Fucidin® Cream in the Treatment of Impetigo
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.
|Study Design:||Allocation: Randomized
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|
- 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 ]
- 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.
|Study Start Date:||May 2004|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
|Experimental: Fucidin® cream||Drug: Fucidin® cream|
|Placebo Comparator: Fucidin® cream vehicle||Drug: Fucidin® cream|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986856
|Institute of Internal Medicin, Haukeland University Hospital|
|Bergen, Norway, 5021|
|Göteborg, Sweden, 411 19|
|Principal Investigator:||Inga Odenholt, MD, PhD||Skane University Hospital|