ImpetigoPhase 4NCT00986856
Fucidin® Cream in the Treatment of Impetigo
A Phase 4 study testing Fucidin® cream in people with Impetigo, run by LEO Pharma at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Impetigo
- What is being tested?
- Fucidin® cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2004to Mar 2005
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Norway1 site
Institute of Internal Medicin, Haukeland University Hospital
Bergen, 5021
About this study
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
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
- Being tested
- Fucidin® cream
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fucidin® creamDrug
| Study group | Role | What they receive |
|---|---|---|
| Fucidin® cream | Experimental | Not described Receives: Drug: Fucidin® cream |
| Fucidin® cream vehicle | Placebo comparator | Not described Receives: Drug: Fucidin® cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
Measured: EOT: Visit at Day 25
Secondary outcomes (7)
Number of Patients With Clinical Success at Visit 2
Measured: Visit 2: Day 4
Number of Patients With Clinical Success at Visit 3
Measured: Visit 3: Day 11
Number of Patients With Clinical Success at EOT
Measured: EOT: Visit at day 25
Number of Patients With Bacteriological Success at Visit 2
Measured: Visit 2: Day 4
Number of Patients With Bacteriological Success at Visit 3
Measured: Visit 3: Day 11
Number of Patients With Bacteriological Success at EOT
Measured: EOT: Visit at day 25
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.
Measured: EOT: Visit at day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startMay 2004
- Primary completionMar 2005
- Study completionMar 2005
Why it stopped: Enrollment failed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ImpetigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986856
- Sponsor's protocol ID
- FUC 0301 INT
- Status last verified
- Mar 2015
- First submitted
- 29 Sep 2009
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00986856
- Acronym / sponsor ID
- FUC 0301 INT
- Conditions
- Impetigo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment failed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Posted 29 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fucidin® cream | Experimental | Drug: Fucidin® cream |
| Fucidin® cream vehicle | Placebo comparator | Drug: Fucidin® cream |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fucidin® cream | Drug | Fucidin® cream, Fucidin® cream vehicle |
Primary outcome
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
7 secondary outcomes
Number of Patients With Clinical Success at Visit 2
Time frame: Visit 2: Day 4
Number of Patients With Clinical Success at Visit 3
Time frame: Visit 3: Day 11
Number of Patients With Clinical Success at EOT
Time frame: EOT: Visit at day 25
Number of Patients With Bacteriological Success at Visit 2
Time frame: Visit 2: Day 4
Number of Patients With Bacteriological Success at Visit 3
Time frame: Visit 3: Day 11
Number of Patients With Bacteriological Success at EOT
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
LEO Pharma
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fucidin® cream in people with Impetigo, run by LEO Pharma at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.