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

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: 6.1Level: PTClassification code 10021531

Registration Number: EUCTR2004-002687-14-GB

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 360

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures