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:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

skin temperature measured by thermography; the number and proportion of patients who have negative thermographic assessments at 72 hours will be compared between the active and vehicle groups. [ Time Frame: Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical assessment for:Prodrome,Macule,Papule,Vesicle,Crusted,Healed [ Time Frame: Time Frame: 72 hours ] [ Designated as safety issue: No ]

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
Penciclovir: Experimental Penciclovir	Drug: Penciclovir Penciclovir every 2 hours during waking hours for 96 hours
Placebo: Placebo Comparator 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:	Belfast Health and Social Care Trust Royal Victoria Hospital ( Prof Philip Lamey )
Study ID Numbers:	FPP4-DE-401
Study First Received:	January 9, 2009
Last Updated:	December 2, 2009
ClinicalTrials.gov Identifier:	NCT00820534 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

cold sore

Additional relevant MeSH terms:

Herpes Simplex
Mouth Diseases
Anti-Infective Agents
Skin Diseases
Lip Diseases
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Therapeutic Uses
Penciclovir
DNA Virus Infections
Stomatognathic Diseases
Herpes Labialis

ClinicalTrials.gov processed this record on February 04, 2010