- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00820534
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
April 18, 2012 updated by: Novartis
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belfast, United Kingdom, BT12 6BA
- Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Placebo every 2 hous during waking hours for 96 hours
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Experimental: Penciclovir
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Penciclovir every 2 hours during waking hours for 96 hours
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
Time Frame: 72 hours
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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).
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72 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Size of the Cold Sore
Time Frame: 72 hours
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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.
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72 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philip Lamey, Principal Investigator
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
January 9, 2009
First Submitted That Met QC Criteria
January 9, 2009
First Posted (Estimate)
January 12, 2009
Study Record Updates
Last Update Posted (Estimate)
April 20, 2012
Last Update Submitted That Met QC Criteria
April 18, 2012
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPP4-DE-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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