Clinical Trial: Fucidin® Cream in the Treatment of Impetigo

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Patient

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.


Detailed Summary:
Sponsor: LEO Pharma

Current Primary Outcome: 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 ]

Original Primary Outcome: The proportion of patients with clinical success (marked improvement or completely cleared) and bacteriological success (eradication) at end of treatment (EOT).

Current Secondary Outcome:

  • Number of Patients With Clinical Success at Visit 2 [ Time Frame: Visit 2: Day 4 ]
  • Number of Patients With Clinical Success at Visit 3 [ Time Frame: Visit 3: Day 11 ]
  • Number of Patients With Clinical Success at EOT [ Time Frame: EOT: Visit at day 25 ]
  • Number of Patients With Bacteriological Success at Visit 2 [ Time Frame: Visit 2: Day 4 ]
  • Number of Patients With Bacteriological Success at Visit 3 [ Time Frame: Visit 3: Day 11 ]
  • Number of Patients With Bacteriological Success at EOT [ Time Frame: 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.


Original Secondary Outcome:

  • The proportion of patients with: clinical and bacteriological success at visit 2, 3 and at EOT.
  • The actual change in Total Severity Score from baseline to end of treatment.
  • The distribution of individual sign scores at end of treatment.


Information By: LEO Pharma

Dates:
Date Received: September 29, 2009
Date Started: May 2004
Date Completion:
Last Updated: March 25, 2015
Last Verified: March 2015