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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • 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.

  • Mean Change From Baseline in Temperature [ Time Frame: Baseline to Day 10 ]
    Lesion thermographic parameters for TEV and MEV were analysed.
  • 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).


Original Primary Outcome:

  • Blood Flux [ Time Frame: change from baseline inflammation at day 10 ]
    Measurement of lesion capillary blood flow
  • Colour intensity [ Time Frame: change from baseline inflammation at day 10 ]
    Measurement of lesion color secondary to inflammation
  • Thermography [ Time Frame: change from baseline inflammation at day 10 ]
    Measurement of lesion heat secondary to inflammation


Current Secondary Outcome:

  • 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
  • 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
  • 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.
  • 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.


Original Secondary Outcome:

  • Patch comfort [ Time Frame: change from baseline inflammation at day 10 ]
    Patch aesthetics on the cold sore using a 5-point scale
  • Symptom intensity [ Time Frame: change from baseline inflammation at day 10 ]
    Cold sore symptoms (pain, burning, itching) using a 5-point scale


Information By: GlaxoSmithKline

Dates:
Date Received: July 19, 2012
Date Started: July 2012
Date Completion:
Last Updated: July 10, 2014
Last Verified: February 2014