Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Information source: LEO Pharma
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Impetigo; Secondarily Infected Traumatic Lesions
Intervention: Bactroban® (mupirocin) 2% Cream (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: LEO Pharma Official(s) and/or principal investigator(s):
Almena L Free, MD, Principal Investigator, Affiliation: Anniston Medical Clinic
Overall contact:
Anne-Marie R Larsen, DVM, Phone: +4544945888, Email: anne-marie.larsen@leo-pharma.com
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.
Clinical Details
Official title: Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical cure at end of treatment according to invstigator's assessment
Secondary outcome: Clinical cure at follow-up according to investigator's assessment.
Clinical cure at end of treatment and follow-up according to investigator's assessment.
Bacteriological cure at end of treatment, follow-up, and end of treatment and follow-up according
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Anne-Marie R Larsen, DVM, Phone: +4544945888, Email: anne-marie.larsen@leo-pharma.com
Anniston Medical Clinic, Anniston, Alabama 36207, United States; Recruiting
Almena L Free, MD, Phone: 256-236-5361
Almena L Free, MD, Principal Investigator
Additional Information
Starting date: February 2008
Ending date: February 2009
Last updated: February 21, 2008
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