A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers

Phase 4

Completed

• Conditions: Cold Sore
• Interventions: Drug: Penciclovir; Drug: Placebo

• Registration Number: NCT00820534
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2010-11-12
• Status Verified: 2010-12
• Results First Submitted QC: 2010-12-16
• Results First Posted: 2011-01-19
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Penciclovir	Penciclovir	Penciclovir
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.	72 hours	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

Name	Time	Method
Size of the Cold Sore	72 hours	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.

Trial Locations

Locations (1)

Belfast Health and Social Care Trust, Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom