Fucidin® Cream in the Treatment of Impetigo

Phase 4

Terminated

• Conditions: Impetigo
• Interventions: Drug: Fucidin® cream

• Registration Number: NCT00986856
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Results First Submitted: 2010-03-19
• Results First Submitted QC: 2010-09-07
• Results First Posted: 2010-09-29
• Status Verified: 2015-03
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fucidin® cream	Fucidin® cream	-
Fucidin® cream vehicle	Fucidin® cream	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 3	Visit 3: Day 11
Number of Patients With Clinical Success at Visit 2	Visit 2: Day 4
Number of Patients With Bacteriological Success at Visit 2	Visit 2: Day 4

Trial Locations

Locations (2)

Vårdcentrum Kungshöjd; 🇸🇪 Göteborg, Sweden

Institute of Internal Medicin, Haukeland University Hospital; 🇳🇴 Bergen, Norway