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

NCT ID: NCT01429701

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test association cream

polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Group Type EXPERIMENTAL

polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Intervention Type DRUG

applied 3 times / day at lesion

Comparative association cream

betamethasone + gentamicin + tolnaftato + clioquinol

Group Type ACTIVE_COMPARATOR

betamethasone + gentamicin + tolnaftato + cleoquinol

Intervention Type DRUG

applied 3 times / day at lesion

Interventions

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polymyxin B sulphate + prednisolone + benzocaine + clioquinol

applied 3 times / day at lesion

Intervention Type DRUG

betamethasone + gentamicin + tolnaftato + cleoquinol

applied 3 times / day at lesion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Flávia Addór, MD.

Role: PRINCIPAL_INVESTIGATOR

Medicin Instituto da Pele

Other Identifiers

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PREEMS0711

Identifier Type: -

Identifier Source: org_study_id

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