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

July 10, 2014 updated by: GlaxoSmithKline
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22869
        • proDERM Institute for Applied Dermatological Research GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test patch
Patch containing acyclovir applied to cold sore
Device: Acyclovir patch
Patch containing acyclovir
Placebo Comparator: Placebo patch
Patch without acyclovir applied to cold sore
Device: Placebo patch
Patch without acyclovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Day 10
Mean Change From Baseline in Temperature
Time Frame: Baseline to Day 10
Lesion thermographic parameters for TEV and MEV were analysed.
Baseline to Day 10
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).
Baseline to Day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Assessment of Patch Comfort and Noticeability at Day 5
Time Frame: Day 5

Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:

  1. Today my sore felt completely protected
  2. Today my cold sores interfered with facial movements such as smiling, eating or drinking
  3. Today my cold sores interfered with my interaction with other people
  4. Today the patch disguised my cold sores
  5. Today I was bothered by the appearance of my cold sores
  6. Today my patch was easy to apply
  7. Today the patch covering my cold sores was bothersome
  8. Today the patches stayed in place on my cold sores until I removed them
  9. Today the patches were easy to remove from my lip or skin
Day 5
Participant Assessment of Patch Comfort and Noticeability at Day 10
Time Frame: Day 10

Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:

  1. Today my sore felt completely protected
  2. Today my cold sores interfered with facial movements such as smiling, eating or drinking
  3. Today my cold sores interfered with my interaction with other people
  4. Today the patch disguised my cold sores
  5. Today I was bothered by the appearance of my cold sores
  6. Today my patch was easy to apply
  7. Today the patch covering my cold sores was bothersome
  8. Today the patches stayed in place on my cold sores until I removed them
  9. Today the patches were easy to remove from my lip or skin
Day 10
Participant Assessment of Symptom Intensity at Day 5
Time Frame: Day 5
Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time.
Day 5
Participant Assessment of Symptom Intensity at Day 10
Time Frame: Day 10
Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time.
Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Labtec GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7411153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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