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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fucidin® cream | Experimental |
| |
| Fucidin® cream vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fucidin® cream | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT). | EOT: Visit at Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinical Success at Visit 2 | Visit 2: Day 4 | |
| Number of Patients With Clinical Success at Visit 3 | Visit 3: Day 11 | |
| Number of Patients With Clinical Success at EOT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Internal Medicin, Haukeland University Hospital | Bergen | 5021 | Norway | |||
| Vårdcentrum Kungshöjd |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fucidin® Cream | Fucidin® cream 20 mg/g 3 times daily for 10 days |
| FG001 | Fucidin® Cream Vehicle | Fucidin® cream vehicle 3 times daily for 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fucidin® Cream | Fucidin® cream 20 mg/g 3 times daily for 10 days |
| BG001 | Fucidin® Cream Vehicle | Fucidin® cream vehicle 3 times daily for 10 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT). | The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline | Posted | Dec 2009 | Number | Participants | EOT: Visit at Day 25 |
|
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All 58 randomised patients comprised the safety analysis set except patients who: 1. did not provide any post randomisation safety data or 2. did not use any trial medication confirmed by return of all trial medication given to the patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fucidin® Cream | Fucidin® cream 20 mg/g 3 times daily for 10 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA | Systematic Assessment |
It was planned to Incl. 360 Pts(Proport.3:1 Fucidin® cream:Fucidin® cream vehicle), but due to very slow recruitment in SE and N and inability to Incl. UK, only 59 Pts were enrolled. 58 Pts were randomised: 42Fucidin® cream:16 Fucidin® cream vehicle.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anders Rhod Larsen, Scientific advisor | LEO Pharma | +45 72262990 | anders.larsen@leo-pharma.com |
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| ID | Term |
|---|---|
| D007169 | Impetigo |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| EOT: Visit at day 25 |
| Number of Patients With Bacteriological Success at Visit 2 | Visit 2: Day 4 |
| Number of Patients With Bacteriological Success at Visit 3 | Visit 3: Day 11 |
| Number of Patients With Bacteriological Success at EOT | EOT: Visit at day 25 |
| The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF). | 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. | EOT: Visit at day 25 |
| Gothenburg |
| 411 19 |
| Sweden |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| S.aureus susceptible to fusidic acid | Number | S. aureus |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Number of Patients With Clinical Success at Visit 2 | The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data) | Posted | Dec 2009 | Number | Participants | Visit 2: Day 4 |
|
|
|
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| Secondary | Number of Patients With Clinical Success at Visit 3 | The analysis population were those patients who had a visit 3 observation | Posted | Number | Participants | Visit 3: Day 11 |
|
|
|
|
| Secondary | Number of Patients With Clinical Success at EOT | The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data) | Posted | Number | Participants | EOT: Visit at day 25 |
|
|
|
|
| Secondary | Number of Patients With Bacteriological Success at Visit 2 | The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline | Posted | Dec 2009 | Number | Participants | Visit 2: Day 4 |
|
|
|
|
| Secondary | Number of Patients With Bacteriological Success at Visit 3 | The analysis population were those patients who had a visit 3 observation | Posted | Dec 2009 | Number | Participants | Visit 3: Day 11 |
|
|
|
|
| Secondary | Number of Patients With Bacteriological Success at EOT | The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline | Posted | Dec 2009 | Number | Participants | EOT: Visit at day 25 |
|
|
|
|
| Secondary | The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF). | 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. | The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data) | Posted | Dec 2009 | Mean | Standard Error | Units on a scale | EOT: Visit at day 25 |
|
|
|
|
| 0 |
| 40 |
| 5 |
| 40 |
| EG001 | Fucidin® Cream Vehicle | Fucidin® cream vehicle 3 times daily for 10 days | 0 | 16 | 4 | 16 |
| Infections and infestations | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infections and | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |