Fucidin® Cream in the Treatment of Impetigo

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Impetigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fucidin® cream

Group Type EXPERIMENTAL

Fucidin® cream

Intervention Type DRUG

Fucidin® cream vehicle

Group Type PLACEBO_COMPARATOR

Fucidin® cream

Intervention Type DRUG

Interventions

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Fucidin® cream

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No