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Fucidin® Cream in the Treatment of Impetigo

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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:

Study Description
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

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
Primary Completion Date : March 2005
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

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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

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
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

Additional Information:
Responsible Party: Pontus Hegardt, Clinical Trial Manager, LEO Pharma
ClinicalTrials.gov Identifier: NCT00986856     History of Changes
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:
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
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action