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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00758862
First received: September 23, 2008
Last updated: December 19, 2013
Last verified: August 2009
  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.


Condition Intervention Phase
Secondarily Infected Traumatic Lesions (SITL)
Impetigo
Drug: 2% TD1414 Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

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 ]

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 2% TD1414 Cream
Application 3 times daily for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758862

Locations
United States, Texas
J&S Studies, Inc.
College Station, Texas, United States, 77840
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Terry Jones, MD J&S Studies Inc.
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00758862     History of Changes
Other Study ID Numbers: TD1414-C22
Study First Received: September 23, 2008
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014