Efficacy, Safety, and Tolerability of TD1414 2% Cream in... | NCT00626795 | Trialant
NCT00626795
Sponsor
LEO Pharma
Status
Completed
Last Update Posted
Mar 12, 2025Actual
Enrollment
773Actual
Phase
Phase 2
Conditions
Impetigo
Secondarily Infected Traumatic Lesions
Interventions
TD1414 2% cream
TD1414 2% cream
Bactroban® (mupirocin) 2% cream
Countries
United States
South Africa
Protocol Section
Identification Module
NCT ID
NCT00626795
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TD1414-C21
Secondary IDs
Not provided
Brief Title
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Official Title
Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Acronym
Not provided
Organization
LEO PharmaINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2008
Primary Completion Date
Mar 2009Actual
Completion Date
Jun 2009Actual
First Submitted Date
Feb 21, 2008
First Submission Date that Met QC Criteria
Feb 21, 2008
First Posted Date
Feb 29, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 26, 2018
Results First Submitted that Met QC Criteria
Jun 26, 2018
Results First Posted Date
Jul 23, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 21, 2025
Last Update Posted Date
Mar 12, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
LEO PharmaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.
Detailed Description
Not provided
Conditions Module
Conditions
Impetigo
Secondarily Infected Traumatic Lesions
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
773Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Drug: TD1414 2% cream
2
Experimental
Drug: TD1414 2% cream
3
Active Comparator
Drug: Bactroban® (mupirocin) 2% cream
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TD1414 2% cream
Drug
BID 7 days
1
TD1414 2% cream
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Participants With Clinical Cure According to Investigator's Assessment
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.
Investigator's assessment of severity of infections (SIRS).
Exudates/pus
Crusting
Erythema
Oedema
Tissue Warmth
Itching
Pain
Each sign/symptoms of infection was assessed by use of the following 4-point scale:
0 = absent
2 = mild
4 = moderate
6 = severe
The scores were summed up to a total SIRS score.
Clinical cure was either of the following:
Total absence of signs and symptoms of impetigo/SITL OR
Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4.
Clinical failure was either of the following:
Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure
Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
At end of treatment (Day 8)
Secondary Outcomes
Measure
Description
Time Frame
Participants With Clinical Cure According to Investigator's Assessment
At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
At follow up (Day 15)
Participants With Clinical Cure According to Investigator's Assessment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent from patient and/or legally acceptable representative has been obtained
Outpatients of any sex or ethnic origin
Patients >= 2 years of age (depending on study step)
Patients must be suffering from primary bullous/non-bullous impetigo or SITL
Exclusion Criteria:
Presence of skin diseases at or near the investigational area
Immunosuppressed state or other serious systemic disease
Signs and/or symptoms of systemic infection
Presence of skin infection/disorder not amenable to topical antibacterial treatment only
Presence of secondarily-infected animal/human bite
Presence of secondarily infected burnwound
Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs
Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream
Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream
Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation
Patients previously enrolled/randomised in this study
Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
2 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Almena L Free, MD
Anniston Medical Clinic
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Anniston Medical Clinic
Anniston
Alabama
36207
United States
Division of Dermatology, Groote Schuur Hospital, G23
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
An open-label treatment consisting of one arm with 4 age groups of 16 participants treated with TD1414 cream three times daily was used in a stepwise inclusion, to detect major safety issues that could prevent the study from proceeding. The participants in the open-label phase were not included the efficacy analysis or in the randomized population
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TD1414 BID
TD1414 2% cream: two times daily (BID) 7 days
FG001
TD1414 TID
TD1414 2% cream: three times daily (TID) 7 days
Periods
Title
Milestones
Reasons Not Completed
Open-label TD1414 Cream TID Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Investigator
Drug
TID 7 days
2
Bactroban® (mupirocin) 2% cream
Drug
BID 7 days
3
At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
At end of treatment (Day 8) and follow-up (Day 15)
Participants With Bacteriological Cure According to Bacteriological Samples
At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.
Bacteriological cure was either of the following:
Eradication of the baseline pathogen.
Presumed eradication of the baseline pathogen
Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.
Bacteriological failure was any of the following:
Documented lack of eradication of the baseline pathogen.
Documented relapse (re-infection) with the baseline pathogen
Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic
Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.
At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based.
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Participants With Clinical Cure According to Investigator's Assessment
At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.
At Day 4
Cape Town
Western Cape
7925
South Africa
FG002
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days
FG0000 subjects
FG00165 subjects
FG0020 subjects
COMPLETED
FG0000 subjects
FG00164 subjects
FG0020 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
Blinded Treatment
Type
Comment
Milestone Data
STARTED
FG000204 subjects
FG001205 subjects
FG002205 subjects
COMPLETED
FG000194 subjects
FG001200 subjects
FG002196 subjects
NOT COMPLETED
FG00010 subjects
FG0015 subjects
FG0029 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0002 subjects
FG0010 subjects
FG0020 subjects
Unacceptable adverse event
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TD1414 BID
TD1414 2% cream: two times daily (BID) 7 days
BG001
TD1414 TID
TD1414 2% cream: three times daily (TID) 7 days
BG002
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000204
BG001205
BG002205
BG003614
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
Mean
Standard Deviation
years
Title
Denominators
Categories
Participants assigned to open-label TD1414 TID
ParticipantsBG0000
ParticipantsBG00165
ParticipantsBG0020
ParticipantsBG003
Age, Customized
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
Count of Participants
Participants
Title
Denominators
Categories
Participants assigned to open-label TD1414 TID
ParticipantsBG0000
ParticipantsBG00165
ParticipantsBG002
Sex: Female, Male
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
Count of Participants
Participants
Title
Denominators
Categories
Participants assigned to open-label TD1414 TID
ParticipantsBG0000
ParticipantsBG00165
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
ParticipantsBG000204
ParticipantsBG001205
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Participants With Clinical Cure According to Investigator's Assessment
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.
Investigator's assessment of severity of infections (SIRS).
Exudates/pus
Crusting
Erythema
Oedema
Tissue Warmth
Itching
Pain
Each sign/symptoms of infection was assessed by use of the following 4-point scale:
0 = absent
2 = mild
4 = moderate
6 = severe
The scores were summed up to a total SIRS score.
Clinical cure was either of the following:
Total absence of signs and symptoms of impetigo/SITL OR
Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4.
Clinical failure was either of the following:
Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure
Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.
Posted
Count of Participants
Participants
At end of treatment (Day 8)
ID
Title
Description
OG000
TD1414 BID
TD1414 2% cream: two times daily (BID) for 7 days
OG001
TD1414 TID
TD1414 2% cream: three times daily (TID) for 7 days
OG002
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
Units
Counts
Participants
OG000203
OG001205
OG002204
Title
Denominators
Categories
Title
Measurements
Clinical cure
OG000167
OG001184
OG002174
Clinical failure
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Difference in percentage
4.56
2-Sided
95
-1.59
10.71
Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).
Non-Inferiority
The lower confidence limit greater or equal to -12.5% indicates non-inferiority.
OG000
OG002
Secondary
Participants With Clinical Cure According to Investigator's Assessment
At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.
Posted
Count of Participants
Participants
At follow up (Day 15)
ID
Title
Description
OG000
TD1414 BID
TD1414 2% cream: two times daily (BID) for 7 days
OG001
TD1414 TID
TD1414 2% cream: three times daily (TID) for 7 days
OG002
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
Units
Counts
Participants
Secondary
Participants With Clinical Cure According to Investigator's Assessment.
At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.
Posted
Count of Participants
Participants
At end of treatment (Day 8) and follow-up (Day 15)
ID
Title
Description
OG000
TD1414 BID
TD1414 2% cream: two times daily (BID) for 7 days
OG001
TD1414 TID
TD1414 2% cream: three times daily (TID) for 7 days
OG002
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
Units
Counts
Participants
Secondary
Participants With Bacteriological Cure According to Bacteriological Samples
At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.
Bacteriological cure was either of the following:
Eradication of the baseline pathogen.
Presumed eradication of the baseline pathogen
Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.
Bacteriological failure was any of the following:
Documented lack of eradication of the baseline pathogen.
Documented relapse (re-infection) with the baseline pathogen
Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic
Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.
Only the randomized participants that were infected with S. aureus or S. pyogenes at baseline were included in the analysis.
Posted
Count of Participants
Participants
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
ID
Title
Description
OG000
TD1414 BID
TD1414 2% cream: two times daily (BID) for 7 days
OG001
TD1414 TID
TD1414 2% cream: three times daily (TID) for 7 days
Secondary
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.
At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based.
All participants randomized to blinded treatment who received at least one application of study medication and were infected with S. aureus or S. pyogenes at baseline were included in the analysis.
Posted
Count of Participants
Participants
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
ID
Title
Description
OG000
TD1414 BID
TD1414 2% cream: two times daily (BID) for 7 days
OG001
TD1414 TID
TD1414 2% cream: three times daily (TID) for 7 days
OG002
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
Secondary
Participants With Clinical Cure According to Investigator's Assessment
At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.
All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.
Posted
Count of Participants
Participants
At Day 4
ID
Title
Description
OG000
TD1414 BID
TD1414 2% cream: two times daily (BID) for 7 days
OG001
TD1414 TID
TD1414 2% cream: three times daily (TID) for 7 days
OG002
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
Units
Counts
Participants
Time Frame
From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
Description
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
TD1414 TID >=16 Years
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
0
17
6
17
EG001
TD1414 TID >=12 to <16 Years
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
0
16
5
16
EG002
TD1414 TID >=6 to <12 Years
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
0
16
2
16
EG003
TD1414 TID >=2 to <6 Years
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
0
16
3
16
EG004
TD1414 BID
Blinded treatment TD1414 2% cream: two times daily (BID) for 7 days
2
203
61
203
EG005
TD1414 TID
Blinded treatment TD1414 2% cream: three times daily (TID) for 7 days
2
205
49
205
EG006
Bactroban® TID
Blinded treatment Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
0
204
34
204
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pancytopenia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG0030 affected16 at risk
EG0040 affected203 at risk
EG0051 affected205 at risk
EG0060 affected204 at risk
Hyperthermia
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Penetrating abdominal trauma
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Shunt occlusion
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG0030 affected16 at risk
EG0040 affected203 at risk
EG0052 affected205 at risk
EG0060 affected204 at risk
Aneamia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Long QT syndrome
Cardiac disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Application site irritation
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Application site pain
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Application site pruritus
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0002 affected17 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Treatment failure
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Application site swelling
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Condition aggravated
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Local swelling
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Oedema peripheral
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Impetigo
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Skin infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Tinea capitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Human bite
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0002 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Blood pressure increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Body temperature increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Liver function test abnormal
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Transaminases increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Ligament disorder
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Joint contracture
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Headache
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Pharyngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Tonsillar inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Hypertension
Vascular disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Haematoma
Vascular disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Hot flush
Vascular disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Streptococcal
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Tinea infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Wound infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected17 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected17 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submit-ted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trial Disclosure Manager
LEO Pharma A/S
+45 4494 5888
disclosure@leo-pharma.com
ID
Term
D007169
Impetigo
Ancestor Terms
ID
Term
D013207
Staphylococcal Skin Infections
D013203
Staphylococcal Infections
D016908
Gram-Positive Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
D013290
Streptococcal Infections
D017192
Skin Diseases, Bacterial
D012874
Skin Diseases, Infectious
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D016712
Mupirocin
Ancestor Terms
ID
Term
D004852
Epoxy Compounds
D004988
Ethers, Cyclic
D004987
Ethers
D009930
Organic Chemicals
D011714
Pyrans
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D005227
Fatty Acids
D008055
Lipids
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0010 subjects
FG0021 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0021 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
Other reasons
FG0002 subjects
FG0010 subjects
FG0022 subjects
Missing reason for withdrawal
FG0005 subjects
FG0013 subjects
FG0025 subjects
65
Title
Measurements
BG00118.4± 20.0
BG00318.4± 20.0
Participants randomized to blinded treatment
ParticipantsBG000204
ParticipantsBG001205
ParticipantsBG002205
ParticipantsBG003614
Title
Measurements
BG00038.6± 14.8
BG00136.3± 14.3
BG00238.3± 15.3
BG003
0
ParticipantsBG00365
Title
Measurements
≥16 years old
BG0000
BG00117
BG0020
BG00317
≥12 to <16 years old
BG0000
BG00116
BG0020
BG00316
≥6 to <12 years old
BG0000
BG00116
BG0020
BG00316
≥2 to <6 years old
BG0000
BG00116
BG0020
BG00316
Participants randomized to blinded treatment
ParticipantsBG000204
ParticipantsBG001205
ParticipantsBG002205
ParticipantsBG003614
Title
Measurements
≥16 years old
BG000193
BG001194
BG002195
BG003
0
ParticipantsBG00365
Title
Measurements
Female
BG00135
BG00335
Male
BG00130
BG00330
Participants randomized to blinded treatment
ParticipantsBG000204
ParticipantsBG001205
ParticipantsBG002205
ParticipantsBG003614
Title
Measurements
Female
BG00097
BG00193
BG002110
BG003
205
ParticipantsBG003614
Title
Measurements
BG00085
BG00179
BG00273
BG003237
South Africa
ParticipantsBG000204
ParticipantsBG001205
ParticipantsBG002205
ParticipantsBG003614
Title
Measurements
BG000119
BG001126
BG002132
BG003
OG00036
OG00121
OG00230
Difference in percentage
-3.35
2-Sided
95
-10.28
3.57
Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).
Non-Inferiority
The lower confidence limit greater or equal to -12.5% indicates non-inferiority.
OG000203
OG001205
OG002204
Title
Denominators
Categories
Title
Measurements
Clinical cure
OG000173
OG001188
OG002185
Clinical failure
OG00030
OG00117
OG00219
OG000203
OG001205
OG002204
Title
Denominators
Categories
Clinical cure
Title
Measurements
OG000158
OG001177
OG002166
Clinical failure
Title
Measurements
OG00045
OG00128
OG00238
OG002
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days