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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00626795
First received: February 21, 2008
Last updated: November 22, 2013
Last verified: November 2013
  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 2

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:


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
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: 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: LEO Pharma
ClinicalTrials.gov Identifier: NCT00626795     History of Changes
Other Study ID Numbers: TD1414-C21
Study First Received: February 21, 2008
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

Additional relevant MeSH terms:
Impetigo
Bacterial Infections
Gram-Positive Bacterial Infections
Infection
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Staphylococcal Infections
Staphylococcal Skin Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on November 20, 2014