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

Cold Sore Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820534
• Other study ID #: FPP4-DE-401
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2009
• Last updated: April 18, 2012
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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;

Study Design

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

Related Conditions & MeSH terms

• Cold Sore
• Herpes Labialis

Intervention

Drug:
• Penciclovir
Penciclovir every 2 hours during waking hours for 96 hours
• Placebo
Placebo every 2 hous during waking hours for 96 hours

Locations

Country	Name	City	State
United Kingdom	Belfast Health and Social Care Trust, Royal Victoria Hospital	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.	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).	72 hours	No
Secondary	Size of the Cold Sore	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.	72 hours	No