Trial Outcomes & Findings for Fucidin® Cream in the Treatment of Impetigo (NCT NCT00986856)
NCT ID: NCT00986856
Last Updated: 2025-03-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
EOT: Visit at Day 25
Results posted on
2025-03-06
Participant Flow
Participant milestones
| Measure |
Fucidin® Cream
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
16
|
|
Overall Study
COMPLETED
|
42
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fucidin® Cream in the Treatment of Impetigo
Baseline characteristics by cohort
| Measure |
Fucidin® Cream
n=42 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=16 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
42 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.8 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
6.3 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
5.2 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
32 participants
n=5 Participants
|
15 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
10 participants
n=5 Participants
|
1 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
S.aureus susceptible to fusidic acid
S. aureus susceptible to fusidic acid
|
12 S. aureus
n=5 Participants
|
4 S. aureus
n=7 Participants
|
16 S. aureus
n=5 Participants
|
|
S.aureus susceptible to fusidic acid
S. aureus resistant to fusidic acid
|
18 S. aureus
n=5 Participants
|
8 S. aureus
n=7 Participants
|
26 S. aureus
n=5 Participants
|
|
S.aureus susceptible to fusidic acid
No S. aureus isolated
|
12 S. aureus
n=5 Participants
|
4 S. aureus
n=7 Participants
|
16 S. aureus
n=5 Participants
|
PRIMARY outcome
Timeframe: EOT: Visit at Day 25Population: The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline
Outcome measures
| Measure |
Fucidin® Cream
n=33 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=13 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
Clinical and bacteriological success
|
16 Participants
|
1 Participants
|
|
Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
Clinical and bacteriological failure
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Visit 2: Day 4Population: The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)
Outcome measures
| Measure |
Fucidin® Cream
n=40 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=16 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Number of Patients With Clinical Success at Visit 2
Success
|
18 Participants
|
2 Participants
|
|
Number of Patients With Clinical Success at Visit 2
Failure
|
22 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Visit 3: Day 11Population: The analysis population were those patients who had a visit 3 observation
Outcome measures
| Measure |
Fucidin® Cream
n=34 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=10 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Number of Patients With Clinical Success at Visit 3
Success
|
27 Participants
|
7 Participants
|
|
Number of Patients With Clinical Success at Visit 3
Failure
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: EOT: Visit at day 25Population: The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)
Outcome measures
| Measure |
Fucidin® Cream
n=40 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=16 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Number of Patients With Clinical Success at EOT
Success
|
27 Participants
|
7 Participants
|
|
Number of Patients With Clinical Success at EOT
Failure
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Visit 2: Day 4Population: The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline
Outcome measures
| Measure |
Fucidin® Cream
n=33 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=13 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Number of Patients With Bacteriological Success at Visit 2
Success
|
6 Participants
|
0 Participants
|
|
Number of Patients With Bacteriological Success at Visit 2
Failure
|
27 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Visit 3: Day 11Population: The analysis population were those patients who had a visit 3 observation
Outcome measures
| Measure |
Fucidin® Cream
n=27 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=6 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Number of Patients With Bacteriological Success at Visit 3
Success
|
17 Participants
|
1 Participants
|
|
Number of Patients With Bacteriological Success at Visit 3
Failure
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: EOT: Visit at day 25Population: The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline
Outcome measures
| Measure |
Fucidin® Cream
n=33 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=13 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Number of Patients With Bacteriological Success at EOT
Success
|
17 Participants
|
1 Participants
|
|
Number of Patients With Bacteriological Success at EOT
Failure
|
16 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: EOT: Visit at day 25Population: The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)
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.
Outcome measures
| Measure |
Fucidin® Cream
n=40 Participants
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=16 Participants
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).
|
-3.9 Units on a scale
Standard Error 3.5
|
-1.2 Units on a scale
Standard Error 4.4
|
Adverse Events
Fucidin® Cream
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fucidin® Cream Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fucidin® Cream
n=40 participants at risk
Fucidin® cream 20 mg/g 3 times daily for 10 days
|
Fucidin® Cream Vehicle
n=16 participants at risk
Fucidin® cream vehicle 3 times daily for 10 days
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.5%
1/40 • Number of events 1
All 58 randomised patients comprised the safety analysis set except patients who: 1. did not provide any post randomisation safety data or 2. did not use any trial medication confirmed by return of all trial medication given to the patients.
|
0.00%
0/16
All 58 randomised patients comprised the safety analysis set except patients who: 1. did not provide any post randomisation safety data or 2. did not use any trial medication confirmed by return of all trial medication given to the patients.
|
|
Infections and infestations
Infections and infestations
|
7.5%
3/40 • Number of events 3
All 58 randomised patients comprised the safety analysis set except patients who: 1. did not provide any post randomisation safety data or 2. did not use any trial medication confirmed by return of all trial medication given to the patients.
|
25.0%
4/16 • Number of events 4
All 58 randomised patients comprised the safety analysis set except patients who: 1. did not provide any post randomisation safety data or 2. did not use any trial medication confirmed by return of all trial medication given to the patients.
|
|
Skin and subcutaneous tissue disorders
Infections and
|
2.5%
1/40 • Number of events 1
All 58 randomised patients comprised the safety analysis set except patients who: 1. did not provide any post randomisation safety data or 2. did not use any trial medication confirmed by return of all trial medication given to the patients.
|
0.00%
0/16
All 58 randomised patients comprised the safety analysis set except patients who: 1. did not provide any post randomisation safety data or 2. did not use any trial medication confirmed by return of all trial medication given to the patients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place