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

February 23, 2021 updated by: EMS

Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test association cream
polymyxin B sulphate + prednisolone + benzocaine + clioquinol
Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol
applied 3 times / day at lesion
Active Comparator: Comparative association cream
betamethasone + gentamicin + tolnaftato + clioquinol
Drug: betamethasone + gentamicin + tolnaftato + cleoquinol
applied 3 times / day at lesion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Investigators

  • Principal Investigator: Flávia Addór, MD., Medicin Instituto da Pele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 5, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREEMS0711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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