MedTrace Logo

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

NCT00626795 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 773

Last updated 2025-03-12

Study results available
· View outcomes & findings →

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

DRUG

TD1414 2% cream

BID 7 days

DRUG

TD1414 2% cream

TID 7 days

DRUG

Bactroban® (mupirocin) 2% cream

BID 7 days

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Almena L Free, MD · Anniston Medical Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-03-31
Completion
2009-06-30

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626795 on ClinicalTrials.gov