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

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ClinicalTrials.gov Identifier: NCT00626795
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : July 23, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Impetigo Secondarily Infected Traumatic Lesions Drug: TD1414 2% cream Drug: Bactroban® (mupirocin) 2% cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 773 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Study Start Date : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Participants With Clinical Cure According to Investigator's Assessment [ Time Frame: At end of treatment (Day 8) ]

    At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.

    Investigator's assessment of severity of infections (SIRS).

    • Exudates/pus
    • Crusting
    • Erythema
    • Oedema
    • Tissue Warmth
    • Itching
    • Pain

    Each sign/symptoms of infection was assessed by use of the following 4-point scale:

    • 0 = absent
    • 2 = mild
    • 4 = moderate
    • 6 = severe

    The scores were summed up to a total SIRS score.

    Clinical cure was 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 have been ≤4.

    Clinical failure was either of the following:

    • Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure
    • Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).


Secondary Outcome Measures :
  1. Participants With Clinical Cure According to Investigator's Assessment [ Time Frame: At follow up (Day 15) ]
    At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.

  2. Participants With Clinical Cure According to Investigator's Assessment. [ Time Frame: At end of treatment (Day 8) and follow-up (Day 15) ]
    At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.

  3. Participants With Bacteriological Cure According to Bacteriological Samples [ Time Frame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up ]

    At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.

    Bacteriological cure was either of the following:

    • Eradication of the baseline pathogen.
    • Presumed eradication of the baseline pathogen
    • Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.

    Bacteriological failure was any of the following:

    • Documented lack of eradication of the baseline pathogen.
    • Documented relapse (re-infection) with the baseline pathogen
    • Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic
    • Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.

  4. Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples [ Time Frame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up ]

    At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.

    At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based.


  5. Participants With Clinical Cure According to Investigator's Assessment [ Time Frame: At Day 4 ]
    At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626795


Locations
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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
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Principal Investigator: Almena L Free, MD Anniston Medical Clinic
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00626795    
Other Study ID Numbers: TD1414-C21
First Posted: February 29, 2008    Key Record Dates
Results First Posted: July 23, 2018
Last Update Posted: September 10, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action