Fucidin® Cream in the Treatment of Impetigo

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients

Conditions
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Impetigo

Intervention / Treatment
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* Drug: Fucidin® cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fucidin® cream<br> | Drug: Fucidin® cream<br> <br> |
| Placebo Comparator: Fucidin® cream vehicle<br> | Drug: Fucidin® cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |