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Completed

NCT Number: NCT01429701

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

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.

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Key information

Conditions

Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Drug

applied 3 times / day at lesion

betamethasone + gentamicin + tolnaftato + cleoquinol

Drug

applied 3 times / day at lesion

Primary outcomes

  1. Reduction / improvement of signs and symptoms

    Time frame: DAY 22

    The reduction of signs and symptoms will be evaluated by OSAAD index.

Secondary outcomes

  1. Adverse Events Evaluation

    Time frame: DAY 22

    Adverse events will be collected and followed in order to evaluate safety and tolerability.

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2011
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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