Safety and Efficacy of Mupirocin Gel in Children With Impetigo
NCT04287777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 467
Last updated 2021-03-12
Summary
The purpose of the study is to show non inferiority in terms of safety and efficacy of topical administration BID (Twice daily) of Mupirocin Gel 20 mg/g compared to topical administration of Mupirocin Ointment 20 mg/g TID (three times daily) (Bactroban) in the treatment of impetigo in paediatric population.
Conditions
- Impetigo
Interventions
- DRUG
-
Mupirocin gel
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
- DRUG
-
Mupirocin ointment
Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
- DRUG
-
Topical administration of Placebo (ointment) TID during 7 days
Sponsors & Collaborators
-
Reig Jofre Group
lead INDUSTRY
Principal Investigators
-
Raúl De Lucas, Dr. · Hospital La Paz
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Months
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2016-11-30
- Completion
- 2016-11-30
Countries
- Spain
Study Locations
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