Trials Sponsors Conditions Drugs Pricing

Conditions

Recurrent herpes labialis (RHL)

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

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

Interventions

Lipovir 50 mg/g GelType not reported

Zovirax 50 mg/g cremaType not reported

PlaceboType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Lipovir 50 mg/g Gel
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
GEL
View registry record
Formulated product
Zovirax 50 mg/g crema
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CREAM
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Lipovir 50 mg/g Gel
Named ingredient: Aciclovir
View registry record
Zovirax 50 mg/g crema
Named ingredient: Aciclovir
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants must have at least 3 recurrences or herpes labialis within the past year.
At least half of the recurrences are preceded by recognizable prodromal symptoms, e.g., itching, redness, burning, tingling or a sense of irritation.

Sponsors & Collaborators

Laboratorios Ojer Pharma S.L.
Industrylead

Study Sites (10)

Synexus Polska Sp. z o.o.

Poznan, 60-702, Poland

Grzegorz Konieczny+48736259739 grzegorz.konieczny3@trialmed.com

Synexus Polska Sp. z o.o.

Gdynia, 81-537, Poland

Agnieszka Cegielska+48691751071 agnieszka.cegielska@trialmed.com

Synexus Polska Sp. z o.o.

Gdansk, 80-382, Poland

Joanna Renczynska-Matysko+48587129970

Central Study Contacts

Clinical Development Manager

34948281776 pojer@ojerpharma.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

June 12, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-510338-10-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-29 06:36:04 UTC

Documents

D1_Protocol_2023-510338-10-00_FP

Clinical trial to investigate the efficacy and tolerability of Lipovir® Gel (Acyclovir 5%) compared to Zovirax® Cream (Acyclovir 5%) and placebo on patients with recurrent herpes labialis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations