Methotrexate Injections for Psoriasis

Overseen By Shari Lipner, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must not be taking: Immunosuppressants, Oral corticosteroids

Disqualifiers: Immunodeficiency, Onychomycosis, Renal impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 13 weeks

10 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial requires that you stop any systemic treatment for psoriasis and any substances that significantly interact with the study drugs. It also mentions a washout period (time without taking certain medications) if applicable, but does not specify the details.

What data supports the effectiveness of the drug methotrexate for treating psoriasis?

Research shows that methotrexate is a well-established and effective treatment for moderate-to-severe psoriasis, especially when given as subcutaneous injections, which are more predictable and effective than oral doses. It is considered a first-line therapy and can delay the need for more expensive treatments. ^{1 2 3 4 5}

Is methotrexate safe for treating psoriasis?

Methotrexate has been used for over 50 years to treat psoriasis and is generally safe when used in low doses according to guidelines. However, it can cause side effects like liver damage and blood cell issues, especially if not dosed correctly. ^{6 7 8 9 10}

How is the drug methotrexate unique for treating psoriasis?

Methotrexate injections for psoriasis are unique because they can be self-administered at home using prefilled syringes, offering a more predictable absorption compared to oral methotrexate, which can vary between individuals and cause stomach issues. This method can be more effective and may delay the need for more expensive treatments. ^{3 8 11 12 13}

What is the purpose of this trial?

The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis.

Research Team

Shari Lipner, MD,PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for individuals with nail psoriasis. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements on who can participate.

Inclusion Criteria

I have been diagnosed with nail psoriasis in at least 3 of my fingernails.

Exclusion Criteria

I haven't had radiation, chemotherapy, immunosuppressants, or certain steroids in the last 6 months.

I agree not to use any nail treatments other than what the study provides.

Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intralesional injections (methotrexate, triamcinolone acetonide, or placebo) into 1 nail bed/nail matrix every 6 weeks for 3 sessions

13 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

2 visits (in-person)

Treatment Details

Interventions

• Methotrexate

Trial Overview The trial aims to test the effectiveness of methotrexate injections compared to saline (a placebo) and triamcinolone acetonide (a steroid) in treating nail psoriasis.

Participant Groups

Group I: Intralesional Methotrexate Experimental Treatment 1 Intervention

Participants receive intralesional methotrexate injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.

Group II: Intralesional Triamcinolone Acetonide Active Control 1 Intervention

Participants receive intralesional triamcinolone acetonide injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.

Group III: Intralesional Placebo (saline) Placebo Group 1 Intervention

Participants receive intralesional saline injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.

Methotrexate is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Trexall for:

• Acute lymphoblastic leukemia
• Non-Hodgkin's lymphoma
• Osteosarcoma
• Breast cancer
• Lung cancer
• Head and neck cancer
• Psoriasis
• Rheumatoid arthritis

Approved in Canada as Mexate for:

• Acute lymphoblastic leukemia
• Non-Hodgkin's lymphoma
• Osteosarcoma
• Breast cancer
• Lung cancer
• Head and neck cancer
• Psoriasis
• Rheumatoid arthritis

Approved in European Union as Methotrexate for:

• Acute lymphoblastic leukemia
• Non-Hodgkin's lymphoma
• Osteosarcoma
• Breast cancer
• Lung cancer
• Head and neck cancer
• Psoriasis
• Rheumatoid arthritis
• Crohn's disease
• Ulcerative colitis

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

References

1. Spain pubmed.ncbi.nlm.nih.gov

Guidelines on the Use of Methotrexate in Psoriasis. [2019]

2. Spain pubmed.ncbi.nlm.nih.gov

[Guidelines on the use of methotrexate in psoriasis]. [2018]

3. Poland pubmed.ncbi.nlm.nih.gov

[Subcutaneous methotrexate in psoriasis and psoriatic arthritis treatment]. [2017]

4. Spain pubmed.ncbi.nlm.nih.gov

Methotrexate: new therapeutic approaches. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Intra-articular methotrexate. Clinical and laboratory study in rheumatoid and psoriatic arthritis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Dermatological guidelines for monitoring methotrexate treatment reduce drug-survival compared to rheumatological guidelines. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Methotrexate in psoriasis: 26 years' experience with low-dose long-term treatment. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials. [2018]

9. France pubmed.ncbi.nlm.nih.gov

[Methotrexate and psoriasis]. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Fatal Manifestations of Methotrexate Overdose in Case of Psoriasis Due to Dosing Error. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Patient-ready syringes containing 25 mg/mL methotrexate can be kept at temperature ranging from 4 °C to 37 °C for up to 12 weeks for use in psoriatic and rheumatologic conditions. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis: First-Year Results of a Single-Blind Randomized Controlled Trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Folate supplementation reduces the side effects of methotrexate therapy for psoriasis. [2014]