Effect of Methotrexate on Inflammatory Response in Adult Atopic Dermatitis Patients

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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 trial with twelve adult patients with moderate to severe AD on methotrexate for 24 weeks.

Investigators intend to evaluate the effect methotrexate on cytokines and chemokines involved in the inflammatory response, on IgE levels, on pruritus, and on EASI and SCORAD severity scores.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Collaborator: FUNADERSP (Foundation for Research Support of the State of São Paulo)
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.