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College Station, Texas 77840


Purpose:

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.


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.


NCT ID:

NCT00758862


Primary Contact:

Principal Investigator
Terry Jones, MD
J&S Studies Inc.


Backup Contact:

N/A


Location Contact:

College Station, Texas 77840
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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