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The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo

Primary Purpose

Secondarily Infected Traumatic Lesions (SITL), Impetigo

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
2% TD1414 Cream
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondarily Infected Traumatic Lesions (SITL)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability and willingness to comply with all the study requirements/procedures
  • Age ≥ 18 and ≤65 years
  • Primary bullous/non-bullous impetigo or SITL

  • Patients suffering from primary bullous/non-bullous impetigo must have:

    • Not more than 10 discrete lesions, and
    • A total lesional area ≥ 1 cm2 and ≤ 100 cm2, and
    • Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and
    • Total SIRS score equal to or ≥ 8

  • Patients suffering from SITL must have:

    • A total infected area of the traumatic lesion ≥ 1 cm2 and ≤ 100 cm2, and
    • Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and
    • Total SIRS score ≥ 8, and
    • SITL not caused by burns or animal/human bite
  • Amenable for treatment with topical antibiotic alone
  • Body Mass Index ≥18 and ≤ 35 kg/m2.

Exclusion Criteria:

  • Immunosuppressed state or other serious systemic disease
  • Signs and/or symptoms of systemic infection, such as malaise and fever or local adenopathy and fever
  • Unwillingness to abstain from use of any other topical products including emollients on the lesional area during the study
  • Systemic treatment with antibacterials or immunosuppressive agents (e.g. corticosteroids) within 2 days before day 1 (inhaled/intranasal steroids may be used)
  • Topical treatment with antibacterials, immunosuppressive agents (e.g. corticosteroids) or antiseptics (e.g. alcohol, chlorhexidine, hydrogen peroxide, iodine) on the lesional area within 2 days before day 1
  • Indication for surgical or systemic treatment of the SITL/impetigo
  • Known or suspected hypersensitivity to any of the components of the study medication
  • Participation in any other interventional clinical trial or use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to day 1
  • Previously enrolled in this study
  • A blood alcohol content ≥ 0.08% as determined by a Breathalyzer test
  • Known or suspected history of alcohol abuse/alcoholism or drug abuse
  • Known or suspected impairment of liver function
  • Heart rhythm disturbances or clinically significant quantitative or qualitative abnormality in the pretreatment ECG
  • Blood donation in excess of 500mL within 56 days before day 1 or donation during the study or within 3 days of leaving the study.

Sites / Locations

  • J&S Studies, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

TD1414 Serum Concentration by Timepoint
On Days 1 and 2(and possibly Day 3 depending on the time of first application on Day 1) a sample was taken for pharmacokinetic(PK) analysis at any time before first application on Day 1, and at 12±1, 18±1, 24±1 and 36±4 hours after first application. If the 36±4 hours sampling time fell on Day 3, then a second sample was also required on Day 3, but was to be obtained at 6pm or afterwards. On Days 3 to 6(and also Day 7 if the very last application fell on Day 8), one sample was taken on each day at any time during the day. On Days 7 and 8(or Days 8 and 9 if very last application was on Day 8), a sample was taken immediately before the very last application and at 6±1, 12±1 and 24±2 hours after the very last application. On Days 9 and 10, one sample was taken on each day at any time during the day. If the participant had already had a sample(s) taken on Day 9 because the timing of some of the post-last application samples fell on this day, then further samples were not required on Day 9
Peak TD1414 Serum Concentration (Cmax )
The Cmax was summarised by lesion size at baseline, by SIRS scores at baseline and by amount of TD1414 cream used. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses. For description of lesion size, SIRS score and amount of TD1414 cream used please see outcome measure 3, 4 and 5 respectively.
Peak Serum Concentration by Baseline Lesion Size
On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm². The Cmax is presented by baseline lesion size category (≤15 cm² and >15 cm²). Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Peak Serum Concentration by SIRS Score
On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s). The severity was to be recorded using the Severity of Infection Rating Scale (SIRS). For the SIRS, the following seven clinical signs/symptoms of infection were assessed: Exudates/pus Crusting Erythema Oedema Tissue warmth Itching Pain Each of the seven signs/symptoms was scored using the following scale: 0 = absent 2 = mild 4 = moderate 6 = severe The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Peak Serum Concentration by Amount of TD1414 Cream Used
The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time to Reach Peak Serum Concentration (Tmax )
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Area Under the Curve (AUC(0-t))
Area under the concentration-time curve (AUC(0-t)) from time 0 to time of last non-zero observation after dosing, calculated by linear/log trapezoidal method. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Area Under the Curve by Baseline Lesion Size
On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm². Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Area Under the Curve by SIRS Score
On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s). The severity was to be recorded using the Severity of Infection Rating Scale (SIRS). For the SIRS, the following seven clinical signs/symptoms of infection were assessed: Exudates/pus, Crusting, Erythema, Oedema, Tissue warmth, Itching and Pain. Each of the seven signs/symptoms was scored using the following scale: 0 = absent 2 = mild 4 = moderate 6 = severe The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used
The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2008
Last Updated
June 26, 2018
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00758862
Brief Title
The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
Official Title
The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A national, prospective single arm phase II study investigating the pharmacokinetics and safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondarily Infected Traumatic Lesions (SITL), Impetigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
2% TD1414 Cream
Intervention Description
Application 3 times daily for 7 days
Primary Outcome Measure Information:
Title
TD1414 Serum Concentration by Timepoint
Description
On Days 1 and 2(and possibly Day 3 depending on the time of first application on Day 1) a sample was taken for pharmacokinetic(PK) analysis at any time before first application on Day 1, and at 12±1, 18±1, 24±1 and 36±4 hours after first application. If the 36±4 hours sampling time fell on Day 3, then a second sample was also required on Day 3, but was to be obtained at 6pm or afterwards. On Days 3 to 6(and also Day 7 if the very last application fell on Day 8), one sample was taken on each day at any time during the day. On Days 7 and 8(or Days 8 and 9 if very last application was on Day 8), a sample was taken immediately before the very last application and at 6±1, 12±1 and 24±2 hours after the very last application. On Days 9 and 10, one sample was taken on each day at any time during the day. If the participant had already had a sample(s) taken on Day 9 because the timing of some of the post-last application samples fell on this day, then further samples were not required on Day 9
Time Frame
From 0 hours to 240 hours
Title
Peak TD1414 Serum Concentration (Cmax )
Description
The Cmax was summarised by lesion size at baseline, by SIRS scores at baseline and by amount of TD1414 cream used. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses. For description of lesion size, SIRS score and amount of TD1414 cream used please see outcome measure 3, 4 and 5 respectively.
Time Frame
From 0 hours to 240 hours
Title
Peak Serum Concentration by Baseline Lesion Size
Description
On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm². The Cmax is presented by baseline lesion size category (≤15 cm² and >15 cm²). Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Peak Serum Concentration by SIRS Score
Description
On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s). The severity was to be recorded using the Severity of Infection Rating Scale (SIRS). For the SIRS, the following seven clinical signs/symptoms of infection were assessed: Exudates/pus Crusting Erythema Oedema Tissue warmth Itching Pain Each of the seven signs/symptoms was scored using the following scale: 0 = absent 2 = mild 4 = moderate 6 = severe The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Peak Serum Concentration by Amount of TD1414 Cream Used
Description
The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Time to Reach Peak Serum Concentration (Tmax )
Description
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size
Description
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score
Description
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used
Description
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Area Under the Curve (AUC(0-t))
Description
Area under the concentration-time curve (AUC(0-t)) from time 0 to time of last non-zero observation after dosing, calculated by linear/log trapezoidal method. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Area Under the Curve by Baseline Lesion Size
Description
On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm². Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Area Under the Curve by SIRS Score
Description
On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s). The severity was to be recorded using the Severity of Infection Rating Scale (SIRS). For the SIRS, the following seven clinical signs/symptoms of infection were assessed: Exudates/pus, Crusting, Erythema, Oedema, Tissue warmth, Itching and Pain. Each of the seven signs/symptoms was scored using the following scale: 0 = absent 2 = mild 4 = moderate 6 = severe The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours
Title
Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used
Description
The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube. Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Time Frame
From 0 hours to 240 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability and willingness to comply with all the study requirements/procedures Age ≥ 18 and ≤65 years Primary bullous/non-bullous impetigo or SITL Patients suffering from primary bullous/non-bullous impetigo must have: Not more than 10 discrete lesions, and A total lesional area ≥ 1 cm2 and ≤ 100 cm2, and Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and Total SIRS score equal to or ≥ 8 Patients suffering from SITL must have: A total infected area of the traumatic lesion ≥ 1 cm2 and ≤ 100 cm2, and Any surrounding erythema must not extend beyond 2 cm from the edge of the lesion, and Total SIRS score ≥ 8, and SITL not caused by burns or animal/human bite Amenable for treatment with topical antibiotic alone Body Mass Index ≥18 and ≤ 35 kg/m2. Exclusion Criteria: Immunosuppressed state or other serious systemic disease Signs and/or symptoms of systemic infection, such as malaise and fever or local adenopathy and fever Unwillingness to abstain from use of any other topical products including emollients on the lesional area during the study Systemic treatment with antibacterials or immunosuppressive agents (e.g. corticosteroids) within 2 days before day 1 (inhaled/intranasal steroids may be used) Topical treatment with antibacterials, immunosuppressive agents (e.g. corticosteroids) or antiseptics (e.g. alcohol, chlorhexidine, hydrogen peroxide, iodine) on the lesional area within 2 days before day 1 Indication for surgical or systemic treatment of the SITL/impetigo Known or suspected hypersensitivity to any of the components of the study medication Participation in any other interventional clinical trial or use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to day 1 Previously enrolled in this study A blood alcohol content ≥ 0.08% as determined by a Breathalyzer test Known or suspected history of alcohol abuse/alcoholism or drug abuse Known or suspected impairment of liver function Heart rhythm disturbances or clinically significant quantitative or qualitative abnormality in the pretreatment ECG Blood donation in excess of 500mL within 56 days before day 1 or donation during the study or within 3 days of leaving the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Jones, MD
Organizational Affiliation
J&S Studies Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77840
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo

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