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

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

• Status: Completed
• Conditions: Cold Sore
• Intervention / Treatment: Drug: Penciclovir; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo every 2 hous during waking hours for 96 hours
Experimental: Penciclovir	Drug: Penciclovir; Penciclovir every 2 hours during waking hours for 96 hours

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.	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).	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Principal Investigator: Philip Lamey, Principal Investigator

Study record dates

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: cold sore
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Lip Diseases; Herpes Simplex; Herpes Labialis; Anti-Infective Agents; Antiviral Agents; Penciclovir
• Other Study ID Numbers: FPP4-DE-401