Phase 2 N=65 Randomized Single-blind Treatment

Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Impetigo · Secondarily Infected Traumatic Lesions

Bottom Line

View on ClinicalTrials.gov: NCT00626795 ↗

Enrolled (actual)

Serious AEs

0.6%

Results posted

Jul 2018

Primary outcome: Primary: Participants With Clinical Cure According to Investigator's Assessment — 167; 184; 174; 36 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: TD1414 2% cream (Drug); Bactroban® (mupirocin) 2% cream (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: LEO Pharma
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With Clinical Cure According to Investigator's Assessment	108; 130; 120; 95; 75; 84	—
SECONDARY Participants With Clinical Cure According to Investigator's Assessment	108; 130; 120; 95; 75; 84	—
SECONDARY Participants With Clinical Cure According to Investigator's Assessment.	158; 177; 166; 45; 28; 38	—
SECONDARY Participants With Bacteriological Cure According to Bacteriological Samples	66; 80; 94; 44; 41; 24	—
SECONDARY Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples	59; 76; 88; 51; 45; 30	—
SECONDARY Participants With Clinical Cure According to Investigator's Assessment	108; 130; 120; 95; 75; 84	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00626795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.