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Fucidin® Cream in the Treatment of Impetigo

Primary Purpose

Impetigo

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Fucidin® cream

About this trial

This is an interventional treatment trial for Impetigo

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Institute of Internal Medicin, Haukeland University Hospital
Vårdcentrum Kungshöjd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fucidin® cream

Fucidin® cream vehicle

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Patients With Clinical Success at Visit 2

Number of Patients With Clinical Success at Visit 3

Number of Patients With Clinical Success at EOT

Number of Patients With Bacteriological Success at Visit 2

Number of Patients With Bacteriological Success at Visit 3

Number of Patients With Bacteriological Success at EOT

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.

Full Information

NCT ID

NCT00986856

First Posted

September 29, 2009

Last Updated

March 25, 2015

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00986856

Brief Title

Fucidin® Cream in the Treatment of Impetigo

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Terminated

Why Stopped

Enrollment failed

Study Start Date

May 2004 (undefined)

Primary Completion Date

March 2005 (Actual)

Study Completion Date

March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impetigo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fucidin® cream

Arm Type

Experimental

Arm Title

Fucidin® cream vehicle

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Fucidin® cream

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Number of Patients With Clinical Success at Visit 2

Time Frame

Visit 2: Day 4

Title

Number of Patients With Clinical Success at Visit 3

Time Frame

Visit 3: Day 11

Title

Number of Patients With Clinical Success at EOT

Time Frame

EOT: Visit at day 25

Title

Number of Patients With Bacteriological Success at Visit 2

Time Frame

Visit 2: Day 4

Title

Number of Patients With Bacteriological Success at Visit 3

Time Frame

Visit 3: Day 11

Title

Number of Patients With Bacteriological Success at EOT

Time Frame

EOT: Visit at day 25

Title

The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).

Description

Time Frame

EOT: Visit at day 25

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Inga Odenholt, MD, PhD

Organizational Affiliation

Skane University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Internal Medicin, Haukeland University Hospital

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Vårdcentrum Kungshöjd

City

Göteborg

ZIP/Postal Code

411 19

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Fucidin® Cream in the Treatment of Impetigo

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