Actively Recruiting
Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.
Led by medac GmbH · Updated on 2025-08-27
277
Participants Needed
30
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atopic dermatitis is an ongoing condition that causes skin irritation, redness, and itchiness. Treatments are usually topical - applied to the skin (e.g., moisturisers or medicated creams) - but a wider variety of systemic treatments (that target the whole body) are needed for those whose condition does not improve with topical treatments. Methotrexate, a drug approved for similar conditions such as arthritis and psoriasis, has been shown to improve atopic dermatitis. This randomised, controlled clinical trial will investigate how effective.
CONDITIONS
Official Title
Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women of childbearing potential must have a negative pregnancy test at screening and agree to use highly effective contraception during and for 6 months after treatment. Men must agree to use condoms during and for 3 months after treatment and not donate sperm from screening until 3 months post-treatment.
- Diagnosed with atopic dermatitis for at least 12 months according to Hanifin and Rajka criteria.
- Moderate to severe atopic dermatitis with EASI score ≥16, Investigator Global Assessment ≥3, and Dermatology Life Quality Index ≥10 at baseline.
- Eligible for systemic treatment with documented inadequate response to topical corticosteroids or calcineurin inhibitors within 12 months before baseline, or documented systemic treatment for atopic dermatitis.
- Treated with a stable dose of topical emollient for at least 7 consecutive days prior to baseline.
- Chest X-ray without relevant abnormalities within 6 months prior to baseline.
- Able to provide signed informed consent and comply with protocol requirements.
- Covered by health care insurance as per local requirements.
You will not qualify if you...
- Pregnant or breastfeeding women, or planning pregnancy or breastfeeding during the trial.
- Previously treated with methotrexate.
- Known hypersensitivity to methotrexate, folic acid, or any excipients.
- Presence of oral ulcers or active gastrointestinal ulcer disease.
- Blood disorders including low hemoglobin, white blood cell count, or platelet count.
- Liver impairment or elevated liver enzymes and bilirubin, or positive FibrotestTM at screening.
- Drug or alcohol abuse within the past 12 months.
- Renal impairment with creatinine clearance below 60 mL/min.
- Serious acute or chronic infections including tuberculosis, hepatitis B or C, HIV, or other immunodeficiency syndromes.
- Uncontrolled infection or recent hospitalization for infection within 2 months prior to baseline.
- History of malignancy except certain treated skin cancers and cervical carcinoma in situ without recurrence in past 5 years.
- Other skin conditions interfering with atopic dermatitis evaluation.
- Recent treatment with investigational drugs, systemic immunosuppressors, or specific immunotherapies within specified timeframes before baseline.
- Recent treatment with live vaccines or planned live vaccination during the trial.
- Planned surgery during the trial.
- Clinically significant uncontrolled medical disease or any condition interfering with assessment or increasing participant risk.
- Legal or custodial restrictions preventing participation, including guardianship, institutionalization, incarceration, or mandatory military service.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 30 locations
1
MU Dr. Petr Arenberger, DrSc. MBA
Prague, Praha 1, Czechia, 11000
Actively Recruiting
2
Synexus Czech s.r.o.
Prague, Praha 2, Czechia, 12000
Terminated
3
Praglandia s.r.o.
Prague, Praha 5, Czechia, 15000
Actively Recruiting
4
AGE Centrum s.r.o.
Olomouc, Czechia, 77900
Withdrawn
5
CCR Ostrava s.r.o,
Ostrava, Czechia, 702 00
Actively Recruiting
6
CCR Czech Pardubice a.s.
Pardubice, Czechia, 53000
Actively Recruiting
7
Clintrial s.r.o.
Prague, Czechia, 10000
Actively Recruiting
8
Dermatology clinic MUDr. Blanka Havlickova
Prague, Czechia, 11000
Actively Recruiting
9
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
Bordeaux, France, 33075
Withdrawn
10
Centre Hospitalier universitaire (CHU) de Clermont Ferrand Hopital d'Estaing
Clermont-Ferrand, France, 63003
Withdrawn
11
Centre Hospitalier Universitaire De Nantes
Nantes, France, 44093
Withdrawn
12
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
Actively Recruiting
13
Ospedale San Donato di Arezzo
Arezzo, Italy, 52100
Actively Recruiting
14
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant' Anna
Ferrara, Italy, 44124
Withdrawn
15
Ospedale Piero Palagi
Florence, Italy, 50125
Withdrawn
16
Universita degli Studi della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria
Naples, Italy, 80138
Withdrawn
17
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Withdrawn
18
Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa, Italy, 56126
Actively Recruiting
19
Synexus Polska Sp. z o.o. in Czestochowa
Częstochowa, Poland, 42-202
Actively Recruiting
20
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Poland, 80-382
Actively Recruiting
21
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, Poland, 40-040
Actively Recruiting
22
Angelius Badania Kliniczne
Katowice, Poland, 40-611
Actively Recruiting
23
Synexus Polska Sp. z. o.o. Oddzial W Lodzi
Lodz, Poland, 90-127
Actively Recruiting
24
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
Lublin, Poland, 20-573
Actively Recruiting
25
Klinika Zdybski
Lublin, Poland, 20-607
Actively Recruiting
26
Twoja Klinika
Mikołów, Poland, 43-190
Actively Recruiting
27
Synexus Polska Sp z o.o. Oddzial W Poznaniu
Poznan, Poland, 60-702
Actively Recruiting
28
Laser Clinic
Szczecin, Poland, 70-332
Actively Recruiting
29
Synexus Polska Sp. Z o.o. Odział w Warszawie
Warsaw, Poland, 02-672
Actively Recruiting
30
Klinika Ambroziak Dermatologia
Warsaw, Poland, 02-953
Withdrawn
Research Team
M
Medac Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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