Phase 1 N=25 Randomized Double-blind Treatment

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

Herpes Labialis

Bottom Line

View on ClinicalTrials.gov: NCT01653509 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Mean Change From Baseline in Blood Flow — 2558.65; 3470.13; 809.88; 960.86 Perfusion Units — p=0.3061

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Acyclovir patch (Device); Placebo patch (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Blood Flow	2558.65; 3470.13; 809.88; 960.86	0.3061
PRIMARY Mean Change From Baseline in Temperature	3.24; 0.76; 0.90; 0.51	0.0486 sig
PRIMARY Mean Change From Baseline in Color Intensity of Lesions	11.05; 8.91; 2.66; 2.29	0.1790
SECONDARY Participant Assessment of Patch Comfort and Noticeability at Day 5	4.45; 4.17; 2.18; 2.75; 2.09; 1.75	—
SECONDARY Participant Assessment of Patch Comfort and Noticeability at Day 10	4.50; 4.14; 1.50; 2.29; 1.50; 1.14	—
SECONDARY Participant Assessment of Symptom Intensity at Day 5	1.55; 1.75; 1.18; 1.67; 1.36; 1.42	—
SECONDARY Participant Assessment of Symptom Intensity at Day 10	1.00; 1.29; 1.00; 1.14; 1.00; 1.00	—

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.

Eligibility Criteria

Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01653509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.