Phase 2 N=20 Treatment

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

Secondarily Infected Traumatic Lesions (SITL) · Impetigo

Bottom Line

View on ClinicalTrials.gov: NCT00758862 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: TD1414 Serum Concentration by Timepoint — 624.3; 864.1; 1195.7; 888.4 pg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 2% TD1414 Cream (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LEO Pharma
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY TD1414 Serum Concentration by Timepoint	624.3; 864.1; 1195.7; 888.4; 659.1; 309.0	—
PRIMARY Peak TD1414 Serum Concentration (Cmax )	650.4	—
PRIMARY Peak Serum Concentration by Baseline Lesion Size	484.1; 1233.3	—
PRIMARY Peak Serum Concentration by SIRS Score	416.2; 1068.3	—
PRIMARY Peak Serum Concentration by Amount of TD1414 Cream Used	323.5; 1081.0	—
PRIMARY Time to Reach Peak Serum Concentration (Tmax )	32.08	—
PRIMARY Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size	47.42; 23.73	—
PRIMARY Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score	42.21; 24.22	—
PRIMARY Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used	28.15; 33.65	—
PRIMARY Area Under the Curve (AUC(0-t))	32138	—
PRIMARY Area Under the Curve by Baseline Lesion Size	21240; 78836	—
PRIMARY Area Under the Curve by SIRS Score	17923; 61488	—
PRIMARY Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used	13642; 59932	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00758862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.