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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 April 16, 2015
Gram-Positive Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Staphylococcal Skin Infections