Clinical trial NCT00758862: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondarily Infected Traumatic Lesions (SITL)
Impetigo
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: TD1414 Serum Concentration by Timepoint
timeFrame: From 0 hours to 240 hours
measure: Peak TD1414 Serum Concentration (Cmax )
timeFrame: From 0 hours to 240 hours
measure: Peak Serum Concentration by Baseline Lesion Size
timeFrame: From 0 hours to 240 hours
measure: Peak Serum Concentration by SIRS Score
timeFrame: From 0 hours to 240 hours
measure: Peak Serum Concentration by Amount of TD1414 Cream Used
timeFrame: From 0 hours to 240 hours
measure: Time to Reach Peak Serum Concentration (Tmax )
timeFrame: From 0 hours to 240 hours
measure: Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size
timeFrame: From 0 hours to 240 hours
measure: Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score
timeFrame: From 0 hours to 240 hours
measure: Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used
timeFrame: From 0 hours to 240 hours
measure: Area Under the Curve (AUC(0-t))
timeFrame: From 0 hours to 240 hours
measure: Area Under the Curve by Baseline Lesion Size
timeFrame: From 0 hours to 240 hours
measure: Area Under the Curve by SIRS Score
timeFrame: From 0 hours to 240 hours
measure: Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used
timeFrame: From 0 hours to 240 hours
Secondary outcomes:
Other outcomes:
Locations:
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
Study officials:
affiliation: J&S Studies Inc.
name: Terry Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: