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TerminatedNCT00986856Updated Mar 6, 2025Results posted

Fucidin® Cream in the Treatment of Impetigo

A Phase 4 interventional study of Fucidin® cream in Impetigo, sponsored by LEO Pharma. Terminated at 2 sites in 2 countries. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by LEO Pharma · Phase 4, Interventional, and Treatment

Why this study was terminated
Enrollment failed
Phase
Phase 4
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
2 Years to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Impetigo

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03

In context

Impetigo

26 studies on the registry are indexed under Impetigo; 3 are open to participants now.

This study's enrollment of 58 is below the median of 314 across 22 interventional studies indexed under Impetigo.

Browse Impetigo studies →

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Fucidin® cream

    Drug: Fucidin® cream

  • Placebo comparator
    Fucidin® cream vehicle

    Drug: Fucidin® cream

Interventions

  • DrugFucidin® cream
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Number of Patients With Clinical Success at Visit 2

    Time frame: Visit 2: Day 4

  2. Number of Patients With Clinical Success at Visit 3

    Time frame: Visit 3: Day 11

  3. Number of Patients With Clinical Success at EOT

    Time frame: EOT: Visit at day 25

  4. Number of Patients With Bacteriological Success at Visit 2

    Time frame: Visit 2: Day 4

  5. Number of Patients With Bacteriological Success at Visit 3

    Time frame: Visit 3: Day 11

  6. Number of Patients With Bacteriological Success at EOT

    Time frame: EOT: Visit at day 25

  7. 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.

    Time frame: EOT: Visit at day 25

07

Results

Posted Sep 29, 2010
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.

Participant flow

Participant flow — Overall Study
MilestoneFucidin® CreamFucidin® Cream Vehicle
Started4216
Completed4216
Not completed00

Outcome measures

PrimaryNumber 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
Reported as:
Number · Participants
Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
ParticipantsFucidin® CreamFucidin® Cream Vehicle
Clinical and bacteriological success161
Clinical and bacteriological failure1712
Statistical analysis
  • Fucidin® Cream vs Fucidin® Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.01 (Test for the hypothesis of odds ratio equal to 1.) · Odds ratio (or): 13.2 · 95% CI 1.4 to 120.4
SecondaryNumber of Patients With Clinical Success at Visit 2
Time frame:
Visit 2: Day 4
Reported as:
Number · Participants
Number of Patients With Clinical Success at Visit 2
ParticipantsFucidin® CreamFucidin® Cream Vehicle
Success182
Failure2214
Statistical analysis
  • Fucidin® Cream vs Fucidin® Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.023 · Odds ratio (or): 5.7 · 95% CI 1.1 to 28.6
SecondaryNumber of Patients With Clinical Success at Visit 3
Time frame:
Visit 3: Day 11
Reported as:
Number · Participants
Number of Patients With Clinical Success at Visit 3
ParticipantsFucidin® CreamFucidin® Cream Vehicle
Success277
Failure73
Statistical analysis
  • Fucidin® Cream vs Fucidin® Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.54 · Odds ratio (or): 1.7 · 95% CI 0.3 to 8.1
SecondaryNumber of Patients With Clinical Success at EOT
Time frame:
EOT: Visit at day 25
Reported as:
Number · Participants
Number of Patients With Clinical Success at EOT
ParticipantsFucidin® CreamFucidin® Cream Vehicle
Success277
Failure139
Statistical analysis
  • Fucidin® Cream vs Fucidin® Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.1 · Odds ratio (or): 2.7 · 95% CI 0.8 to 8.8
SecondaryNumber of Patients With Bacteriological Success at Visit 2
Time frame:
Visit 2: Day 4
Reported as:
Number · Participants
Number of Patients With Bacteriological Success at Visit 2
ParticipantsFucidin® CreamFucidin® Cream Vehicle
Success60
Failure2713
Statistical analysis
  • Fucidin® Cream vs Fucidin® Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.1
SecondaryNumber of Patients With Bacteriological Success at Visit 3
Time frame:
Visit 3: Day 11
Reported as:
Number · Participants
Number of Patients With Bacteriological Success at Visit 3
ParticipantsFucidin® CreamFucidin® Cream Vehicle
Success171
Failure105
Statistical analysis
  • Fucidin® Cream vs Fucidin® Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.043 · Mean difference (final values): 8.5 · 95% CI 0.9 to 83.5
SecondaryNumber of Patients With Bacteriological Success at EOT
Time frame:
EOT: Visit at day 25
Reported as:
Number · Participants
Number of Patients With Bacteriological Success at EOT
ParticipantsFucidin® CreamFucidin® Cream Vehicle
Success171
Failure1612
Statistical analysis
  • Fucidin® Cream vs Fucidin® Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.007 · Odds ratio (or): 12.8 · 95% CI 1.5 to 109.6
SecondaryThe 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.

Time frame:
EOT: Visit at day 25
Reported as:
Mean · Units on a scale
The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).
Units on a scaleFucidin® CreamFucidin® Cream Vehicle
The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).-3.9 ± 3.5-1.2 ± 4.4
Statistical analysis
  • Fucidin® Cream vs Fucidin® Cream Vehicle · Regression, Linear · p = 0.008 · Mean difference (final values): -2.8 · 95% CI -4.8 to -0.8

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fucidin® Cream—0/40 (0%)5/40 (12.5%)
Fucidin® Cream Vehicle—0/16 (0%)4/16 (25%)
Most frequent other events
Most frequent other events
EventFucidin® CreamFucidin® Cream Vehicle
Infections and infestationsInfections and infestations3/404/16
Gastrointestinal disordersGastrointestinal disorders1/400/16
Infections andSkin and subcutaneous tissue disorders1/400/16

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Fucidin® CreamFucidin® Cream VehicleTotal
<=18 years421658
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)Fucidin® CreamFucidin® Cream VehicleTotal
Mean4.8 ± 2.76.3 ± 2.95.2 ± 2.8
Sex: Female, Male
Sex: Female, Male(Participants)Fucidin® CreamFucidin® Cream VehicleTotal
Female18826
Male24832
Region of Enrollment
Region of Enrollment(participants)Fucidin® CreamFucidin® Cream VehicleTotal
Sweden321547
Norway10111
S.aureus susceptible to fusidic acid
S.aureus susceptible to fusidic acid(S. aureus)Fucidin® CreamFucidin® Cream VehicleTotal
S. aureus susceptible to fusidic acid12416
S. aureus resistant to fusidic acid18826
No S. aureus isolated12416
08

Study locations

2 sites
  • Institute of Internal Medicin, Haukeland University Hospital
    Bergen, 5021, Norway
  • Vårdcentrum Kungshöjd
    Göteborg, 411 19, Sweden
09

References and documents

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00986856
Lead sponsor
LEO Pharma
First posted
Sep 30, 2009
Start date
May 2004
Primary completion
Mar 2005
Completion
Mar 2005
Results posted
Sep 29, 2010
Last update
Mar 6, 2025

Study contacts

Medical Expert
study director · LEO Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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