NCT00809172

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2008

Typical duration for phase_3

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

Study Start

First participant enrolled

December 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 26, 2025

Status Verified

October 1, 2009

Enrollment Period

2.8 years

First QC Date

December 16, 2008

Last Update Submit

September 23, 2025

Conditions

Atopic Dermatitis

Keywords

Atopic-dermatitisscoradmethotrexateciclosporin

Outcome Measures

Primary Outcomes (1)

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

    36 months

Secondary Outcomes (5)

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

    at week4,12,16,20 and 24

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

    at week 8 and 24

  • quality of life at week 8 and 24

    at week 8 and 24

  • Concentration of cytokines CCL17 and CCL18

    at week 8 and 24

  • number of adverse events

    36 months

Study Arms (2)

1

ACTIVE COMPARATOR

Ciclosporin

Drug: Ciclosporin

2

EXPERIMENTAL

Methotrexate

Drug: Methotrexate

Interventions

CiclosporinDRUG

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

1
MethotrexateDRUG

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

2

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or lactating women.
  • Evolutive skin disease.
  • Patients with a clinically significant disease (chronic, recurrent or active).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

Related Publications (1)

  • Goujon C, Viguier M, Staumont-Salle D, Bernier C, Guillet G, Lahfa M, Ferrier Le Bouedec MC, Cambazard F, Bottigioli D, Grande S, Dahel K, Berard F, Rabilloud M, Mercier C, Nicolas JF. Methotrexate Versus Cyclosporine in Adults with Moderate-to-Severe Atopic Dermatitis: A Phase III Randomized Noninferiority Trial. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):562-569.e3. doi: 10.1016/j.jaip.2017.07.007. Epub 2017 Sep 28.

    PMID: 28967549RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

CyclosporineMethotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jean-François Nicolas, Professor

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2011

Study Completion

April 1, 2012

Last Updated

September 26, 2025

Record last verified: 2009-10

Locations

FR(1)