Fucidin® Cream in the Treatment of Impetigo

Phase 4TerminatedNCT00986856

LEO Pharma58 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Impetigo

Interventions

Fucidin® creamDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Locations (2)

Institute of Internal Medicin, Haukeland University Hospital

Bergen, Norway

Vårdcentrum Kungshöjd

Gothenburg, Sweden

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

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

Data from ClinicalTrials.gov

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