Effectiveness of Polymixin B Sulphate + Prednisolone + Benzoacaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
Information source: EMS
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eczema
Intervention: polymixin B sulphate + prednisolone + benzoacaine + clioquinol (Drug); bethametasone + gentamicine + tolnaftato + cleoquinol (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: EMS Official(s) and/or principal investigator(s):
Flávia Addór, MD., Principal Investigator, Affiliation: Medicin Instituto da Pele
Overall contact:
Felipe Pinho, MD, Phone: 55 19 38879433, Email: felipe.pinho@ems.com.br
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 propose of this trial is evaluate the effectiveness of two differents topic
associations of drugs.
Clinical Details
Official title: Unicentric Comparing Effectiveness of Polymixin B Sulphate + Prednisolone + Benzoacaine + Clioquinol to Bethametasone + Gentamicin + Tolnaftate + Cleoquinol 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 sub-acute dermatitis with minimun 3 symptons.
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
Felipe Pinho, MD, Phone: 55 19 38879433, Email: felipe.pinho@ems.com.br Additional Information
Starting date: April 2012
Last updated: September 6, 2011
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