CompletedPhase 3

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

Brazil76 participantsStarted 2012-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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;

What they're measuring

Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation

Timeframe: Day 10

Trial details

NCT IDNCT01257074

SponsorEMS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03

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