NCT04287777

Safety and Efficacy of Mupirocin Gel in Children With Impetigo

Ph-III Randomized, Multicentric, Controlled , Non-inferiority Trial to Evaluate the Safety and Efficacy of Mupirocin Gel 20 mg/g Versus Mupirocin Ointment 20 mg/g and Placebo in the Treatment of Impetigo in Paediatric Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 467 (actual)
• Sponsor: Reig Jofre Group · Industry
• Sex: All
• Age: 18 Months – 15 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	Placebo	Topical administration of Placebo (ointment) TID during 7 days

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2020-02-27
• Last updated: 2021-03-12

Locations

20 sites across 1 country: Spain