Atopic DermatitisNCT03327116
Effect of Methotrexate on Inflammatory Response in Adult Atopic Dermatitis Patients
A study testing Methotrexate in people with Atopic Dermatitis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hepatic and / or renal insufficiency;
- Anemia, thrombocytopenia and / or leukopenia;
- Use of concomitant hepatotoxic drug;
- Active infection;
- Allergy to MTX;
- Excessive alcohol intake;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas of the University of São Paulo Medical School, Department of Dermatology
São Paulo, São Paulo, 05403900
About this study
Official title: Evaluation of the Effect of Methotrexate on Cytokines and Chemokines Involved in the Inflammatory Response in Adult Patients With Atopic Dermatitis
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.
Read the 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 few studies showing its effect on the profile of cytokines involved in the inflammatory response.
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
- Atopic Dermatitis
- Being tested
- Methotrexate
- Keywords
- atopic dermatitis, pruritus, methotrexate, inflamation, IL-31
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
oral, 15 mg per week, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | Not described Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 24
Secondary outcomes (7)
Change from baseline of IgE level at 24 weeks
Nephelometric method
Measured: week 24
Change from baseline of Pruritus at 12 weeks
Visual analogue scale (VAS). The VAS was used as a 10-cm long horizontal line with a starting point as "no itch" (0 points) and ending with "worst imaginable itch".
Measured: week 12
Change from baseline of Pruritus at 24 weeks
Visual analogue scale (VAS). The VAS was used as a 10-cm long horizontal line with a starting point as "no itch" (0 points) and ending with "worst imaginable itch".
Measured: week 24
Change from baseline of SCORAD severity score at 12 weeks
The SCORAD (Scoring atopic dermatitis) is a severity score used for atopic dermatitis.
To measure the extent of AD, the rule of nines is applied on a front/back drawing of the patient's inflammatory lesions. The extent can be graded from 0 to 100.
The intensity part of the SCORAD consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness. Each item can be graded on a scale from 0 to 3.
The subjective items include daily pruritus and sleeplessness. The SCORAD Index formula is: A/5 + 7B/2 + C. In this formula, A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The minimal score of SCORAD is 0 and the maximal score is 103 (most severe).
Measured: week 12
Change from baseline of SCORAD severity score at 24 weeks
The SCORAD (Scoring atopic dermatitis) is a severity score used for atopic dermatitis.
To measure the extent of AD, the rule of nines is applied on a front/back drawing of the patient's inflammatory lesions. The extent can be graded from 0 to 100.
The intensity part of the SCORAD consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness. Each item can be graded on a scale from 0 to 3.
The subjective items include daily pruritus and sleeplessness. The SCORAD Index formula is: A/5 + 7B/2 + C. In this formula, A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The minimal score of SCORAD is 0 and the maximal score is 103 (most severe).
Measured: week 24
Change from baseline of EASI severity score at 12 weeks
Eczema Area and Severity Index (EASI) is a tool for the measurement of severity of atopic dermatitis.
It ranges from 0 (no eczema) to 72 (most severe).
EASI is one of the core outcome instruments recommended to be included in all clinical trials on atopic dermatitis.
Measured: week 12
Change from baseline of EASI severity score at 24 weeks
Eczema Area and Severity Index (EASI) is a tool for the measurement of severity of atopic dermatitis.
It ranges from 0 (no eczema) to 72 (most severe).
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Jul 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- FUNADERSP (Foundation for Research Support of the State of São Paulo)
- Responsible party
- Principal investigator, Valéria Aoki, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327116
- Sponsor's protocol ID
- 13.368
- Status last verified
- Dec 2019
- First submitted
- 30 Jul 2017
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37730501
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Methotrexate on Cytokines and Chemokines Involved in the Inflammatory Response in Adult Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03327116
- Acronym / sponsor ID
- 13.368
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, pruritus, methotrexate, inflamation, IL-31
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- FUNADERSP (Foundation for Research Support of the State of São Paulo)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 few studies showing its effect on the profile of cytokines involved in the inflammatory response.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: Methotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Hepatic and / or renal insufficiency;
- Anemia, thrombocytopenia and / or leukopenia;
- Use of concomitant hepatotoxic drug;
- Active infection;
- Allergy to MTX;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexateoral, 15 mg per week, 24 weeks | Drug | Methotrexate |
Primary outcome
Change from baseline of cytokines and chemokines expression at 24 weeks
Time frame: week 24
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
7 secondary outcomes
Change from baseline of IgE level at 24 weeks
Time frame: week 24
Change from baseline of Pruritus at 12 weeks
Time frame: week 12
Change from baseline of Pruritus at 24 weeks
Time frame: week 24
Change from baseline of SCORAD severity score at 12 weeks
Time frame: week 12
Change from baseline of SCORAD severity score at 24 weeks
Time frame: week 24
Change from baseline of EASI severity score at 12 weeks
Time frame: week 12
Change from baseline of EASI severity score at 24 weeks
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Derived from this study: PubMed 37730501Samorano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate in people with Atopic Dermatitis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of cytokines and chemokines expression at 24 weeks (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03327116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.