Clinical trial NCT00626795: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impetigo
Secondarily Infected Traumatic Lesions
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 773
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Participants With Clinical Cure According to Investigator's Assessment
timeFrame: At end of treatment (Day 8)
Secondary outcomes:
measure: Participants With Clinical Cure According to Investigator's Assessment
timeFrame: At follow up (Day 15)
measure: Participants With Clinical Cure According to Investigator's Assessment.
timeFrame: At end of treatment (Day 8) and follow-up (Day 15)
measure: Participants With Bacteriological Cure According to Bacteriological Samples
timeFrame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
measure: Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
timeFrame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
measure: Participants With Clinical Cure According to Investigator's Assessment
timeFrame: At Day 4
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Anniston Medical Clinic
state: Alabama
city: Cape Town
country: South Africa
facility: Division of Dermatology, Groote Schuur Hospital, G23
state: Western Cape
Study officials:
affiliation: Anniston Medical Clinic
name: Almena L Free, MD
role: PRINCIPAL_INVESTIGATOR
References: