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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

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.