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
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

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 August 20, 2014