Status:
COMPLETED
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
Lead Sponsor:
EMS
Conditions:
Herpes Labialis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Herpe...
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, vesic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01257074
Start Date
February 1 2012
End Date
October 1 2012
Last Update
March 4 2013
Active Locations (1)
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1
Flavia Addor
São Paulo, São Paulo, Brazil