CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 773 enrolled
Drug / intervention
TD1414 2% cream +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00626795
NCT00626795Phase 2Completed

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

LEO Pharma·interventional·Posted Feb 29, 2008·Updated Mar 12, 2025

In Brief

A Phase 2 clinical trial evaluating TD1414 2% cream and Bactroban® (mupirocin) 2% cream for Impetigo and Secondarily Infected Traumatic Lesions. Completed, enrolled 773 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 29, 2008
Enrollment StartFeb 1, 2008
Primary CompletionMar 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.3 years ago

Interventions

TD1414 2% creamdrug

BID 7 days

TD1414 2% creamdrug

TID 7 days

Bactroban® (mupirocin) 2% creamdrug

BID 7 days