Impetigo
Conditions
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.
Interventions
DRUGFucidin® cream
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Bacteriological Success at EOT | EOT: Visit at day 25 | — |
| 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 3 | Visit 3: Day 11 | — |
| Number of Patients With Clinical Success at Visit 2 | Visit 2: Day 4 | — |
| The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF). | 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. |
| Number of Patients With Bacteriological Success at Visit 2 | Visit 2: Day 4 | — |
Countries
Norway, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fucidin® Cream Fucidin® cream 20 mg/g 3 times daily for 10 days | 42 |
| Fucidin® Cream Vehicle Fucidin® cream vehicle 3 times daily for 10 days | 16 |
| Total | 58 |
Baseline characteristics
| Characteristic | Fucidin® Cream | Fucidin® Cream Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 42 Participants | 16 Participants | 58 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.8 years STANDARD_DEVIATION 2.7 | 6.3 years STANDARD_DEVIATION 2.9 | 5.2 years STANDARD_DEVIATION 2.8 |
| Region of Enrollment Norway | 10 participants | 1 participants | 11 participants |
| Region of Enrollment Sweden | 32 participants | 15 participants | 47 participants |
| S.aureus susceptible to fusidic acid No S. aureus isolated | 12 S. aureus | 4 S. aureus | 16 S. aureus |
| S.aureus susceptible to fusidic acid S. aureus resistant to fusidic acid | 18 S. aureus | 8 S. aureus | 26 S. aureus |
| S.aureus susceptible to fusidic acid S. aureus susceptible to fusidic acid | 12 S. aureus | 4 S. aureus | 16 S. aureus |
| Sex: Female, Male Female | 18 Participants | 8 Participants | 26 Participants |
| Sex: Female, Male Male | 24 Participants | 8 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 40 | 4 / 16 |
| serious Total, serious adverse events | 0 / 40 | 0 / 16 |
Outcome results
Primary
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
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fucidin® Cream | Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT). | Clinical and bacteriological success | 16 Participants |
| Fucidin® Cream | Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT). | Clinical and bacteriological failure | 17 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT). | Clinical and bacteriological success | 1 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT). | Clinical and bacteriological failure | 12 Participants |
p-value: <0.0195% CI: [1.4, 120.4]Cochran-Mantel-Haenszel
Secondary
Number of Patients With Bacteriological Success at EOT
Time frame: EOT: Visit at day 25
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fucidin® Cream | Number of Patients With Bacteriological Success at EOT | Success | 17 Participants |
| Fucidin® Cream | Number of Patients With Bacteriological Success at EOT | Failure | 16 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Bacteriological Success at EOT | Success | 1 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Bacteriological Success at EOT | Failure | 12 Participants |
p-value: 0.00795% CI: [1.5, 109.6]Cochran-Mantel-Haenszel
Secondary
Number of Patients With Bacteriological Success at Visit 2
Time frame: Visit 2: Day 4
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fucidin® Cream | Number of Patients With Bacteriological Success at Visit 2 | Success | 6 Participants |
| Fucidin® Cream | Number of Patients With Bacteriological Success at Visit 2 | Failure | 27 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Bacteriological Success at Visit 2 | Success | 0 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Bacteriological Success at Visit 2 | Failure | 13 Participants |
p-value: 0.1Cochran-Mantel-Haenszel
Secondary
Number of Patients With Bacteriological Success at Visit 3
Time frame: Visit 3: Day 11
Population: The analysis population were those patients who had a visit 3 observation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fucidin® Cream | Number of Patients With Bacteriological Success at Visit 3 | Success | 17 Participants |
| Fucidin® Cream | Number of Patients With Bacteriological Success at Visit 3 | Failure | 10 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Bacteriological Success at Visit 3 | Success | 1 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Bacteriological Success at Visit 3 | Failure | 5 Participants |
p-value: 0.04395% CI: [0.9, 83.5]Cochran-Mantel-Haenszel
Secondary
Number of Patients With Clinical Success at EOT
Time frame: EOT: Visit at day 25
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fucidin® Cream | Number of Patients With Clinical Success at EOT | Success | 27 Participants |
| Fucidin® Cream | Number of Patients With Clinical Success at EOT | Failure | 13 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Clinical Success at EOT | Success | 7 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Clinical Success at EOT | Failure | 9 Participants |
p-value: 0.195% CI: [0.8, 8.8]Cochran-Mantel-Haenszel
Secondary
Number of Patients With Clinical Success at Visit 2
Time frame: Visit 2: Day 4
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fucidin® Cream | Number of Patients With Clinical Success at Visit 2 | Failure | 22 Participants |
| Fucidin® Cream | Number of Patients With Clinical Success at Visit 2 | Success | 18 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Clinical Success at Visit 2 | Success | 2 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Clinical Success at Visit 2 | Failure | 14 Participants |
p-value: 0.02395% CI: [1.1, 28.6]Cochran-Mantel-Haenszel
Secondary
Number of Patients With Clinical Success at Visit 3
Time frame: Visit 3: Day 11
Population: The analysis population were those patients who had a visit 3 observation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fucidin® Cream | Number of Patients With Clinical Success at Visit 3 | Success | 27 Participants |
| Fucidin® Cream | Number of Patients With Clinical Success at Visit 3 | Failure | 7 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Clinical Success at Visit 3 | Failure | 3 Participants |
| Fucidin® Cream Vehicle | Number of Patients With Clinical Success at Visit 3 | Success | 7 Participants |
p-value: 0.5495% CI: [0.3, 8.1]Cochran-Mantel-Haenszel
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.
Time frame: EOT: Visit at day 25
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucidin® Cream | The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF). | -3.9 Units on a scale | Standard Error 3.5 |
| Fucidin® Cream Vehicle | The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF). | -1.2 Units on a scale | Standard Error 4.4 |
p-value: 0.00895% CI: [-4.8, -0.8]Regression, Linear