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A clinical comparison of ozenoxacin 1% versus mupirocin 2% in the treatment of different types of skin infections

A randomized controlled trial of ozenoxacin 1% versus mupirocin 2% topical application in the treatment of impetigo and other uncomplicated skin infections

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051498
Enrollment
90
Registered
2023-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: L010- Impetigo

Interventions

Intervention1: ozenoxacin cream 1% w/w: drug to be applied 2 times daily for 7 days. For each application minimum one fingertip unit could be used(approximately 0.5g) over affected skin Control Interv

Sponsors

Department of Pharmacology, IPGMER and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with clinical diagnosis of impetigo and other uncomplicated skin infections Skin infection Rating Scale(SIRS)score of at least 4 Total affected area should be more than 1 square cm Patients agreeing to come for follow up visit after 7 days

Exclusion criteria

Exclusion criteria: Total affected area exceeding 100 square cm for adults and 2% body surface area for patients aged Concomitant treatment with drugs like antimicrobials, topical steroids and antiseptics, analgesics, immunosuppressants HIV, evidence of immunosuppression, uncontrolled diabetes hypersensitivity to both the drugs Pregnant, lactating patients Signs suggestive of systemic infection like sustained fever, nausea, vomiting, prostration Patients unwilling to give consent Lack of caregiver support Any other condition which in the opinion of investigator is not conducive to inclusion of the patient in the study

Design outcomes

Primary

MeasureTime frame
proportion of subject showing at least 50% reduction in SIRS scoreTimepoint: 7 days

Secondary

MeasureTime frame
safety and tolerability of ozenoxacin in terms of treatment emergent adverse eventsTimepoint: 7 days

Countries

India

Contacts

Public ContactSUKANYA DAS

IPGMER and SSKM Hospital Kolkata

subhrangsu27@gmail.com9748111442

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026