Trials Sponsors Conditions Drugs Pricing

Conditions

Impetigo

Outcome Measures

Primary Outcomes (1)

Clinical cure at EOF – Visit 4 measured as the proportion of subjects with clinical cure based on SIRS according to the blinded assessor.

Secondary Outcomes (7)

Clinical cure at EOT – Visit 3 measured as the proportion of subjects with clinical cure based on SIRS according to the blinded assessor.
Clinical cure at EOT and EOF measured as the proportion of subjects with clinical cure based on SIRS according to the investigator.
Total SIRS scores at EOT and EOF according to the blinded assessor.
Total SIRS scores at EOT and EOF according to the investigator.
Bacteriological cure at EOF.
+2 more secondary outcomes

Interventions

Impetine® 20mg/g GelType not reported

Bactroban 20 mg/g pomadaType 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
Impetine® 20mg/g Gel
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
GEL
View registry record
Formulated product
Bactroban 20 mg/g pomada
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
OINTMENT
View registry record

Ingredients named in source formulations

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

Impetine® 20mg/g Gel
Named ingredient: Mupirocin
View registry record
Bactroban 20 mg/g pomada
Named ingredient: Mupirocin
View registry record

Eligibility Criteria

Sexall

Age GroupsChild (0-17)

You may qualify if:

Clinical diagnosis of bullous or non-bullous impetigo.
Impetigo treatable with topical antibiotic in monotherapy.
Male and female aged between 18 months and 15 years old (inclusive) at the time of signing consent form.

Sponsors & Collaborators

Laboratorios Ojer Pharma S.L.
Industrylead

Study Sites (29)

CS Ansoáin

Ansoáin, 31013, Spain

Jorge Álvarez García+34636322857 jorge.alvarez.garcia@navarra.es

CAP Nueva Andalucía

Almería, 04004, Spain

Joanna Martínez Moya+34685204402 joannamartinezpediatra@gmail.com

Centro de Salud Nicolás Salmerón

Almería, 04002, Spain

Cristina Castro Abad+34696379494

Central Study Contacts

Clinical Development Manager

34948281776 pojer@ojerpharma.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

March 20, 2025

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: 2024-517475-20-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:43:22 UTC

Documents

D1_OP-IPTC02_Protocol_2024-517475-20-00_Clean_Redacted

Clinical trial to evaluate the efficacy and safety of the topical application of Impetine® Gel (mupirocin 20 mg/g) compared with Bactroban® Ointment (mupirocin 20 mg/g) for the treatment of impetigo in paediatric population.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

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 (7)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations