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

NCT00758862 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	LEO Pharma
Phase	Phase 2
Status	COMPLETED
Enrolment	20
Start date	2008-12
Completion	2009-02

Conditions

• Secondarily Infected Traumatic Lesions (SITL)
• Impetigo

Interventions

• 2% TD1414 Cream

Primary outcomes

• TD1414 Serum Concentration by Timepoint — 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 ) — 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 — 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 — 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 — 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 ) — From 0 hours to 240 hours
  Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.

Countries

United States