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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01429701
First received: September 5, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Eczema
 Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol
Drug: betamethasone + gentamicin + tolnaftato + cleoquinol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Eczema
U.S. FDA Resources

Further study details as provided by EMS:

Primary Outcome Measures:
  • Reduction / improvement of signs and symptoms [ Time Frame: DAY 22 ] [ Designated as safety issue: No ]
    The reduction of signs and symptoms will be evaluated by OSAAD index.


Secondary Outcome Measures:
  • Adverse Events Evaluation [ Time Frame: DAY 22 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability.


Enrollment: 76
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429701

Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Flávia Addór, MD. Medicin Instituto da Pele
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01429701     History of Changes
Other Study ID Numbers: PREEMS0711
Study First Received: September 5, 2011
Last Updated: March 1, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
Dermatitis
Dermatitis, Atopic

Additional relevant MeSH terms:
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous
Polymyxin B
Gentamicins
Polymyxins
Benzocaine
Methylprednisolone
Methylprednisolone Hemisuccinate
Betamethasone-17,21-dipropionate
Methylprednisolone acetate
Prednisolone acetate
Betamethasone
Prednisolone
 Betamethasone sodium phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013