Fucidin® Cream in the Treatment of Impetigo

NCT00986856 | Terminated Phase 4 Results

• 1 other identifier: FUC 0301 INT
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 2

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.

Conditions

Impetigo

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Number of Patients With Clinical Success at Visit 2

  Visit 2: Day 4

• Number of Patients With Clinical Success at Visit 3

  Visit 3: Day 11

• Number of Patients With Clinical Success at EOT

  EOT: Visit at day 25

• Number of Patients With Bacteriological Success at Visit 2

  Visit 2: Day 4

• Number of Patients With Bacteriological Success at Visit 3

  Visit 3: Day 11

Study Arms (2)

Fucidin® cream

EXPERIMENTAL

Drug: Fucidin® cream

Fucidin® cream vehicle

PLACEBO COMPARATOR

Drug: Fucidin® cream

Interventions

Fucidin® cream DRUG

Fucidin® cream; Fucidin® cream vehicle

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Institute of Internal Medicin, Haukeland University Hospital

Bergen, 5021, Norway

Location

Vårdcentrum Kungshöjd

Gothenburg, 411 19, Sweden

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Impetigo

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

It was planned to Incl. 360 Pts(Proport.3:1 Fucidin® cream:Fucidin® cream vehicle), but due to very slow recruitment in SE and N and inability to Incl. UK, only 59 Pts were enrolled. 58 Pts were randomised: 42Fucidin® cream:16 Fucidin® cream vehicle.

Results Point of Contact

• Title: Anders Rhod Larsen, Scientific advisor
• Organization: LEO Pharma

anders.larsen@leo-pharma.com

+45 72262990

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: May 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: March 6, 2025
• Results First Posted: September 29, 2010

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); NO (1)