Effect of Methotrexate on Inflammatory Response in Adult Atopic Dermatitis Patients
NCT ID: NCT03327116
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2017-11-01
2018-12-01
Brief Summary
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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.
Detailed Description
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Objectives: To assess the effect of MTX on the cytokines involved in the inflammatory response of adult AD patients treated with methotrexate for 24 weeks. As specific objectives, investigators intend to assess the evolution of serum IgE levels, the EASI (Eczema Area and Severity Index) and SCORAD (Scoring Atopic Dermatitis) severity scores and pruritus in them.
Methods: It will be conducted an open, prospective study with twelve adult patients with moderate to severe AD on MTX for 24 weeks. Each participant is expected to attend 7 visits during 6 months of follow-up. In clinical healthy and injured skin, two assessments will be performed: 1) mRNA expression of IL-4, IL-10, IL-17A, IL-22, IL-31, oncostatin M receptor (OSMR), alpha subunit IL-31 (IL-31RA) receptor, TNF-α, IFN-γ, TSLP, TARC and MDC by Real Time-PCR at the initial week and week 24; 2) expression of IL-31, IL-31RA, OSMR, TSLP and Ki67 by immunohistochemistry at the initial week and week 24.
Skin samples from non-atopic subjects will be utilized as controls for the assays, paired by gender and age.
Additional analysis of serum levels of IgE (nephelometric method) at the initial week and week 24 of the study will be performed.
AD severity scores (EASI and SCORAD) will be tested and pruritus will be analyzed by a visual analog scale at the initial, week 12 and week 24.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Methotrexate
Methotrexate
oral, 15 mg per week, 24 weeks
Interventions
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Methotrexate
oral, 15 mg per week, 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
FUNADERSP (Foundation for Research Support of the State of São Paulo)
UNKNOWN
Responsible Party
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Valéria Aoki
Associate Professor and Director of International Relations
Locations
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Hospital das Clínicas of the University of São Paulo Medical School, Department of Dermatology
São Paulo, São Paulo, Brazil
Countries
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References
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Samorano LP, Manfrere KCG, Pereira NV, Takaoka R, Valente NYS, Sotto MN, Silva LFF, Sato MN, Aoki V. Methotrexate for refractory adult atopic dermatitis leads to alterations in cutaneous IL-31 and IL-31RA expression. An Bras Dermatol. 2024 Jan-Feb;99(1):72-79. doi: 10.1016/j.abd.2023.01.002. Epub 2023 Sep 18.
Other Identifiers
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13.368
Identifier Type: -
Identifier Source: org_study_id