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

Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Eczema

Intervention: polymyxin B sulphate + prednisolone + benzocaine + clioquinol (Drug); betamethasone + gentamicin + tolnaftato + cleoquinol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: EMS

Official(s) and/or principal investigator(s):
Flávia Addór, MD., Principal Investigator, Affiliation: Medicin Instituto da Pele


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction / improvement of signs and symptoms

Secondary outcome: Adverse Events Evaluation

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.


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: May 2012
Last updated: March 1, 2013

Page last updated: August 23, 2015

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