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

NCT ID: NCT00758862

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-02-28

Brief Summary

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.

Conditions

Secondarily Infected Traumatic Lesions (SITL); Impetigo

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

2% TD1414 Cream

Intervention Type: DRUG

Application 3 times daily for 7 days

Interventions

2% TD1414 Cream

Application 3 times daily for 7 days

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry Jones, MD

Role: PRINCIPAL_INVESTIGATOR

J&S Studies Inc.

Locations

J&S Studies, Inc.

College Station, Texas, United States

Countries

United States

Other Identifiers

TD1414-C22

Identifier Type: -

Identifier Source: org_study_id