TerminatedPhase 4

Fucidin® Cream in the Treatment of Impetigo

Stopped: Enrollment failed

Norway, Sweden58 participantsStarted 2004-05

Plain-language 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.

Who can participate

Age range2 Years – 11 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).

Timeframe: EOT: Visit at Day 25

Trial details

NCT IDNCT00986856

SponsorLEO Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-03

Results submitted2010-03-19

View on ClinicalTrials.gov More Impetigo trials