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

Overview

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.

Full Title of Study: “Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2012

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.

Interventions

  • Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol
    • applied 3 times / day at lesion
  • Drug: betamethasone + gentamicin + tolnaftato + cleoquinol
    • applied 3 times / day at lesion

Arms, Groups and Cohorts

  • Experimental: Test association cream
    • polymyxin B sulphate + prednisolone + benzocaine + clioquinol
  • Active Comparator: Comparative association cream
    • betamethasone + gentamicin + tolnaftato + clioquinol

Clinical Trial Outcome Measures

Primary Measures

  • Reduction / improvement of signs and symptoms
    • Time Frame: DAY 22
    • The reduction of signs and symptoms will be evaluated by OSAAD index.

Secondary Measures

  • Adverse Events Evaluation
    • Time Frame: DAY 22
    • Adverse events will be collected and followed in order to evaluate safety and tolerability.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMS
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Flávia Addór, MD., Principal Investigator, Medicin Instituto da Pele

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