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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.
Study design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test association cream | Experimental | polymyxin B sulphate + prednisolone + benzocaine + clioquinol |
|
| Comparative association cream | Active Comparator | betamethasone + gentamicin + tolnaftato + clioquinol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polymyxin B sulphate + prednisolone + benzocaine + clioquinol | Drug | applied 3 times / day at lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction / improvement of signs and symptoms | The reduction of signs and symptoms will be evaluated by OSAAD index. | DAY 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Evaluation | Adverse events will be collected and followed in order to evaluate safety and tolerability. | DAY 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flávia Addór, MD. | Medicin Instituto da Pele | Principal Investigator |
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| betamethasone + gentamicin + tolnaftato + cleoquinol | Drug | applied 3 times / day at lesion |
|
| ID | Term |
|---|---|
| D004485 | Eczema |
| D003872 | Dermatitis |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011112 | Polymyxin B |
| D011239 | Prednisolone |
| D001566 | Benzocaine |
| D007464 | Clioquinol |
| D001623 | Betamethasone |
| D005839 | Gentamicins |
| D014047 | Tolnaftate |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D015125 | Oxyquinoline |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013859 | Thiocarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D013457 | Sulfur Compounds |
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