Trial Outcomes & Findings for The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo (NCT NCT00758862)

NCT ID: NCT00758862

Last Updated: 2025-03-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From 0 hours to 240 hours

Results posted on

2025-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Age, Continuous	32.1 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: One participant withdrew at day 3 due to the participant being out of range of the inclusion criterion.

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

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
TD1414 Serum Concentration by Timepoint Day 9	99.2 pg/mL Standard Deviation 125.4
TD1414 Serum Concentration by Timepoint 12 hours Post First Application	624.3 pg/mL Standard Deviation 1255.3
TD1414 Serum Concentration by Timepoint 18 hours Post First Application	864.1 pg/mL Standard Deviation 1635.7
TD1414 Serum Concentration by Timepoint 24 hours Post First Application	1195.7 pg/mL Standard Deviation 2448.1
TD1414 Serum Concentration by Timepoint 36 hours Post First Application	888.4 pg/mL Standard Deviation 1878.6
TD1414 Serum Concentration by Timepoint Day 3	659.1 pg/mL Standard Deviation 1461.8
TD1414 Serum Concentration by Timepoint Day 4	309.0 pg/mL Standard Deviation 578.5
TD1414 Serum Concentration by Timepoint Day 5	344.4 pg/mL Standard Deviation 673.0
TD1414 Serum Concentration by Timepoint Day 6	178.8 pg/mL Standard Deviation 199.1
TD1414 Serum Concentration by Timepoint Prior last application	177.4 pg/mL Standard Deviation 220.5
TD1414 Serum Concentration by Timepoint 6 hours Post Last Application	189.9 pg/mL Standard Deviation 231.1
TD1414 Serum Concentration by Timepoint 12 hours Post Last Application	190.6 pg/mL Standard Deviation 214.0
TD1414 Serum Concentration by Timepoint 24 hours Post Last Application	108.6 pg/mL Standard Deviation 135.0
TD1414 Serum Concentration by Timepoint Day 10	47.2 pg/mL Standard Deviation 60.1

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

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.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Peak TD1414 Serum Concentration (Cmax )	650.4 pg/mL Standard Deviation 2433.6

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

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.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Peak Serum Concentration by Baseline Lesion Size <=15 cm^2	484.1 pg/mL Standard Deviation 1755.1
Peak Serum Concentration by Baseline Lesion Size >15 cm^2	1233.3 pg/mL Standard Deviation 3545.0

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

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.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Peak Serum Concentration by SIRS Score SIRS score <=13	416.2 pg/mL Standard Deviation 1937.5
Peak Serum Concentration by SIRS Score SIRS score >13	1068.3 pg/mL Standard Deviation 2931.6

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

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.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Peak Serum Concentration by Amount of TD1414 Cream Used <=2 g	323.5 pg/mL Standard Deviation 858.2
Peak Serum Concentration by Amount of TD1414 Cream Used >2 g	1081.0 pg/mL Standard Deviation 2976.6

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Time to Reach Peak Serum Concentration (Tmax )	32.08 hours Standard Deviation 59.82

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size <=15 cm^2	47.42 hours Standard Deviation 56.91
Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size >15 cm^2	23.73 hours Standard Deviation 69.77

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score <=13 cm^2	42.21 hours Standard Deviation 62.79
Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score >13 cm^2	24.22 hours Standard Deviation 58.03

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used <=2 g	28.15 hours Standard Deviation 63.90
Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used >2 g	33.65 hours Standard Deviation 62.68

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

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.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Area Under the Curve (AUC(0-t))	32138 h*pg/mL Standard Deviation 123032

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

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.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Area Under the Curve by Baseline Lesion Size <=15 cm^2	21240 h*pg/mL Standard Deviation 61954
Area Under the Curve by Baseline Lesion Size >15 cm^2	78836 h*pg/mL Standard Deviation 192236

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

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.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Area Under the Curve by SIRS Score SIRS score <=13	17923 h*pg/mL Standard Deviation 69972
Area Under the Curve by SIRS Score SIRS score >13	61488 h*pg/mL Standard Deviation 160681

PRIMARY outcome

Timeframe: From 0 hours to 240 hours

Population: AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).

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.

Outcome measures

Outcome measures
Measure	TD1414 n=20 Participants 2% TD1414 Cream: Application 3 times daily for 7 days
Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used >2 g	59932 h*pg/mL Standard Deviation 150278
Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used <=2 g	13642 h*pg/mL Standard Deviation 23828

Adverse Events

TD1414

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER