NCT04155203

To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions

Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Mupirocin Cream to A Reference Manufacturer's Mupirocin Cream and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: Padagis LLC · Industry
• Sex: All
• Age: 18 Months
• Healthy volunteers: Not accepted

Summary

To compare the safety and efficacy of Perrigo's product to an FDA approved product, and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions

Conditions

• Secondarily Infected Traumatic Skin Lesions

Interventions

Type	Name	Description
DRUG	Mupirocin Calcium	mupirocin cream
DRUG	Mupirocin Calcium	Reference mupirocin cream
DRUG	Vehicle	vehicle control cream

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-11-07
• Last updated: 2022-11-03
• Results posted: 2022-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study