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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00820534

Purpose

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.

Condition	Intervention	Phase
Cold Sore	Drug: Penciclovir Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Cold Sores

Drug Information available for: Penciclovir Penciclovir sodium

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
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:

Size of the Cold Sore [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
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.

Enrollment:	126
Study Start Date:	December 2008
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Penciclovir Penciclovir	Drug: Penciclovir Penciclovir every 2 hours during waking hours for 96 hours
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo every 2 hous during waking hours for 96 hours

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820534

Locations

United Kingdom
Belfast Health and Social Care Trust, Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Philip Lamey

Principal Investigator

More Information

No publications provided

Responsible Party:	Prof Philip Lamey, Belfast Health and Social Care Trust Royal Victoria Hospital
ClinicalTrials.gov Identifier:	NCT00820534 History of Changes
Other Study ID Numbers:	FPP4-DE-401
Study First Received:	January 9, 2009
Results First Received:	November 12, 2010
Last Updated:	December 16, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

cold sore

Additional relevant MeSH terms:

Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases

Skin Diseases, Infectious
Skin Diseases
Penciclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012