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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: May 2012
Last updated: March 1, 2013
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