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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of methotrexate injections for treating nail psoriasis, a condition that causes nail discoloration and thickening. Participants will receive injections directly into the nail area every six weeks and will be compared to those receiving a different treatment or a placebo (inactive substance). Eligible participants must have a diagnosis of nail psoriasis in at least three fingernails. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for these treatments?

Research has shown that injecting methotrexate directly into the affected area is generally safe for treating nail psoriasis. In some studies, patients experienced only a few side effects from these injections. One report described four cases where lower doses proved both effective and safe. Additionally, a small initial study supports the safety of these injections, suggesting they could be a promising option for nail psoriasis.

Methotrexate is a well-known treatment for psoriasis and is already used for other conditions, which supports its safety. However, while these injections are usually well-tolerated, more research is needed to fully confirm their safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for psoriasis, which often involve topical creams or systemic drugs, this trial explores the potential of intralesional methotrexate injections directly into the nail bed. This delivery method allows for targeted treatment, potentially reducing systemic side effects common with oral methotrexate. Researchers are excited because this approach could offer a more efficient way to alleviate nail psoriasis, a notoriously hard-to-treat aspect of the condition. Additionally, the trial includes a comparison with triamcinolone acetonide injections, another established treatment, and a placebo, which could provide valuable insights into the relative effectiveness of these targeted therapies.

What evidence suggests that this trial's treatments could be effective for nail psoriasis?

Research has shown that methotrexate injections effectively treat nail psoriasis. In this trial, participants will receive intralesional methotrexate injections, which studies have demonstrated significantly reduce the Nail Psoriasis Severity Index (NAPSI) score, indicating decreased severity. One study reported a reduction in the NAPSI score from 3.70 to 0.67, showing significant improvement. Another treatment option in this trial is triamcinolone acetonide, which has also proven effective with few side effects. Overall, methotrexate injections have shown promising results in reducing nail psoriasis symptoms. ^{4 6 7 8 9}

Who Is on the Research Team?

Shari Lipner, MD,PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7007033/

Nail psoriasis treated with intralesional methotrexate ... A literature review shows that intralesional MTX has been successfully used for several indications with no complications reported.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0365059624001922?dgcid=rss_sd_all

Treatment of nail psoriasis with intralesional methotrexate Intramatrix injection of methotrexate showed the greatest benefit with minimal side effects and results comparable to TAC injection. Cyclosporine was the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11135956/

Efficacy of Intralesional Methotrexate Injection versus ... Both methotrexate and triamcinolone acetonide are effective in treating nail psoriasis based on the reduction in NAPSI score.

4. jaad.org jaad.org/article/S0190-9622(20)30787-8/fulltext

Treatment of nail psoriasis with intramatrical methotrexate After the intervention, we observed a statistically significant decrease in the Nail Psoriasis Severity Index score with minimal adverse effects ...

5. link.springer.com link.springer.com/article/10.1007/s13555-021-00523-x

Nail Psoriasis: A Review of Effective Therapies and ... Injections were given weekly for 6 weeks. The mean NAPSI score was reduced significantly from 3.70 to 0.67 at 12 weeks (p < 0.001). The average ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9303444/

A pilot study of intralesional methotrexate injections versus ... Intralesional TA injections are considered a safe and effective method for the treatment of nail psoriasis. Intralesional MTX injections have also been ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05408208

Study Details | NCT05408208 | Intralesional Injection Of ... Taking aseptic condition ,One psoriatic plaque will treated with Intralesional injection of methotrexate (25mg /ml) at dosage of 0.1 ml /cm2.

8. mayoclinic.org mayoclinic.org/drugs-supplements/methotrexate-injection-route-subcutaneous-route/description/drg-20064776

Methotrexate (injection route, subcutaneous route) For patients with arthritis or psoriasis, methotrexate may work by improving the immune system. ... However, safety and efficacy have not been established in ...

9. dovepress.com dovepress.com/the-anti-psoriatic-efficacy-and-safety-profile-of-topical-and-intrales-peer-reviewed-fulltext-article-CCID

Anti-psoriatic efficacy of topical and intralesional MTX | CCID A 25 mg/mL MTX solution injected intralesionally at the nail matrix worked well for nail psoriasis recalcitrant to topical treatment.