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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00809172
First received: December 16, 2008
Last updated: May 13, 2013
Last verified: October 2009

December 16, 2008
May 13, 2013
December 2008
October 2011   (final data collection date for primary outcome measure)
proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00809172 on ClinicalTrials.gov Archive Site
  • Decrease of scorad by 50% at week4,12,16,20 and 24 [ Time Frame: at week4,12,16,20 and 24 ] [ Designated as safety issue: No ]
  • Decrease of scorad by 75% and 90 % at week 8 and 24 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
  • quality of life at week 8 and 24 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
  • Concentration of cytokines CCL17 and CCL18 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
  • number of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
Multicenter Randomised 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: Ciclosporin
    5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks
  • Drug: Methotrexate
    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
  • Active Comparator: 1
    Ciclosporin
    Intervention: Drug: Ciclosporin
  • Experimental: 2
    Methotrexate
    Intervention: Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00809172
2007.476
No
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Jean-François Nicolas, Professor Hospices Civils de Lyon
Hospices Civils de Lyon
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP