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

Herpes Labialis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653509
• Other study ID #: E7411153
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2012
• Last updated: July 10, 2014
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: February 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Labialis

Intervention

Device:
• Acyclovir patch
Patch containing acyclovir
• Placebo patch
Patch without acyclovir

Locations

Country	Name	City	State
Germany	proDERM Institute for Applied Dermatological Research GmbH	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Labtec GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Blood Flow	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.	Baseline to Day 10	No
Primary	Mean Change From Baseline in Temperature	Lesion thermographic parameters for TEV and MEV were analysed.	Baseline to Day 10	No
Primary	Mean Change From Baseline in Color Intensity of Lesions	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).	Baseline to Day 10	No
Secondary	Participant Assessment of Patch Comfort and Noticeability at 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	Day 5	No
Secondary	Participant Assessment of Patch Comfort and Noticeability at 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	Day 10	No
Secondary	Participant Assessment of Symptom Intensity at 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.	Day 5	No
Secondary	Participant Assessment of Symptom Intensity at 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.	Day 10	No