The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
This study has been completed.
Information provided by (Responsible Party):
First received: September 23, 2008
Last updated: December 19, 2013
Last verified: August 2009
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.
Secondarily Infected Traumatic Lesions (SITL)
Drug: 2% TD1414 Cream
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
Primary Outcome Measures:
- To determine the pharmacokinetic profile of TD1414 after repeated topical administration of 2% TD1414 cream for the treatment of SITL or impetigo in adult patients [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the safety of 2% TD1414 cream in the treatment of SITL or impetigo in adult patients [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2009 (Final data collection date for primary outcome measure)
Drug: 2% TD1414 Cream
Application 3 times daily for 7 days
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00758862
|J&S Studies, Inc.
|College Station, Texas, United States, 77840 |
||Terry Jones, MD
||J&S Studies Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 23, 2008
||December 19, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Gram-Positive Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Staphylococcal Skin Infections