Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients - Full Text View

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00809172

Purpose

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.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Ciclosporin Drug: Methotrexate	Phase III

MedlinePlus related topics: Hospice Care

Drug Information available for: Methotrexate Cyclosporine Cyclosporin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decrease of scorad by 50% at week4,12,16,20 and 24 [ Time Frame: at week4,12,16,20 and 24 ] [ Designated as safety issue: No ]
Decrease of scorad by 75% and 90 % at week 8 and 24 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
quality of life at week 8 and 24 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
Concentration of cytokines CCL17 and CCL18 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
number of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ciclosporin	Drug: 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
2: Experimental Methotrexate	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809172

Contacts

Contact: Catherine Goujon-Henry, MD

00 33 4 78 86 41 25

catherine.goujon-henry@chu-lyon.fr

Locations

France
Hospices Civils De Lyon	Recruiting
LYON, France
Contact: Jean-François Nicolas, Professor. 00 33 4 78 86 15 72 jean-francois.nicolas@chu-lyon.fr

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Jean-François Nicolas, Professor

Hospices Civils de Lyon

More Information

No publications provided

Responsible Party:	Organization: Hospices Civils de Lyon ( Jean-François Nicolas, Professor. )
Study ID Numbers:	2007.476
Study First Received:	December 16, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809172 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Atopic-dermatitis
scorad
methotrexate
ciclosporin

Study placed in the following topic categories:

Antimetabolites
Dermatitis, Atopic
Cyclosporine
Skin Diseases
Immunologic Factors
Clotrimazole
Miconazole
Tioconazole
Folic Acid Antagonists
Cyclosporins
Immunosuppressive Agents

Folic Acid
Hypersensitivity
Genetic Diseases, Inborn
Antifungal Agents
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Methotrexate
Antirheumatic Agents
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Cyclosporine
Dermatitis, Atopic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Cyclosporins
Hypersensitivity
Antifungal Agents
Therapeutic Uses
Abortifacient Agents

Methotrexate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Dermatitis
Immune System Diseases
Skin Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Genetic Diseases, Inborn
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 07, 2009