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

NCT ID: NCT00820534

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-11-30

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.

Conditions

Cold Sore

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Penciclovir

Penciclovir

Group Type: EXPERIMENTAL

Penciclovir

Intervention Type: DRUG

Penciclovir every 2 hours during waking hours for 96 hours

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo every 2 hous during waking hours for 96 hours

Interventions

Penciclovir

Penciclovir every 2 hours during waking hours for 96 hours

Intervention Type: DRUG

Placebo

Placebo every 2 hous during waking hours for 96 hours

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Lamey

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Belfast Health and Social Care Trust, Royal Victoria Hospital

Belfast, , United Kingdom

Countries

United Kingdom

Other Identifiers

FPP4-DE-401

Identifier Type: -

Identifier Source: org_study_id