Multicenter, randomised, open-label with blind evaluation active and placebo-controlled, non-inferiority clinical trial to investigate the efficacy and tolerability of Lipovir® Gel (Acyclovir 5%) compared to Zovirax® Cream (Acyclovir 5%) on patients with Recurrent Herpes Labialis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510338-10-00

Acronym

OP-LIPC02

Enrollment

200

Registered

2024-10-07

Start date

2025-01-15

Completion date

Unknown

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent herpes labialis (RHL)

Brief summary

Duration of Episode (DOE) assessed by the investigator based on clinical observation and review of participant diary. For vesicular lesions, DOE is the time from treatment initiation to the healing (loss of crust; residual erythema may be present). For not vesicular lesions, DOE is the time from treatment initiation to the return to normal skin or to cessation of symptoms, whichever occurs last.

Detailed description

Local product tolerability self-reported by the participant, Product acceptability as assessed by the participant, Incidence of adverse events

Interventions

DRUGLipovir 50 mg/g Gel

DRUGZovirax 50 mg/g crema

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Duration of Episode (DOE) assessed by the investigator based on clinical observation and review of participant diary. For vesicular lesions, DOE is the time from treatment initiation to the healing (loss of crust; residual erythema may be present). For not vesicular lesions, DOE is the time from treatment initiation to the return to normal skin or to cessation of symptoms, whichever occurs last.	—

Secondary

Measure	Time frame
Local product tolerability self-reported by the participant, Product acceptability as assessed by the participant, Incidence of adverse events	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026