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Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Impetigo; Secondarily Infected Traumatic Lesions

Intervention: TD1414 2% cream (Drug); TD1414 2% cream (Drug); Bactroban® (mupirocin) 2% cream (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Almena L Free, MD, Principal Investigator, Affiliation: Anniston Medical Clinic

Summary

An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban« (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.

Clinical Details

Official title: Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Clinical cure at end of treatment according to investigator's assessment

Secondary outcome: Clinical cure at follow-up according to investigator's assessment. Clinical cure at end of treatment and follow-up according to investigator's assessment. Bacteriological cure at end of treatment and follow-up.

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed and dated informed consent from patient and/or legally acceptable

representative has been obtained

- Outpatients of any sex or ethnic origin

- Patients >= 2 years of age (depending on study step)

- Patients must be suffering from primary bullous/non-bullous impetigo or SITL

Exclusion Criteria:

- Presence of skin diseases at or near the investigational area

- Immunosuppressed state or other serious systemic disease

- Signs and/or symptoms of systemic infection

- Presence of skin infection/disorder not amenable to topical antibacterial treatment

only

- Presence of secondarily-infected animal/human bite

- Presence of secondarily infected burnwound

- Topical or systemic use of medicinal or other products before or during the study

which in the investigators opinion could confound the evaluation of the effect of the study drugs

- Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414

2% cream

- Known or suspected hypersensitivity to mupirocin or any of the excipients in the

Bactroban® (mupirocin) 2% cream

- Participation in any other investigational drug study or use of (an) investigational

drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation

- Patients previously enrolled/randomised in this study

- Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval

up to 110 ms and the QTc interval up to 450 ms

Locations and Contacts

Anniston Medical Clinic, Anniston, Alabama 36207, United States

Division of Dermatology, Groote Schuur Hospital, G23, Cape Town, Western Cape 7925, South Africa

Additional Information

Starting date: February 2008
Last updated: November 22, 2013

Page last updated: August 23, 2015

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