Secondarily Infected Traumatic Lesions (SITL)Phase 2NCT00758862

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

A Phase 2 study testing 2% TD1414 Cream in people with Secondarily Infected Traumatic Lesions (SITL) and Impetigo, run by LEO Pharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Secondarily Infected Traumatic Lesions (SITL), Impetigo
What is being tested?: 2% TD1414 Cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Dec 2008to Feb 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 15Show fewer

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.

Who cannot join

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

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

J&S Studies, Inc.
College Station, Texas, 77840

Other trials in United States

About this study

Conditions: Secondarily Infected Traumatic Lesions (SITL), Impetigo
Being tested: 2% TD1414 Cream
Medical subject headings: Impetigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2% TD1414 CreamDrug
Application 3 times daily for 7 days

Study groups in NCT00758862
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: 2% TD1414 Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 0 hours to 240 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Feb 2009

First posted25 Sep 2008 (estimated)
Study startDec 2008
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Secondarily Infected Traumatic Lesions (SITL)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758862
Sponsor's protocol ID: TD1414-C22
Status last verified: Jun 2018
First submitted: 23 Sep 2008
Last updated: 13 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
ClinicalTrials.gov ID: NCT00758862
Acronym / sponsor ID: TD1414-C22
Conditions: Secondarily Infected Traumatic Lesions (SITL), Impetigo
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 23 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: 2% TD1414 Cream

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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:

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
2% TD1414 CreamApplication 3 times daily for 7 days	Drug	1

Primary outcome

TD1414 Serum Concentration by Timepoint
Time frame: From 0 hours to 240 hours
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 )
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
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 )
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.
Area Under the Curve (AUC(0-t))
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
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
Time frame: From 0 hours to 240 hours
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.

Results and safety

Results posted to the registry on 23 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TD1414	20	19

Primary outcome: TD1414 Serum Concentration by Timepoint

Time frame: From 0 hours to 240 hours. Mean (Standard Deviation). Unit: pg/mL

Measure	TD1414 n = 20
12 hours Post First Application	624.3 (1255.3)
18 hours Post First Application	864.1 (1635.7)
24 hours Post First Application	1195.7 (2448.1)
36 hours Post First Application	888.4 (1878.6)
Day 3	659.1 (1461.8)
Day 4	309.0 (578.5)
Day 5	344.4 (673.0)
Day 6	178.8 (199.1)

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

Primary outcome: Peak TD1414 Serum Concentration (Cmax )

Time frame: From 0 hours to 240 hours. Geometric mean (Standard Deviation). Unit: pg/mL

Measure	TD1414 n = 20
Value	650.4 (2433.6)

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

Primary outcome: Peak Serum Concentration by Baseline Lesion Size

Time frame: From 0 hours to 240 hours. Geometric mean (Standard Deviation). Unit: pg/mL

Measure	TD1414 n = 20
<=15 cm^2	484.1 (1755.1)
>15 cm^2	1233.3 (3545.0)

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

Primary outcome: Peak Serum Concentration by SIRS Score

Time frame: From 0 hours to 240 hours. Geometric mean (Standard Deviation). Unit: pg/mL

Measure	TD1414 n = 20
SIRS score <=13	416.2 (1937.5)
SIRS score >13	1068.3 (2931.6)

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

Adverse events

Time frame: From Day 1 to Day 10. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TD1414	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Terry Jones, MD principal investigator

J&S Studies Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2% TD1414 Cream in people with Secondarily Infected Traumatic Lesions (SITL) and Impetigo, run by LEO Pharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TD1414 Serum Concentration by Timepoint (time frame: From 0 hours to 240 hours). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00758862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.