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
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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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2012-05-31
2012-08-31
Brief Summary
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Detailed Description
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* 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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test association cream
polymyxin B sulphate + prednisolone + benzocaine + clioquinol
polymyxin B sulphate + prednisolone + benzocaine + clioquinol
applied 3 times / day at lesion
Comparative association cream
betamethasone + gentamicin + tolnaftato + clioquinol
betamethasone + gentamicin + tolnaftato + cleoquinol
applied 3 times / day at lesion
Interventions
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polymyxin B sulphate + prednisolone + benzocaine + clioquinol
applied 3 times / day at lesion
betamethasone + gentamicin + tolnaftato + cleoquinol
applied 3 times / day at lesion
Eligibility Criteria
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Inclusion Criteria
2. Patients with acute or subacute dermatitis with a minimum of 3 symptoms.
Exclusion Criteria
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.
18 Years
40 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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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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