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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: May 2, 2013
Last verified: November 2012
History of Changes
  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 2

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:

MedlinePlus related topics: Cold Sores
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline in blood flux in lesion area [ Time Frame: Baseline to Day 10 ] [ Designated as safety issue: No ]

    Measurement of lesion capillary 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 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. For each participant, the colour intensity values at Axis A and Axis B were plotted versus Day as the third dimension.

  • Mean change from baseline in temperature of lesion area [ Time Frame: Baseline to Day 10 ] [ Designated as safety issue: No ]
    Measurement of lesion heat, secondary to inflammation was performed using thermography camera. Thermographic parameters at TEV and MEV was analysed.


Secondary Outcome Measures:
  • Participant assessment of patch comfort and cold sore noticeability [ 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).

  • Participant assessment of Symptom intensity [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Cold sore symptoms (pain, burning, itching) assessment was performed using 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
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
Last Updated: May 2, 2013
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by GlaxoSmithKline:
cold sore

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

ClinicalTrials.gov processed this record on May 19, 2013