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

Indoco Remedies Limited0 个研究点目标入组 100 人开始时间: 2026年7月25日最近更新: 2026年8月3日

干预措施

试验速览

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•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.

•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.

干预措施: Intervention1: Topical Ozenoxacin 1 Percent Cream: As per the approved label, a thin layer will be applied to the affected area twice daily

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