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Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.

NCT06239311 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2025-08-27

No results posted yet for this study

Summary

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

  • Moderate to Severe Atopic Dermatitis

Interventions

DRUG

Methotrexate

Solution for injection in prefilled pen

DRUG

Placebo

Solution for injection in prefilled pen

Sponsors & Collaborators

  • medac GmbH

    lead INDUSTRY

Principal Investigators

  • Audrey Nosbaum, MD PhD · Université Lyon 1 / INSERM U1111 - CIRI / Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2026-11-30
Completion
2027-04-30

Countries

  • Czechia
  • France
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06239311 on ClinicalTrials.gov