Local Methotrexate Injections for the Treatment of Nail Psoriasis

March 20, 2026 updated by: Weill Medical College of Cornell University

Intralesional Methotrexate Injections for the Treatment of Nail Psoriasis: an Intra-subject Randomized Controlled Trial

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Israel Englander Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject must be at least 18 years of age
  • Subject must have nail psoriasis that is clinically diagnosed in at least 3 fingernails

Exclusion Criteria:

  • Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study. This is including, but not limited to: immunodeficiency, onychomycosis, any other nail condition other than psoriasis, allergy to methotrexate, triamcinolone acetonide, local anesthetic, normal saline, or any other material used for procedures
  • Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids or IV methotrexate for >1 month within the 6 months of study (exception inhaled steroids);
  • Subjects who use substances (medications, supplements, ect) known to significantly interact with drugs used as intervention in the study
  • Subject who is pregnant, breastfeeding, or planning to get pregnant
  • Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study
  • Subject who is on systemic treatment for psoriasis
  • Subject with baseline abnormalities in liver function tests or complete blood count
  • Subjects with diagnosis of renal insufficiency or impairment
  • Subject who is unwilling to abstain from any cosmetic nail treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa nail treatments, no nail polish use, no other topical prescription nail medication)
  • Subject who is unwilling to abstain from any medical nail treatments on their nails other than the study intervention (i.e. topical steroids, antifungal creams) for the duration of the study intervention and for duration of the washout period (if applicable)
  • Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intralesional Methotrexate
Participants receive intralesional methotrexate injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Drug: Methotrexate
25mg/mL intralesional injection into nail bed/nail matrix
Active Comparator: Intralesional Triamcinolone Acetonide
Participants receive intralesional triamcinolone acetonide injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Drug: Triamcinolone Acetonide 10mg/mL
10mg/mL intralesional injection into nail bed/nail matrix
Placebo Comparator: Intralesional Placebo (saline)
Participants receive intralesional saline injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Drug: Saline
saline intralesional injection into nail bed/nail matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index
Time Frame: Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)

Mean change from baseline of the Nail Psoriasis Severity Index, which evaluates nail psoriasis symptoms with a score of 0-8 for each nail. Scores will be collected and analyzed per nail. For each nail measured by the study, patients can have a score between 0 and 8.

A score of 0 indicates no symptoms of nail psoriasis in the nail, and a score of 8 indicates nail psoriasis features are present in four quadrants of both the nail bed and nail matrix.
Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)
Change from baseline of nail dystrophy as measured by the Physician-Assessed Global Improvement
Time Frame: Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)

Mean change from baseline in physician-assessed global improvement severity rating which rates each nail on a 5-point scale (rating 0 - 4) based on the presence of nail plate pitting, crumbling, onycholysis, oil-drop discoloration, or nail bed hyperkeratosis.

A score of 0 indicates none of the listed symptoms, while a score of 4 indicates severe symptoms. Scores will be collected and analyzed per nail.
Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-Related Adverse Events
Time Frame: 37 weeks
Number of participants with either treatment-related adverse events or treatment-related side effects in each treatment arm.
37 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Shari Lipner, MD, PhD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-09026516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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