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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ciclosporin |
|
| 2 | Experimental | Methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment | 36 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François Nicolas, Professor | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Lyon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28967549 | Result | 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. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| 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 |
|
| at week 8 and 24 |
| Concentration of cytokines CCL17 and CCL18 | at week 8 and 24 |
| number of adverse events | 36 months |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |