August 23, 2015

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