The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
Condition: Secondarily Infected Traumatic Lesions (SITL); Impetigo
MeSH terms: Impetigo
Intervention: 2% TD1414 Cream
Intervention description: Application 3 times daily for 7 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.