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

Phase 3

Completed

• Conditions: Eczema
• Interventions: Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol; Drug: betamethasone + gentamicin + tolnaftato + cleoquinol

• Registration Number: NCT01429701
• Lead Sponsor: EMS

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.

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 Timeline

• Study First Submitted: 2011-09-05
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Study Start: 2012-05
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-03
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with acute or subacute dermatitis with a minimum of 3 symptoms.

Exclusion Criteria

1. Pregnancy or risk of pregnancy.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test association cream	polymyxin B sulphate + prednisolone + benzocaine + clioquinol	polymyxin B sulphate + prednisolone + benzocaine + clioquinol
Comparative association cream	betamethasone + gentamicin + tolnaftato + cleoquinol	betamethasone + gentamicin + tolnaftato + clioquinol

Primary Outcome Measures

Name	Time	Method
Reduction / improvement of signs and symptoms	DAY 22	The reduction of signs and symptoms will be evaluated by OSAAD index.

Secondary Outcome Measures

Name	Time	Method
Adverse Events Evaluation	DAY 22	Adverse events will be collected and followed in order to evaluate safety and tolerability.