NCT01653509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 10, 2014

Completed
Last Updated

July 16, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

July 19, 2012

Results QC Date

September 5, 2013

Last Update Submit

July 10, 2014

Conditions

Herpes Labialis

Keywords

cold sore

Outcome Measures

Primary Outcomes (3)

  • Mean Change From Baseline in Blood Flow

    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.

    Baseline to Day 10

  • Mean Change From Baseline in Temperature

    Lesion thermographic parameters for TEV and MEV were analysed.

    Baseline to Day 10

  • Mean Change From Baseline in Color Intensity of Lesions

    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).

    Baseline to Day 10

Secondary Outcomes (4)

  • 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

Study Arms (2)

Test patch

EXPERIMENTAL

Patch containing acyclovir applied to cold sore

Device: Acyclovir patch

Placebo patch

PLACEBO COMPARATOR

Patch without acyclovir applied to cold sore

Device: Placebo patch

Interventions

Acyclovir patchDEVICE

Patch containing acyclovir

Test patch
Placebo patchDEVICE

Patch without acyclovir

Placebo patch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

proDERM Institute for Applied Dermatological Research GmbH

Hamburg, 22869, Germany

Location

Related Publications (1)

  • Veltri J, Boon R, Bohling A, Wilhelm KP, Bielfeldt S. A Randomized Exploratory Study to Investigate the Inflammatory Response During an Ultraviolet-Radiation-Induced Cold Sore Episode. Dermatol Ther (Heidelb). 2021 Jun;11(3):983-994. doi: 10.1007/s13555-021-00531-x. Epub 2021 Apr 28.

    PMID: 33913104DERIVED

MeSH Terms

Conditions

Herpes Labialis

Condition Hierarchy (Ancestors)

Herpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralLip DiseasesMouth DiseasesStomatognathic DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

The study was not formally powered to detect statistically significant differences, but to provide information for methods development and develop sample size calculation for future studies.

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 16, 2014

Results First Posted

March 10, 2014

Record last verified: 2014-02

Locations

DE(1)