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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% TD1414 Cream | Drug | Application 3 times daily for 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| 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. |
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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:
Patients suffering from SITL must have:
Amenable for treatment with topical antibiotic alone
Body Mass Index ≥18 and ≤ 35 kg/m2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Jones, MD | J&S Studies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| J&S Studies, Inc. | College Station | Texas | 77840 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TD1414 | 2% TD1414 Cream: Application 3 times on lesions area(s) daily for 7 days. A maximum of 0.5g of cream on a 100 cm2 lesion area was to be used per application. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TD1414 | 2% TD1414 Cream: Application 3 times daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | One participant withdrew at day 3 due to the participant being out of range of the inclusion criterion. | Posted | Mean | Standard Deviation | pg/mL | From 0 hours to 240 hours |
From Day 1 to Day 10
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TD1414 | 2% TD1414 Cream: Application 3 times daily for 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | disclosure@leo-pharma.com |
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| ID | Term |
|---|---|
| D007169 | Impetigo |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| Time to Reach Peak Serum Concentration (Tmax ) | Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses. | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| 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. | From 0 hours to 240 hours |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | TD1414 | 2% TD1414 Cream: Application 3 times daily for 7 days |
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| Primary | 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. | Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Geometric Mean | Standard Deviation | pg/mL | From 0 hours to 240 hours |
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| Primary | 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. | Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Geometric Mean | Standard Deviation | pg/mL | From 0 hours to 240 hours |
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| Primary | 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. | Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Geometric Mean | Standard Deviation | pg/mL | From 0 hours to 240 hours |
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| Primary | 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. | Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Geometric Mean | Standard Deviation | pg/mL | From 0 hours to 240 hours |
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| Primary | Time to Reach Peak Serum Concentration (Tmax ) | Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses. | Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Median | Standard Deviation | hours | From 0 hours to 240 hours |
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| Primary | 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. | Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Median | Standard Deviation | hours | From 0 hours to 240 hours |
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| Primary | 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. | AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Median | Standard Deviation | hours | From 0 hours to 240 hours |
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| Primary | 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. | Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Median | Standard Deviation | hours | From 0 hours to 240 hours |
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| Primary | 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. | AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Geometric Mean | Standard Deviation | h*pg/mL | From 0 hours to 240 hours |
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| Primary | 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. | AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Geometric Mean | Standard Deviation | h*pg/mL | From 0 hours to 240 hours |
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| Primary | 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. | AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Geometric Mean | Standard Deviation | h*pg/mL | From 0 hours to 240 hours |
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| Primary | 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. | AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL). | Posted | Geometric Mean | Standard Deviation | h*pg/mL | From 0 hours to 240 hours |
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The Company acknowledges the investigator's right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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