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

EMS

Status and phase: Completed; Phase 3

Conditions: Eczema

Treatments: Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol; Drug: betamethasone + gentamicin + tolnaftato + cleoquinol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01429701

PREEMS0711

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups

Test association cream

Experimental group

Description:

polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Treatment:

Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Comparative association cream

Active Comparator group

Description:

betamethasone + gentamicin + tolnaftato + clioquinol

Treatment:

Drug: betamethasone + gentamicin + tolnaftato + cleoquinol