CTRI/2026/07/114016Active, not recruitingUnknown
A Prospective, Multicentric, Randomized, Assessor-Blind, Parallel-Group Clinical Study to Compare the Efficacy and Safety of Topical Ozenoxacin 1 percent Cream versus Topical Mupirocin 2 percent Cream in Pediatric Patients with Impetigo. - NIL
Interventions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Indoco Remedies Limited
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •1.Pediatric patients of either gender aged 2 months to 12 years both inclusive.
- •2.Patients with a clinical diagnosis of impetigo as assessed by the investigator.
- •3.Patients with a Skin Infection Rating Scale SIRS score of 3 or more at screening or baseline.
- •4.Patients with an affected lesion area between 2 square centimetres and 100 square centimetres and involving not more than 2 percent of the body surface area.
- •5.Patients whose impetigo lesions are considered suitable for topical antibacterial therapy.
- •6.Parent or legal guardian willing to provide written informed consent. Oral assent will be obtained from patients aged 7 to 11 years. Written assent will be obtained from patients aged 12 years wherever applicable.
Exclusion Criteria
- •1.Patients with systemic spread of infection or clinical features requiring systemic antibacterial therapy.
- •2.Patients with other pyodermas or skin conditions that may interfere with assessment of impetigo lesions.
- •3.Immunosuppressed patients or patients with diabetes mellitus.
- •4.Patients who have used topical or systemic antibiotics within 4 weeks before screening or baseline.
- •5.Patients with known hypersensitivity or allergy to ozenoxacin, mupirocin, topical formulations, or any component of the study medications.
- •6.Patients who have participated in another clinical trial within 3 months before screening.
- •7.Patients with any severe concomitant illness that, in the opinion of the investigator, may interfere with study participation or assessment of study outcomes.
- •8.Any other condition for which the investigator considers the patient unsuitable for participation in the study.
Arms & Interventions
Intervention1: Topical Ozenoxacin 1 Percent Cream: As per the approved label, a thin layer will be applied to the affected area twice daily
Intervention: Intervention1: Topical Ozenoxacin 1 Percent Cream: As per the approved label, a thin layer will be applied to the affected area twice daily
Investigators
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