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

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Impetigo; Secondarily Infected Traumatic Lesions (SITL)

Treatments: Drug: 2% TD1414 Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758862

TD1414-C22

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Treatment:

Drug: 2% TD1414 Cream