Skip to main content
OpenTrials
Completed

NCT Number: NCT00820534

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cold Sore DNA Virus Infections Herpes Labialis Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Belfast Health and Social Care Trust, Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Penciclovir

Drug

Penciclovir every 2 hours during waking hours for 96 hours

Placebo

Drug

Placebo every 2 hous during waking hours for 96 hours

Primary outcomes

  1. Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.

    Time frame: 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 outcomes

  1. Size of the Cold Sore

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2009
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.