Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis

Study Overview
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Brief Summary
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Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g.

Detailed Description
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Study design: • Double blinded non-inferiority prospective parallel-group, intend to treat trial. Study design: Experiment duration: 10 days 3 visits (days 1,5 and 10) Erythema, papule, vesicle, ulcer, crust and healed skin evaluation Adverse events evaluation

Official Title
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A Randomized, Double-Blind, to Compare Non-inferiority Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis.

Conditions
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Herpes Labialis

Intervention / Treatment
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* Drug: Acyclovir 50mg/g
* Drug: Penciclovir 10mg/g


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be able to understand the study procedures agree to participate and give written consent. Patients with clinical diagnosis of recurrent herpes labialis and are in the prodromal period (stinging, itching, burning and erythema) at the onset of signs / symptoms in the last 12-24 hours; No history of reaction to topical products; Exclusion Criteria: Pregnancy or risk of pregnancy. Lactation Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.) Sunlight over exposure in the last 15 days. Any pathology or past medical condition that can interfere with this protocol. AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study); Patients with immunodeficiency and/or immunosuppressive disease; Sunlight exposure in the last 15 days; Hypersensitivity to components of the formula; Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug 1<br>Penciclovir 10mg/g | Drug: Penciclovir 10mg/g<br>* Cream, dose 5 times daily during 5 days<br>|
| Active Comparator: Drug 2<br>Acyclovir 50mg/g | Drug: Acyclovir 50mg/g<br>* Cream, dose 5 times daily during 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation | Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin. | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes Simplex