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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

TD1414 2% cream

Bactroban® (mupirocin) 2% cream

About this trial

This is an interventional treatment trial for Impetigo

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Anniston Medical Clinic
Division of Dermatology, Groote Schuur Hospital, G23

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Participants With Clinical Cure According to Investigator's Assessment

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). Exudates/pus Crusting Erythema Oedema Tissue Warmth Itching Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: 0 = absent 2 = mild 4 = moderate 6 = severe The scores were summed up to a total SIRS score. Clinical cure was either of the following: Total absence of signs and symptoms of impetigo/SITL OR Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4. Clinical failure was either of the following: Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).

Secondary Outcome Measures

Participants With Clinical Cure According to Investigator's Assessment

At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.

Participants With Clinical Cure According to Investigator's Assessment.

At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.

Participants With Bacteriological Cure According to Bacteriological Samples

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: Eradication of the baseline pathogen. Presumed eradication of the baseline pathogen Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic. Bacteriological failure was any of the following: Documented lack of eradication of the baseline pathogen. Documented relapse (re-infection) with the baseline pathogen Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.

Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples

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.

Participants With Clinical Cure According to Investigator's Assessment

At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.

Full Information

NCT ID

NCT00626795

First Posted

February 21, 2008

Last Updated

August 10, 2018

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00626795

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impetigo, Secondarily Infected Traumatic Lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

773 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Title

2

Arm Type

Experimental

Arm Title

3

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

TD1414 2% cream

Intervention Description

BID 7 days

Intervention Type

Drug

Intervention Name(s)

TD1414 2% cream

Intervention Description

TID 7 days

Intervention Type

Drug

Intervention Name(s)

Bactroban® (mupirocin) 2% cream

Intervention Description

BID 7 days

Primary Outcome Measure Information:

Title

Participants With Clinical Cure According to Investigator's Assessment

Description

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). Exudates/pus Crusting Erythema Oedema Tissue Warmth Itching Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: 0 = absent 2 = mild 4 = moderate 6 = severe The scores were summed up to a total SIRS score. Clinical cure was either of the following: Total absence of signs and symptoms of impetigo/SITL OR Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4. Clinical failure was either of the following: Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).

Time Frame

At end of treatment (Day 8)

Secondary Outcome Measure Information:

Title

Participants With Clinical Cure According to Investigator's Assessment

Description

At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.

Time Frame

At follow up (Day 15)

Title

Participants With Clinical Cure According to Investigator's Assessment.

Description

At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.

Time Frame

At end of treatment (Day 8) and follow-up (Day 15)

Title

Participants With Bacteriological Cure According to Bacteriological Samples

Description

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: Eradication of the baseline pathogen. Presumed eradication of the baseline pathogen Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic. Bacteriological failure was any of the following: Documented lack of eradication of the baseline pathogen. Documented relapse (re-infection) with the baseline pathogen Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.

Time Frame

At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up

Title

Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples

Description

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.

Time Frame

At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up

Title

Participants With Clinical Cure According to Investigator's Assessment

Description

At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.

Time Frame

At Day 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Almena L Free, MD

Organizational Affiliation

Anniston Medical Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anniston Medical Clinic

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Division of Dermatology, Groote Schuur Hospital, G23

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7925

Country

South Africa

Impetigo, Secondarily Infected Traumatic Lesions

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial