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Completed

NCT Number: NCT01653509

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

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.

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Key information

Conditions

Herpes Labialis DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

proDERM Institute for Applied Dermatological Research GmbH

Hamburg, 22869, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acyclovir patch

Device

Patch containing acyclovir

Placebo Patch

Device

Patch without acyclovir

Primary outcomes

  1. 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.

  2. Mean Change From Baseline in Temperature

    Time frame: Baseline to Day 10

    Lesion thermographic parameters for TEV and MEV were analysed.

  3. 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).

Secondary outcomes

  1. 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:

    • Today my sore felt completely protected
    • Today my cold sores interfered with facial movements such as smiling, eating or drinking
    • Today my cold sores interfered with my interaction with other people
    • Today the patch disguised my cold sores
    • Today I was bothered by the appearance of my cold sores
    • Today my patch was easy to apply
    • Today the patch covering my cold sores was bothersome
    • Today the patches stayed in place on my cold sores until I removed them
    • Today the patches were easy to remove from my lip or skin

  2. 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:

    • Today my sore felt completely protected
    • Today my cold sores interfered with facial movements such as smiling, eating or drinking
    • Today my cold sores interfered with my interaction with other people
    • Today the patch disguised my cold sores
    • Today I was bothered by the appearance of my cold sores
    • Today my patch was easy to apply
    • Today the patch covering my cold sores was bothersome
    • Today the patches stayed in place on my cold sores until I removed them
    • Today the patches were easy to remove from my lip or skin

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Labtec GmbH

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2012
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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