Atopic DermatitisPhase 3METHODANCT00809172
Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
A Phase 3 study testing Ciclosporin and Methotrexate in people with Atopic Dermatitis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ciclosporin and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Ciclosporin, Methotrexate
- Keywords
- Atopic-dermatitis, scorad, methotrexate, ciclosporin
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclosporinDrug
5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks
MethotrexateDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ciclosporin Receives: Drug: Ciclosporin |
| 2 | Experimental | Methotrexate Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment
Measured: 36 months
Secondary outcomes (5)
Decrease of scorad by 50% at week4,12,16,20 and 24
Measured: at week4,12,16,20 and 24
Decrease of scorad by 75% and 90 % at week 8 and 24
Measured: at week 8 and 24
quality of life at week 8 and 24
Measured: at week 8 and 24
Concentration of cytokines CCL17 and CCL18
Measured: at week 8 and 24
number of adverse events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François Nicolas, Professor, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809172
- Sponsor's protocol ID
- 2007.476
- Acronym
- METHODA
- Status last verified
- Oct 2009
- First submitted
- 16 Dec 2008
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28967549
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT00809172
- Acronym / sponsor ID
- METHODA / 2007.476
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic-dermatitis, scorad, methotrexate, ciclosporin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CiclosporinCiclosporin |
| 2 | Experimental | Drug: MethotrexateMethotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciclosporin5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks | Drug | 1 |
| Methotrexate15 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 | Drug | 2 |
Primary outcome
proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment
Time frame: 36 months
5 secondary outcomes
Decrease of scorad by 50% at week4,12,16,20 and 24
Time frame: at week4,12,16,20 and 24
Decrease of scorad by 75% and 90 % at week 8 and 24
Time frame: at week 8 and 24
quality of life at week 8 and 24
Time frame: at week 8 and 24
Concentration of cytokines CCL17 and CCL18
Time frame: at week 8 and 24
number of adverse events
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Results publication: PubMed 28967549Goujon 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Nicolas, Professor principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciclosporin and Methotrexate in people with Atopic Dermatitis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.