Fucidin® Cream in the Treatment of Impetigo

LEO Pharma

Status and phase: Terminated; Phase 4

Conditions: Impetigo

Treatments: Drug: Fucidin® cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00986856

FUC 0301 INT

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

Fucidin® cream

Experimental group

Treatment:

Drug: Fucidin® cream

Fucidin® cream vehicle

Placebo Comparator group

Treatment:

Drug: Fucidin® cream