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

Sponsor:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00626795

Purpose

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.

Condition	Intervention	Phase
Impetigo Secondarily Infected Traumatic Lesions	Drug: TD1414 2% cream Drug: Bactroban® (mupirocin) 2% cream	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Resource links provided by NLM:

MedlinePlus related topics: Impetigo

Drug Information available for: Mupirocin Mupirocin calcium

U.S. FDA Resources

Further study details as provided by LEO Pharma:

Primary Outcome Measures:

Clinical cure at end of treatment according to investigator's assessment [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]
Investigator's assessment of severity of infections (SIRS).
- Exudates/pus
- Crusting
- Erythema
- Oedema
- Tissue Warmth
- Itching
- Pain

Secondary Outcome Measures:

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. [ Time Frame: At Visit 2, at follow up, at end of treatment ] [ Designated as safety issue: Yes ]
Investigator's assessment of severity of infections (SIRS).
- Exudates/pus
- Crusting
- Erythema
- Oedema
- Tissue Warmth
- Itching
- Pain
Clinical cure will be either of the following:
- Total absence of signs and symptoms of impetigo/SITL or
- Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should be ≤ 4
Bacteriological cure will be:
- Documented eradication
- Presumed eradication
- Documented infection with a pathogen different from the baseline pathogen, and the pateient is NOT symptomatic.

Enrollment:	682
Study Start Date:	February 2008
Study Completion Date:	June 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: TD1414 2% cream BID 7 days
Experimental: 2	Drug: TD1414 2% cream TID 7 days
Active Comparator: 3	Drug: Bactroban® (mupirocin) 2% cream BID 7 days

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626795

Locations

United States, Alabama
Anniston Medical Clinic
Anniston, Alabama, United States, 36207
South Africa
Division of Dermatology, Groote Schuur Hospital, G23
Cape Town, Western Cape, South Africa, 7925

Sponsors and Collaborators

LEO Pharma

Investigators

Principal Investigator:

Almena L Free, MD

Anniston Medical Clinic

More Information

No publications provided

Responsible Party:	Birgitte Vestbjerg / International Clinical Trial Manager, LEO Pharma A/S
ClinicalTrials.gov Identifier:	NCT00626795 History of Changes
Other Study ID Numbers:	TD1414-C21
Study First Received:	February 21, 2008
Last Updated:	March 5, 2010
Health Authority:	United States: Food and Drug Administration; South Africa: Medicines Control Council

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
Mupirocin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012