Status:
COMPLETED
Effect of Methotrexate on Inflammatory Response in Adult Atopic Dermatitis Patients
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
FUNADERSP (Foundation for Research Support of the State of São Paulo)
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with pruritus. Methotrexate can be used to treat refractory disease to conventional therapy. It will be conducted a single arm...
Detailed Description
Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with pruritus. Methotrexate (MTX) can be used to treat refractory disease to conventional therapy, but there are ...
Eligibility Criteria
Inclusion
- AD (Hanifin and Rajka criteria) moderate to severe (EASI ≥ 7.1 and SCORAD ≥ 25);
- Age ≥ 18 years;
- Women without the potential to become pregnant or using an effective method of contraception and with a negative pregnancy blood test;
- Men without a desire of pregnancy and who use condom in sexual intercourse.
Exclusion
- Hepatic and / or renal insufficiency;
- Anemia, thrombocytopenia and / or leukopenia;
- Use of concomitant hepatotoxic drug;
- Active infection;
- Allergy to MTX;
- Excessive alcohol intake;
- Difficulty to understand how to take methotrexate;
- HIV infection or other immunosuppression condition;
- Therapy with UVA or UVB, corticoid, cyclosporine, immunobiological, azathioprine within 12 weeks prior to introduction of methotrexate.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03327116
Start Date
November 1 2017
End Date
December 1 2018
Last Update
December 13 2019
Active Locations (1)
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1
Hospital das Clínicas of the University of São Paulo Medical School, Department of Dermatology
São Paulo, São Paulo, Brazil, 05403900