Status:
COMPLETED
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Lead Sponsor:
Novartis
Conditions:
Cold Sore
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 sensat...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00820534
Start Date
December 1 2008
End Date
November 1 2009
Last Update
April 20 2012
Active Locations (1)
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1
Belfast Health and Social Care Trust, Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA