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

This study has been completed.
Sponsor:
Collaborator:
Labtec GmbH
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01653509
First received: July 19, 2012
Last updated: July 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Herpes Labialis
Device: Acyclovir patch
Device: Placebo patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline in Blood Flow [ Time Frame: Baseline to Day 10 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Lesion thermographic parameters for TEV and MEV were analysed.

  • Mean Change From Baseline in Color Intensity of Lesions [ Time Frame: Baseline to Day 10 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Participant Assessment of Patch Comfort and Noticeability at Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653509

Locations
Germany
proDERM Institute for Applied Dermatological Research GmbH
Hamburg, Germany, 22869
Sponsors and Collaborators
GlaxoSmithKline
Labtec GmbH
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01653509     History of Changes
Other Study ID Numbers: E7411153
Study First Received: July 19, 2012
Results First Received: September 5, 2013
Last Updated: July 10, 2014
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by GlaxoSmithKline:
cold sore

Additional relevant MeSH terms:
Herpes Labialis
DNA Virus Infections
Herpes Simplex
Herpesviridae Infections
Lip Diseases
Mouth Diseases
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Stomatognathic Diseases
Virus Diseases
Acyclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014