Fucidin® Cream in the Treatment of Impetigo

March 25, 2015 updated by: LEO Pharma

A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients

To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients.

To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream.

To investigate the genetic relationship between S. aureus-strains isolated from impetigo patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

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

      • Bergen, Norway, 5021
        • Institute of Internal Medicin, Haukeland University Hospital
      • Göteborg, Sweden, 411 19
        • Vårdcentrum Kungshöjd

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 to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a clinical diagnosis of impetigo,
  • Patients aged 2-11 years,
  • Patients of either sex,
  • Patients whose parent(s) has(ve) provided written consent, AND
  • Patients with a severity score of 1 for at least one of the following signs: pustules/infected bullae, erythema and infiltration/induration.

Exclusion Criteria:

  • Patients with other active inflammatory dermatitis at the area of impetigo,
  • Patients with a temperature above 38.5 C rectally (or equivalent), OR
  • Patients who have been administered topical or systemic Fucidin® or other antibacterial agents within the previous 4 weeks.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fucidin® cream
Placebo Comparator: Fucidin® cream vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
Time Frame: EOT: Visit at Day 25
EOT: Visit at Day 25

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Clinical Success at Visit 2
Time Frame: Visit 2: Day 4
Visit 2: Day 4
Number of Patients With Clinical Success at Visit 3
Time Frame: Visit 3: Day 11
Visit 3: Day 11
Number of Patients With Clinical Success at EOT
Time Frame: EOT: Visit at day 25
EOT: Visit at day 25
Number of Patients With Bacteriological Success at Visit 2
Time Frame: Visit 2: Day 4
Visit 2: Day 4
Number of Patients With Bacteriological Success at Visit 3
Time Frame: Visit 3: Day 11
Visit 3: Day 11
Number of Patients With Bacteriological Success at EOT
Time Frame: EOT: Visit at day 25
EOT: Visit at day 25
The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).
Time Frame: EOT: Visit at day 25
Total Severity Score is the sum of scores for the following 5 signs: Pustules/infected bullae, erythema, infiltration/induration, erosions and crusting. Each sign is assessed using a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe involvement. Minimum Total Severity score is 0, maximum score is 15.
EOT: Visit at day 25

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Inga Odenholt, MD, PhD, Skane University Hospital

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

May 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

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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