Fucidin® Cream in the Treatment of Impetigo

Impetigo Clinical Trial

Official title:

A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00986856
• Other study ID #: FUC 0301 INT
• Status: Terminated
• Phase: Phase 4
• First received: September 29, 2009
• Last updated: March 25, 2015
• Start date: May 2004
• Est. completion date: March 2005

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impetigo

Intervention

Drug:
• Fucidin® cream

Locations

Country	Name	City	State
Norway	Institute of Internal Medicin, Haukeland University Hospital	Bergen
Sweden	Vårdcentrum Kungshöjd	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).		EOT: Visit at Day 25	No
Secondary	Number of Patients With Clinical Success at Visit 2		Visit 2: Day 4	No
Secondary	Number of Patients With Clinical Success at Visit 3		Visit 3: Day 11	No
Secondary	Number of Patients With Clinical Success at EOT		EOT: Visit at day 25	No
Secondary	Number of Patients With Bacteriological Success at Visit 2		Visit 2: Day 4	No
Secondary	Number of Patients With Bacteriological Success at Visit 3		Visit 3: Day 11	No
Secondary	Number of Patients With Bacteriological Success at EOT		EOT: Visit at day 25	No
Secondary	The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).	Total Severity Score is the sum of scores for the following 5 signs: Pustules/infected bullae, erythema, infiltration/induration, erosions and crusting. Each sign is assessed using a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe involvement. Minimum Total Severity score is 0, maximum score is 15.	EOT: Visit at day 25	No

External Links

•   Clinical Trials at LEO Pharma