A clinical comparison of ozenoxacin 1% versus mupirocin 2% in the treatment of different types of skin infections
- Conditions
- Health Condition 1: L010- Impetigo
- Registration Number
- CTRI/2023/04/051498
- Lead Sponsor
- Department of Pharmacology, IPGMER and SSKM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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
Total affected area exceeding 100 square cm for adults and 2% body surface area for patients aged <12 years
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of subject showing at least 50% reduction in SIRS scoreTimepoint: 7 days
- Secondary Outcome Measures
Name Time Method safety and tolerability of ozenoxacin in terms of treatment emergent adverse eventsTimepoint: 7 days