We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fucidin® Cream in the Treatment of Impetigo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00986856
Recruitment Status : Terminated (Enrollment failed)
First Posted : September 30, 2009
Results First Posted : September 29, 2010
Last Update Posted : April 14, 2015
Sponsor:
Information provided by:
LEO Pharma

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Impetigo Drug: Fucidin® cream Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients
Study Start Date : May 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Fucidin® cream Drug: Fucidin® cream
Placebo Comparator: Fucidin® cream vehicle Drug: Fucidin® cream


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of Patients With Clinical Success at Visit 2 [ Time Frame: Visit 2: Day 4 ]
  2. Number of Patients With Clinical Success at Visit 3 [ Time Frame: Visit 3: Day 11 ]
  3. Number of Patients With Clinical Success at EOT [ Time Frame: EOT: Visit at day 25 ]
  4. Number of Patients With Bacteriological Success at Visit 2 [ Time Frame: Visit 2: Day 4 ]
  5. Number of Patients With Bacteriological Success at Visit 3 [ Time Frame: Visit 3: Day 11 ]
  6. Number of Patients With Bacteriological Success at EOT [ Time Frame: EOT: Visit at day 25 ]
  7. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986856


Locations
Layout table for location information
Norway
Institute of Internal Medicin, Haukeland University Hospital
Bergen, Norway, 5021
Sweden
Vårdcentrum Kungshöjd
Göteborg, Sweden, 411 19
Sponsors and Collaborators
LEO Pharma
Investigators
Layout table for investigator information
Principal Investigator: Inga Odenholt, MD, PhD Skane University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Pontus Hegardt, Clinical Trial Manager, LEO Pharma
ClinicalTrials.gov Identifier: NCT00986856    
Other Study ID Numbers: FUC 0301 INT
First Posted: September 30, 2009    Key Record Dates
Results First Posted: September 29, 2010
Last Update Posted: April 14, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Streptococcal Infections
Skin Diseases, Bacterial
 Skin Diseases, Infectious
Skin Diseases
Fusidic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action