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

Phase 3

Completed

• Conditions: Herpes Labialis
• Interventions: Drug: Penciclovir 10mg/g; Drug: Acyclovir 50mg/g

• Registration Number: NCT01257074
• Lead Sponsor: EMS

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Study Start: 2012-02
• Primary Completion: 2012-03
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. 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;
3. No history of reaction to topical products;

Exclusion Criteria

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
4. Sunlight over exposure in the last 15 days.
5. Any pathology or past medical condition that can interfere with this protocol.
6. AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);
7. Patients with immunodeficiency and/or immunosuppressive disease;
8. Sunlight exposure in the last 15 days;
9. Hypersensitivity to components of the formula;
10. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug 1	Penciclovir 10mg/g	Penciclovir 10mg/g
Drug 2	Acyclovir 50mg/g	Acyclovir 50mg/g

Primary Outcome Measures

Name	Time	Method
Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation	Day 10	Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Day 10

Trial Locations

Locations (1)

Flavia Addor; 🇧🇷 São Paulo, Brazil