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Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous

Primary Purpose

Eczema

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
polymyxin B sulphate + prednisolone + benzocaine + clioquinol
betamethasone + gentamicin + tolnaftato + cleoquinol
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema focused on measuring Dermatitis, Dermatitis, Atopic

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must be able to understand the study procedures agree to participate and give written consent.
  2. Patients with acute or subacute dermatitis with a minimum of 3 symptoms.

Exclusion Criteria:

  1. Pregnancy or risk of pregnancy.
  2. Lactation
  3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
  4. Sunlight over exposure in the last 15 days.
  5. Any pathology or past medical condition that can interfere with this protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test association cream

    Comparative association cream

    Arm Description

    polymyxin B sulphate + prednisolone + benzocaine + clioquinol

    betamethasone + gentamicin + tolnaftato + clioquinol

    Outcomes

    Primary Outcome Measures

    Reduction / improvement of signs and symptoms
    The reduction of signs and symptoms will be evaluated by OSAAD index.

    Secondary Outcome Measures

    Adverse Events Evaluation
    Adverse events will be collected and followed in order to evaluate safety and tolerability.

    Full Information

    First Posted
    September 5, 2011
    Last Updated
    February 23, 2021
    Sponsor
    EMS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01429701
    Brief Title
    Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
    Official Title
    Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    August 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMS

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The purpose of this trial is evaluate the effectiveness of two different topic associations of drugs.
    Detailed Description
    Study design: Experiment duration: 22 days 2 visits (days 0,7,15 and 22) Reducing eczema area and severity index evaluation Adverse events evaluation Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eczema
    Keywords
    Dermatitis, Dermatitis, Atopic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test association cream
    Arm Type
    Experimental
    Arm Description
    polymyxin B sulphate + prednisolone + benzocaine + clioquinol
    Arm Title
    Comparative association cream
    Arm Type
    Active Comparator
    Arm Description
    betamethasone + gentamicin + tolnaftato + clioquinol
    Intervention Type
    Drug
    Intervention Name(s)
    polymyxin B sulphate + prednisolone + benzocaine + clioquinol
    Intervention Description
    applied 3 times / day at lesion
    Intervention Type
    Drug
    Intervention Name(s)
    betamethasone + gentamicin + tolnaftato + cleoquinol
    Intervention Description
    applied 3 times / day at lesion
    Primary Outcome Measure Information:
    Title
    Reduction / improvement of signs and symptoms
    Description
    The reduction of signs and symptoms will be evaluated by OSAAD index.
    Time Frame
    DAY 22
    Secondary Outcome Measure Information:
    Title
    Adverse Events Evaluation
    Description
    Adverse events will be collected and followed in order to evaluate safety and tolerability.
    Time Frame
    DAY 22

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must be able to understand the study procedures agree to participate and give written consent. Patients with acute or subacute dermatitis with a minimum of 3 symptoms. Exclusion Criteria: Pregnancy or risk of pregnancy. Lactation Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study). Sunlight over exposure in the last 15 days. Any pathology or past medical condition that can interfere with this protocol.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Flávia Addór, MD.
    Organizational Affiliation
    Medicin Instituto da Pele
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous

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