Fucidin® Cream in the Treatment of Impetigo
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
|Experimental: Fucidin® cream||Drug: Fucidin® cream|
|Placebo Comparator: Fucidin® cream vehicle||Drug: Fucidin® cream|
- 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.
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
|Institute of Internal Medicin, Haukeland University Hospital|
|Bergen, Norway, 5021|
|Göteborg, Sweden, 411 19|
|Principal Investigator:||Inga Odenholt, MD, PhD||Skane University Hospital|