- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00986856
Fucidin® Cream in the Treatment of Impetigo
A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fucidin® cream
|
|
Placebo Comparator: Fucidin® cream vehicle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
EOT: Visit at Day 25
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Clinical Success at Visit 2
Time Frame: Visit 2: Day 4
|
Visit 2: Day 4
|
|
Number of Patients With Clinical Success at Visit 3
Time Frame: Visit 3: Day 11
|
Visit 3: Day 11
|
|
Number of Patients With Clinical Success at EOT
Time Frame: EOT: Visit at day 25
|
EOT: Visit at day 25
|
|
Number of Patients With Bacteriological Success at Visit 2
Time Frame: Visit 2: Day 4
|
Visit 2: Day 4
|
|
Number of Patients With Bacteriological Success at Visit 3
Time Frame: Visit 3: Day 11
|
Visit 3: Day 11
|
|
Number of Patients With Bacteriological Success at EOT
Time Frame: EOT: Visit at day 25
|
EOT: Visit at day 25
|
|
The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).
Time Frame: EOT: Visit at day 25
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Inga Odenholt, MD, PhD, Skane University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Skin Diseases, Infectious
- Staphylococcal Infections
- Skin Diseases, Bacterial
- Staphylococcal Skin Infections
- Impetigo
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Fusidic Acid
Other Study ID Numbers
- FUC 0301 INT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Impetigo
-
Lytix Biopharma ASCompletedNon-bullous ImpetigoDominican Republic
-
GlaxoSmithKlineCompletedImpetigoIndia, Mexico, Netherlands, Italy, Peru
-
Ferrer Internacional S.A.Completed
-
Philippine Dermatological SocietySt. Luke's Medical CenterUnknown
-
NovaBay Pharmaceuticals, Inc.Novum Pharmaceutical Research Services; International Dermatology Research,...Completed
-
NovaBay Pharmaceuticals, Inc.CompletedImpetigoUnited States, South Africa
-
UNION therapeuticsCompleted
-
Ferrer Internacional S.A.CompletedEfficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With ImpetigoImpetigoGermany, South Africa
Clinical Trials on Fucidin® cream
-
LEO PharmaTerminated
-
Shanghai Zhongshan HospitalRecruiting
-
KK Women's and Children's HospitalNot yet recruiting
-
Loreal USACompleted
-
Pharmanutra S.p.a.NEA Clinical S.r.l.Active, not recruitingAnkle Injury or Chronic Trauma to the AnkleGeorgia, Italy
-
University of Roma La SapienzaCompleted
-
Dermavant Sciences, Inc.Completed
-
LEO PharmaCompletedPsoriasis VulgarisCanada
-
Galderma R&DCompletedAcne VulgarisUnited States, Canada, France
-
ACO Hud Nordic ABThe University of Sheffield Medical SchoolCompletedDermatitis, AtopicUnited Kingdom