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NCT01429701 Clinical Trial

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

Eczema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01429701
Other study ID # PREEMS0711
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2012
Est. completion date August 2012

Study information
Verified date March 2013
Source EMS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date August 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• polymyxin B sulphate + prednisolone + benzocaine + clioquinol
applied 3 times / day at lesion
• betamethasone + gentamicin + tolnaftato + cleoquinol
applied 3 times / day at lesion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
EMS

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction / improvement of signs and symptoms The reduction of signs and symptoms will be evaluated by OSAAD index. DAY 22
Secondary Adverse Events Evaluation Adverse events will be collected and followed in order to evaluate safety and tolerability. DAY 22
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