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

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

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.