NCT03327116

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

July 30, 2017

Last Update Submit

December 11, 2019

Conditions

Atopic Dermatitis

Keywords

atopic dermatitispruritusmethotrexateinflamationIL-31

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of cytokines and chemokines expression at 24 weeks

    mRNA expression of IL-4, IL-6, IL-10, IL-31, TSLP, INF-gamma, TNF-alpha, TARC and MDC by Real Time-PCR. Immunohistochemistry with antibodies against IL-31, IL-31RA, OSMR, TSLP and Ki67

    week 24

Secondary Outcomes (7)

  • Change from baseline of IgE level at 24 weeks

    week 24

  • Change from baseline of Pruritus at 12 weeks

    week 12

  • Change from baseline of Pruritus at 24 weeks

    week 24

  • Change from baseline of SCORAD severity score at 12 weeks

    week 12

  • Change from baseline of SCORAD severity score at 24 weeks

    week 24

  • +2 more secondary outcomes

Study Arms (1)

Methotrexate

EXPERIMENTAL
Drug: Methotrexate

Interventions

MethotrexateDRUG

oral, 15 mg per week, 24 weeks

Methotrexate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas of the University of São Paulo Medical School, Department of Dermatology

São Paulo, São Paulo, 05403900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 37730501DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicPruritus

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Director of International Relations

Study Record Dates

First Submitted

July 30, 2017

First Posted

October 31, 2017

Study Start

November 1, 2017

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations

BR(1)