Clinical trial NCT00809172: Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
Official title: Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic-dermatitis
scorad
methotrexate
ciclosporin
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2008-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment
timeFrame: 36 months
Secondary outcomes:
measure: Decrease of scorad by 50% at week4,12,16,20 and 24
timeFrame: at week4,12,16,20 and 24
measure: Decrease of scorad by 75% and 90 % at week 8 and 24
timeFrame: at week 8 and 24
measure: quality of life at week 8 and 24
timeFrame: at week 8 and 24
measure: Concentration of cytokines CCL17 and CCL18
timeFrame: at week 8 and 24
measure: number of adverse events
timeFrame: 36 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-François Nicolas, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.