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

September 5, 2011
March 1, 2013
May 2012
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01429701 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + 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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Eczema
  • Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol
    applied 3 times / day at lesion
  • Drug: betamethasone + gentamicin + tolnaftato + cleoquinol
    applied 3 times / day at lesion
  • Experimental: Test association cream
    polymyxin B sulphate + prednisolone + benzocaine + clioquinol
    Intervention: Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol
  • Active Comparator: Comparative association cream
    betamethasone + gentamicin + tolnaftato + clioquinol
    Intervention: Drug: betamethasone + gentamicin + tolnaftato + cleoquinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
August 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01429701
PREEMS0711
Yes
EMS
EMS
Not Provided
Principal Investigator: Flávia Addór, MD. Medicin Instituto da Pele
EMS
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP