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Multicenter, randomized, open-label with blind evaluation, non-inferiority clinical trial, with parallel groups to evaluate the efficacy and safety of the topical application of Impetine® Gel (mupirocin 20 mg/g, Gel) compared with Bactroban® (mupirocin 20 mg/g, Ointment) for the treatment of impetigo in paediatric population

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517475-20-00
Acronym
OP-IPTC02
Enrollment
464
Registered
2025-06-27
Start date
2025-10-13
Completion date
Unknown
Last updated
2025-06-27

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

Conditions

Impetigo

Brief summary

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

Detailed description

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., Treatment satisfaction at EOT., Incidence of adverse events.

Interventions

DRUGImpetine® 20mg/g Gel
DRUGBactroban 20 mg/g pomada

Sponsors

Laboratorios Ojer Pharma S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

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

Secondary

MeasureTime frame
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., Treatment satisfaction at EOT., Incidence of adverse events.—

Countries

Spain

Outcome results

None listed

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