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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cold Sore

Intervention / Treatment
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* Drug: Penciclovir
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Penciclovir<br>Penciclovir | Drug: Penciclovir<br>* Penciclovir every 2 hours during waking hours for 96 hours<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo every 2 hous during waking hours for 96 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cold sore