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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

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ClinicalTrials.gov Identifier: NCT00820534
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : January 19, 2011
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE January 9, 2009
First Posted Date  ICMJE January 12, 2009
Results First Submitted Date  ICMJE November 12, 2010
Results First Posted Date  ICMJE January 19, 2011
Last Update Posted Date April 20, 2012
Study Start Date  ICMJE December 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
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 ]
Change History Complete list of historical versions of study NCT00820534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
Clinical assessment for:Prodrome,Macule,Papule,Vesicle,Crusted,Healed [ Time Frame: Time Frame: 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Cold Sore
Intervention  ICMJE
  • Drug: Penciclovir
    Penciclovir every 2 hours during waking hours for 96 hours
  • Drug: Placebo
    Placebo every 2 hous during waking hours for 96 hours
Study Arms  ICMJE
  • Experimental: Penciclovir
    Penciclovir
    Intervention: Drug: Penciclovir
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2009)
126
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
140
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00820534
Other Study ID Numbers  ICMJE FPP4-DE-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Lamey Principal Investigator
PRS Account Novartis
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP