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Completed

NCT Number: NCT00809172

Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy.

Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study.

We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospices Civils de Lyon

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged > 18 years old.
  • Both genders eligible for study.
  • Moderate to severe AD.
  • Scorad > 15.
  • Participants must use a contraceptive method during the trial and for 3 months after the end of the trial for female and 5 months for male participants.
  • Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.
  • Patients must be registered in a social security system or with a health insurance coverage.

Exclusion criteria

  • Pregnant or lactating women.
  • Evolutive skin disease.
  • Patients with a clinically significant disease (chronic, recurrent or active).
  • Systemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid the week before the inclusion.
  • Contra-indication to methotrexate and cyclosporine.
  • Exposure to phototherapy: cumulative dose > 2000 J/cm2.
  • Patients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision.
  • Patients under a protection measure.
  • Patients in a critical medical situation.
  • Patients with a personal situation evaluated by the investigator as unable to give optimal participation to the study, or where the study could constitute a risk for the patient.

Treatment and study plan

Ciclosporin

Drug

5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks

methotrexate

Drug

15 mg/week per os in one tablet during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks

Primary outcomes

  1. proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment

    Time frame: 36 months

Secondary outcomes

  1. Decrease of scorad by 50% at week4,12,16,20 and 24

    Time frame: at week4,12,16,20 and 24

  2. Decrease of scorad by 75% and 90 % at week 8 and 24

    Time frame: at week 8 and 24

  3. quality of life at week 8 and 24

    Time frame: at week 8 and 24

  4. Concentration of cytokines CCL17 and CCL18

    Time frame: at week 8 and 24

  5. number of adverse events

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

Acronym: METHODA

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Dec 17, 2008
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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