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
  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:


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
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, see Learn About Clinical Studies.

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 July 24, 2014