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

Novartis

Status and phase

Completed

Phase 4

Conditions

Cold Sore

Treatments

Drug: Penciclovir

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00820534

FPP4-DE-401

Details and patient eligibility

About

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.

Enrollment

126 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;