Health Condition 1: L010- Impetigo
Conditions
Interventions
Intervention1: Topical Ozenoxacin 1 Percent Cream: As per the approved label, a thin layer will be applied to the affected area twice daily
(BID) for a total duration of 5 days.
Control Intervention1:
Sponsors
Indoco Remedies Limited
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving clinical success defined as clinical cure or clinical improvement based on Skin Infection Rating Scale score. Timepoint: At Day 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and proportion of patients reporting adverse events.Timepoint: Up to Day 6/Visit 3 End of Study.;Number and proportion of patients reporting serious adverse events.Timepoint: Up to Day 6/Visit 3 End of Study.;Number and proportion of patients withdrawn due to adverse events.Timepoint: Up to Day 6/Visit 3 End of Study.;Proportion of patients achieving clinical cure.Timepoint: At Day 3 and Day 6.;Proportion of patients achieving clinical improvement.Timepoint: At Day 3 and Day 6.;Proportion of patients with clinical failure.Timepoint: At Day 3 and Day 6.;Mean change in total Skin Infection Rating Scale SIRS score from baseline in the two treatment groups.Timepoint: At Day 3 and Day 6.;Proportion of patients requiring additional antibacterial therapy during the study period.Timepoint: From baseline until Day 6. | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Indoco Remedies Limited
Outcome results
None listed