- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626795
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Western Cape
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Cape Town, Western Cape, South Africa, 7925
- Division of Dermatology, Groote Schuur Hospital, G23
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Alabama
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Anniston, Alabama, United States, 36207
- Anniston Medical Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
|
BID 7 days
TID 7 days
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EXPERIMENTAL: 2
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BID 7 days
TID 7 days
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ACTIVE_COMPARATOR: 3
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BID 7 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants With Clinical Cure According to Investigator's Assessment
Time Frame: At end of treatment (Day 8)
|
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).
Each sign/symptoms of infection was assessed by use of the following 4-point scale:
The scores were summed up to a total SIRS score. Clinical cure was either of the following:
Clinical failure was either of the following:
|
At end of treatment (Day 8)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants With Clinical Cure According to Investigator's Assessment
Time Frame: At follow up (Day 15)
|
At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
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At follow up (Day 15)
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Participants With Clinical Cure According to Investigator's Assessment.
Time Frame: At end of treatment (Day 8) and follow-up (Day 15)
|
At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
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At end of treatment (Day 8) and follow-up (Day 15)
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Participants With Bacteriological Cure According to Bacteriological Samples
Time Frame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
|
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:
Bacteriological failure was any of the following:
|
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
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Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
Time Frame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
|
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
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Participants With Clinical Cure According to Investigator's Assessment
Time Frame: At Day 4
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At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.
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At Day 4
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Almena L Free, MD, Anniston Medical Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Skin Diseases, Infectious
- Staphylococcal Infections
- Skin Diseases, Bacterial
- Staphylococcal Skin Infections
- Impetigo
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Mupirocin
Other Study ID Numbers
- TD1414-C21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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