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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00820534
First Posted: January 12, 2009
Last Update Posted: April 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00820534     History of Changes
Other Study ID Numbers: FPP4-DE-401
First Submitted: January 9, 2009
First Posted: January 12, 2009
Results First Submitted: November 12, 2010
Results First Posted: January 19, 2011
Last Update Posted: April 20, 2012
Last Verified: December 2010

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