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

Study Overview
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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.

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

Conditions
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Eczema

Intervention / Treatment
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* Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol
* Drug: betamethasone + gentamicin + tolnaftato + cleoquinol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction / improvement of signs and symptoms | 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 | Adverse events will be collected and followed in order to evaluate safety and tolerability. | DAY 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Dermatitis, Atopic