Last updated: 11/04/2018 06:13:13
An exploratory study to investigate the inflammatory response during a cold sore episode
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An exploratory study to investigate the inflammatory response during a cold sore episode
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in blood flow
Timeframe: Baseline to Day 10
Mean change from baseline in temperature
Timeframe: Baseline to Day 10
Mean change from baseline in color intensity of lesions
Timeframe: Baseline to Day 10
Secondary outcomes:
Participant assessment of patch comfort and noticeability at Day 5
Timeframe: Day 5
Participant assessment of patch comfort and noticeability at Day 10
Timeframe: Day 10
Participant assessment of Symptom intensity at Day 5
Timeframe: Day 5
Participant assessment of Symptom intensity at Day 10
Timeframe: Day 10
Interventions:
Device: Acyclovir patch
Device: Placebo patch
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
2012-30-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Labialis
Product
Acyclovir
Collaborators
Labtec GmbH
Study date(s)
July 2012 to September 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
Inclusion and exclusion criteria
Inclusion criteria:
- Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
Trial location(s)
Location
proDERM Institute for Applied Dermatological Research GmbH
Hamburg, Not Available, Germany, 22869
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-30-09
Actual study completion date
2012-30-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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