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Fucidin® Cream in the Treatment of Impetigo A phase IV study comparing clinical and bacteriological efficacy of Fucidin® cream with Fucidin® cream vehicle in the treatment of impetigo in paediatric patients

Fucidin® Cream in the Treatment of Impetigo A phase IV study comparing clinical and bacteriological efficacy of Fucidin® cream with Fucidin® cream vehicle in the treatment of impetigo in paediatric patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002687-14-GB
Enrollment
360
Registered
2005-02-17
Start date
2004-11-15
Completion date
Unknown
Last updated
2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a clinical diagnosis of impetigo, aged 2-11 years, with a severity score of minimum 1 for at least one of the following signs: Pustules/infected bullae, erythema and infiltration/induration. MedDRA version: 6.1 Level: PT Classification code 10021531

Interventions

Trade Name: Fucidin® Cream Pharmaceutical Form: Cream INN or Proposed INN: Fusidic Acid CAS Number: 3990-06-3 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number:

Sponsors

LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with a clinical diagnosis of impetigo, aged 2-11 years, of either sex, whose parent(s) has(ve) provided written consent, and with a severity score of minimum 1 for at least one of the following signs: Pustules/infected bullae, erythema and infiltration/induration. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with other active inflammatory dermatitis at the area of impetigo, a temperature above 38.5 degrees C rectally (or equivalent), patients who have been administered topical or systemic Fucidin® or other antibacterial agents within the previous 4 weeks.

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo. ;Secondary Objective: 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. ;Primary end point(s): The proportion of patients with clinical and bacteriological success at end of treatment. Clinical success is defined as ‘marked improvement’ or ‘completely cleared’ according to Investigators’ Overall Efficacy Assessment. Bacteriological success is defined as eradication of S. aureus and beta-haemolytic streptococci (group A) from the target lesion.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026