Back to resultsA Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Primary Purpose
Cold Sore
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Penciclovir
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cold Sore focused on measuring cold sore
Eligibility Criteria
Inclusion Criteria:
- Be known to be a cold sore sufferer and presenting a prodromal stage with pain
- Sign the written informed consent form prior to enrolment in the trial;
- Be aged 18 to 75 years;
Exclusion Criteria:
- If female, are pregnant, planning pregnancy or lactating;
- Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
- Have already ongoing classical cold sore lesions at the baseline visit;
- Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
- Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
- Are known to be immunosuppressed (acquired, congenital or therapeutic);
- Have been involved in any investigational protocol within the 30 days prior to the trial;
- Have evidence or history of drug or alcohol abuse;
Sites / Locations
- Belfast Health and Social Care Trust, Royal Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Penciclovir
Placebo
Arm Description
Penciclovir
Placebo
Outcomes
Primary Outcome Measures
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).
Secondary Outcome Measures
Size of the Cold Sore
The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00820534
Brief Title
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Official Title
A Randomised, Double-blind, Vehicle Controlled, Single Center, Parallel Group, Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Sore
Keywords
cold sore
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Penciclovir
Arm Type
Experimental
Arm Description
Penciclovir
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Penciclovir
Intervention Description
Penciclovir every 2 hours during waking hours for 96 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo every 2 hous during waking hours for 96 hours
Primary Outcome Measure Information:
Title
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
Description
Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Size of the Cold Sore
Description
The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be known to be a cold sore sufferer and presenting a prodromal stage with pain
Sign the written informed consent form prior to enrolment in the trial;
Be aged 18 to 75 years;
Exclusion Criteria:
If female, are pregnant, planning pregnancy or lactating;
Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
Have already ongoing classical cold sore lesions at the baseline visit;
Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
Are known to be immunosuppressed (acquired, congenital or therapeutic);
Have been involved in any investigational protocol within the 30 days prior to the trial;
Have evidence or history of drug or alcohol abuse;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Lamey
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belfast Health and Social Care Trust, Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
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