Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Primary Purpose
Impetigo, Secondarily Infected Traumatic Lesions
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TD1414 2% cream
TD1414 2% cream
Bactroban® (mupirocin) 2% cream
Sponsored by
About this trial
This is an interventional treatment trial for Impetigo
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
Sites / Locations
- Anniston Medical Clinic
- Division of Dermatology, Groote Schuur Hospital, G23
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
Participants With Clinical Cure According to Investigator's Assessment
At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00626795
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impetigo, Secondarily Infected Traumatic Lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
773 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TD1414 2% cream
Intervention Description
BID 7 days
Intervention Type
Drug
Intervention Name(s)
TD1414 2% cream
Intervention Description
TID 7 days
Intervention Type
Drug
Intervention Name(s)
Bactroban® (mupirocin) 2% cream
Intervention Description
BID 7 days
Primary Outcome Measure Information:
Title
Participants With Clinical Cure According to Investigator's Assessment
Description
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).
Time Frame
At end of treatment (Day 8)
Secondary Outcome Measure Information:
Title
Participants With Clinical Cure According to Investigator's Assessment
Description
At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
Time Frame
At follow up (Day 15)
Title
Participants With Clinical Cure According to Investigator's Assessment.
Description
At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
Time Frame
At end of treatment (Day 8) and follow-up (Day 15)
Title
Participants With Bacteriological Cure According to Bacteriological Samples
Description
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.
Time Frame
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Title
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
Description
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.
Time Frame
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Title
Participants With Clinical Cure According to Investigator's Assessment
Description
At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.
Time Frame
At Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Almena L Free, MD
Organizational Affiliation
Anniston Medical Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anniston Medical Clinic
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Division of Dermatology, Groote Schuur Hospital, G23
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
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