NCT00626795

Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 773 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.

Conditions

• Impetigo
• Secondarily Infected Traumatic Lesions

Interventions

Type	Name	Description
DRUG	TD1414 2% cream	BID 7 days
DRUG	TD1414 2% cream	TID 7 days
DRUG	Bactroban® (mupirocin) 2% cream	BID 7 days

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-03-01
• Completion: 2009-06-01
• First posted: 2008-02-29
• Last updated: 2025-03-12
• Results posted: 2018-07-23

Locations

2 sites across 2 countries: United States, South Africa