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Fucidin® Cream in the Treatment of Impetigo

This study has been terminated.
(Enrollment failed)
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00986856
First received: September 29, 2009
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Impetigo
 Drug: Fucidin® cream
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Impetigo
U.S. FDA Resources

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients With Clinical Success at Visit 2 [ Time Frame: Visit 2: Day 4 ] [ Designated as safety issue: No ]
  • Number of Patients With Clinical Success at Visit 3 [ Time Frame: Visit 3: Day 11 ] [ Designated as safety issue: No ]
  • Number of Patients With Clinical Success at EOT [ Time Frame: EOT: Visit at day 25 ] [ Designated as safety issue: No ]
  • Number of Patients With Bacteriological Success at Visit 2 [ Time Frame: Visit 2: Day 4 ] [ Designated as safety issue: No ]
  • Number of Patients With Bacteriological Success at Visit 3 [ Time Frame: Visit 3: Day 11 ] [ Designated as safety issue: No ]
  • Number of Patients With Bacteriological Success at EOT [ Time Frame: EOT: Visit at day 25 ] [ Designated as safety issue: No ]
  • The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF). [ Time Frame: EOT: Visit at day 25 ] [ Designated as safety issue: No ]
    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.


Enrollment: 58
Study Start Date: May 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fucidin® cream Drug: Fucidin® cream
Placebo Comparator: Fucidin® cream vehicle Drug: Fucidin® cream

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986856

Locations
Norway
Institute of Internal Medicin, Haukeland University Hospital
Bergen, Norway, 5021
Sweden
Vårdcentrum Kungshöjd
Göteborg, Sweden, 411 19
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Inga Odenholt, MD, PhD Skane University Hospital
  More Information

No publications provided

Responsible Party: Pontus Hegardt, Clinical Trial Manager, LEO Pharma
ClinicalTrials.gov Identifier: NCT00986856     History of Changes
Other Study ID Numbers: FUC 0301 INT
Study First Received: September 29, 2009
Results First Received: March 19, 2010
Last Updated: October 19, 2010
Health Authority: Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
 Skin Diseases
Fusidic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013