Status:
COMPLETED
The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
Lead Sponsor:
LEO Pharma
Conditions:
Secondarily Infected Traumatic Lesions (SITL)
Impetigo
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 Secondar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00758862
Start Date
December 1 2008
End Date
February 1 2009
Last Update
March 13 2025
Active Locations (1)
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1
J&S Studies, Inc.
College Station, Texas, United States, 77840