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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-04-30

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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Ciclosporin

Group Type ACTIVE_COMPARATOR

Ciclosporin

Intervention Type 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

2

Methotrexate

Group Type EXPERIMENTAL

Methotrexate

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No