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

August 10, 2018 updated by: LEO Pharma

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

773

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Division of Dermatology, Groote Schuur Hospital, G23
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Anniston Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated informed consent from patient and/or legally acceptable representative has been obtained
  • Outpatients of any sex or ethnic origin
  • Patients >= 2 years of age (depending on study step)
  • Patients must be suffering from primary bullous/non-bullous impetigo or SITL

Exclusion Criteria:

  • Presence of skin diseases at or near the investigational area
  • Immunosuppressed state or other serious systemic disease
  • Signs and/or symptoms of systemic infection
  • Presence of skin infection/disorder not amenable to topical antibacterial treatment only
  • Presence of secondarily-infected animal/human bite
  • Presence of secondarily infected burnwound
  • Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs
  • Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream
  • Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream
  • Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation
  • Patients previously enrolled/randomised in this study
  • Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
BID 7 days
TID 7 days
EXPERIMENTAL: 2
BID 7 days
TID 7 days
ACTIVE_COMPARATOR: 3
BID 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Clinical Cure According to Investigator's Assessment
Time Frame: At end of treatment (Day 8)

At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.

Investigator's assessment of severity of infections (SIRS).

  • Exudates/pus
  • Crusting
  • Erythema
  • Oedema
  • Tissue Warmth
  • Itching
  • Pain

Each sign/symptoms of infection was assessed by use of the following 4-point scale:

  • 0 = absent
  • 2 = mild
  • 4 = moderate
  • 6 = severe

The scores were summed up to a total SIRS score.

Clinical cure was either of the following:

  • Total absence of signs and symptoms of impetigo/SITL OR
  • Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4.

Clinical failure was either of the following:

  • Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure
  • Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
At end of treatment (Day 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Clinical Cure According to Investigator's Assessment
Time Frame: At follow up (Day 15)
At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
At follow up (Day 15)
Participants With Clinical Cure According to Investigator's Assessment.
Time Frame: At end of treatment (Day 8) and follow-up (Day 15)
At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
At end of treatment (Day 8) and follow-up (Day 15)
Participants With Bacteriological Cure According to Bacteriological Samples
Time Frame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up

At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.

Bacteriological cure was either of the following:

  • Eradication of the baseline pathogen.
  • Presumed eradication of the baseline pathogen
  • Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.

Bacteriological failure was any of the following:

  • Documented lack of eradication of the baseline pathogen.
  • Documented relapse (re-infection) with the baseline pathogen
  • Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic
  • Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
Time Frame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up

At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.

At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based.

At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Participants With Clinical Cure According to Investigator's Assessment
Time Frame: At Day 4
At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.
At Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Almena L Free, MD, Anniston Medical Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (ESTIMATE)

February 29, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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