Trial | NCT01429701  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    76
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:

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 Started
May 31
2012
Primary Completion
Jun 30
2012
Study Completion
Aug 31
2012
Last Update
Feb 24
2021

Drug polymyxin B sulphate + prednisolone + benzocaine + clioquinol

applied 3 times / day at lesion

Drug betamethasone + gentamicin + tolnaftato + cleoquinol

applied 3 times / day at lesion

Test association cream Experimental

polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Comparative association cream Active Comparator

betamethasone + gentamicin + tolnaftato + clioquinol

Criteria 

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.
No Results Posted