Status:
COMPLETED
Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Met...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00809172
Start Date
December 1 2008
End Date
April 1 2012
Last Update
September 26 2025
Active Locations (1)
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1
Hospices Civils de Lyon
Lyon, France