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

NCT ID: NCT00626795

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 773 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-06-30

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.

Conditions

Impetigo; Secondarily Infected Traumatic Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: EXPERIMENTAL

TD1414 2% cream

Intervention Type: DRUG

BID 7 days

2

Group Type: EXPERIMENTAL

TD1414 2% cream

Intervention Type: DRUG

TID 7 days

3

Group Type: ACTIVE_COMPARATOR

Bactroban® (mupirocin) 2% cream

Intervention Type: DRUG

BID 7 days

Interventions

TD1414 2% cream

BID 7 days

Intervention Type: DRUG

TD1414 2% cream

TID 7 days

Intervention Type: DRUG

Bactroban® (mupirocin) 2% cream

BID 7 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Almena L Free, MD

Role: PRINCIPAL_INVESTIGATOR

Anniston Medical Clinic

Locations

Anniston Medical Clinic

Anniston, Alabama, United States

Division of Dermatology, Groote Schuur Hospital, G23

Cape Town, Western Cape, South Africa

Countries

United States; South Africa

Other Identifiers

TD1414-C21

Identifier Type: -

Identifier Source: org_study_id