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

Sponsor

EMS (Industry)

Overall Status

Completed

CT.gov ID

NCT01429701

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eczema	Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol Drug: betamethasone + gentamicin + tolnaftato + cleoquinol	Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test association cream polymyxin B sulphate + prednisolone + benzocaine + clioquinol	Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol applied 3 times / day at lesion
Active Comparator: Comparative association cream betamethasone + gentamicin + tolnaftato + clioquinol	Drug: betamethasone + gentamicin + tolnaftato + cleoquinol applied 3 times / day at lesion

Arm

Intervention/Treatment

Experimental: Test association cream

polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol

applied 3 times / day at lesion

Active Comparator: Comparative association cream

betamethasone + gentamicin + tolnaftato + clioquinol

Drug: betamethasone + gentamicin + tolnaftato + cleoquinol

applied 3 times / day at lesion

Outcome Measures

Primary Outcome Measures

Reduction / improvement of signs and symptoms [DAY 22]
The reduction of signs and symptoms will be evaluated by OSAAD index.

Secondary Outcome Measures

Adverse Events Evaluation [DAY 22]
Adverse events will be collected and followed in order to evaluate safety and tolerability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.