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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Ciclosporin
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ciclosporin | Drug: Ciclosporin<br>* 5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks<br>|
| Experimental: 2<br>Methotrexate | Drug: Methotrexate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic-dermatitis, scorad, methotrexate, ciclosporin