A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cold Sore
Intervention: Penciclovir (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Philip Lamey, Principal Investigator, Affiliation: Principal Investigator
Overall contact:
Philip Lamey, Phone: 44 (0) 2890263035
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.
Clinical Details
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
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: Clinical assessment for:Prodrome,Macule,Papule,Vesicle,Crusted,Healed
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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;
Locations and Contacts
Philip Lamey, Phone: 44 (0) 2890263035
Belfast Health and Social Care Trust, Royal Victoria Hospital, Belfast BT12 6BA, United Kingdom; Recruiting
Philip Lamey
Philip Lamey, Principal Investigator
Additional Information
Starting date: December 2008
Ending date: March 2010
Last updated: August 10, 2009
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