Fucidin® Cream in the Treatment of Impetigo

This study has been terminated.

(Enrollment failed)

Sponsor:

Information provided by:

LEO Pharma

ClinicalTrials.gov Identifier:

NCT00986856

First received: September 29, 2009

Last updated: October 19, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 29, 2009

Last Updated Date

October 19, 2010

Start Date ^ICMJE

May 2004

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT). [ Time Frame: EOT: Visit at Day 25 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The proportion of patients with clinical success (marked improvement or completely cleared) and bacteriological success (eradication) at end of treatment (EOT).

Change History

Complete list of historical versions of study NCT00986856 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Patients With Clinical Success at Visit 2 [ Time Frame: Visit 2: Day 4 ] [ Designated as safety issue: No ]
Number of Patients With Clinical Success at Visit 3 [ Time Frame: Visit 3: Day 11 ] [ Designated as safety issue: No ]
Number of Patients With Clinical Success at EOT [ Time Frame: EOT: Visit at day 25 ] [ Designated as safety issue: No ]
Number of Patients With Bacteriological Success at Visit 2 [ Time Frame: Visit 2: Day 4 ] [ Designated as safety issue: No ]
Number of Patients With Bacteriological Success at Visit 3 [ Time Frame: Visit 3: Day 11 ] [ Designated as safety issue: No ]
Number of Patients With Bacteriological Success at EOT [ Time Frame: EOT: Visit at day 25 ] [ Designated as safety issue: No ]
The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF). [ Time Frame: EOT: Visit at day 25 ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

The proportion of patients with: clinical and bacteriological success at visit 2, 3 and at EOT.
The actual change in Total Severity Score from baseline to end of treatment.
The distribution of individual sign scores at end of treatment.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fucidin® Cream in the Treatment of Impetigo

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Impetigo

Intervention ^ICMJE

Drug: Fucidin® cream

Study Arm (s)

Experimental: Fucidin® cream
Intervention: Drug: Fucidin® cream
Placebo Comparator: Fucidin® cream vehicle
Intervention: Drug: Fucidin® cream

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

2 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00986856

Other Study ID Numbers ^ICMJE

FUC 0301 INT

Has Data Monitoring Committee

Responsible Party

Pontus Hegardt, Clinical Trial Manager, LEO Pharma

Study Sponsor ^ICMJE

LEO Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Inga Odenholt, MD, PhD

Skane University Hospital

Information Provided By

LEO Pharma

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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