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

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

Sponsors

Lead Sponsor: Novartis

Source Novartis
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.

Overall Status Completed
Start Date 2008-12-01
Completion Date 2009-11-01
Primary Completion Date 2009-11-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. 72 hours
Secondary Outcome
Measure Time Frame
Size of the Cold Sore 72 hours
Enrollment 126
Condition
Intervention

Intervention Type: Drug

Intervention Name: Penciclovir

Description: Penciclovir every 2 hours during waking hours for 96 hours

Arm Group Label: Penciclovir

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo every 2 hous during waking hours for 96 hours

Arm Group Label: Placebo

Eligibility

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;

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Philip Lamey Principal Investigator Principal Investigator
Location
Facility: Belfast Health and Social Care Trust, Royal Victoria Hospital
Location Countries

United Kingdom

Verification Date

2010-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Penciclovir

Type: Experimental

Description: Penciclovir

Label: Placebo

Type: Placebo Comparator

Description: Placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

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