Local Methotrexate Injections for the Treatment of Nail Psoriasis

NCT06578728 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 23-09026516
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nail Psoriasis

Keywords

methotrexate; triamcinolone acetonide

Outcome Measures

Primary Outcomes (2)

• Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index

  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

  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 Outcomes (1)

• Treatment-Related Adverse Events

  37 weeks

Study Arms (3)

Intralesional Methotrexate

EXPERIMENTAL

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

Drug: Methotrexate

Intralesional Triamcinolone Acetonide

ACTIVE COMPARATOR

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

Drug: Triamcinolone Acetonide 10mg/mL

Intralesional Placebo (saline)

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Methotrexate DRUG

25mg/mL intralesional injection into nail bed/nail matrix

Intralesional Methotrexate

Triamcinolone Acetonide 10mg/mL DRUG

10mg/mL intralesional injection into nail bed/nail matrix

Intralesional Triamcinolone Acetonide

Saline DRUG

saline intralesional injection into nail bed/nail matrix

Intralesional Placebo (saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Israel Englander Department of Dermatology

New York, New York, 10021, United States

Location

Related Publications (14)

• Crowley JJ, Weinberg JM, Wu JJ, Robertson AD, Van Voorhees AS; National Psoriasis Foundation. Treatment of nail psoriasis: best practice recommendations from the Medical Board of the National Psoriasis Foundation. JAMA Dermatol. 2015 Jan;151(1):87-94. doi: 10.1001/jamadermatol.2014.2983.

  PMID: 25471223 BACKGROUND

• de Berker D. Management of nail psoriasis. Clin Exp Dermatol. 2000 Jul;25(5):357-62. doi: 10.1046/j.1365-2230.2000.00663.x.

  PMID: 11012585 BACKGROUND

• Baran R. [How to diagnose and treat psoriasis of the nails]. Presse Med. 2014 Nov;43(11):1251-9. doi: 10.1016/j.lpm.2014.06.011. Epub 2014 Oct 16. French.

  PMID: 25443636 BACKGROUND

• Edwards F, de Berker D. Nail psoriasis: clinical presentation and best practice recommendations. Drugs. 2009;69(17):2351-61. doi: 10.2165/11318180-000000000-00000.

  PMID: 19911853 BACKGROUND

• de Jong EM, Seegers BA, Gulinck MK, Boezeman JB, van de Kerkhof PC. Psoriasis of the nails associated with disability in a large number of patients: results of a recent interview with 1,728 patients. Dermatology. 1996;193(4):300-3. doi: 10.1159/000246274.

  PMID: 8993953 BACKGROUND

• Armstrong AW, Tuong W, Love TJ, Carneiro S, Grynszpan R, Lee SS, Kavanaugh A. Treatments for nail psoriasis: a systematic review by the GRAPPA Nail Psoriasis Work Group. J Rheumatol. 2014 Nov;41(11):2306-14. doi: 10.3899/jrheum.140881.

  PMID: 25362716 BACKGROUND

• Kivelevitch D, Frieder J, Watson I, Paek SY, Menter MA. Pharmacotherapeutic approaches for treating psoriasis in difficult-to-treat areas. Expert Opin Pharmacother. 2018 Apr;19(6):561-575. doi: 10.1080/14656566.2018.1448788. Epub 2018 Mar 22.

  PMID: 29565192 BACKGROUND

• Rigopoulos D, Baran R, Chiheb S, Daniel CR 3rd, Di Chiacchio N, Gregoriou S, Grover C, Haneke E, Iorizzo M, Pasch M, Piraccini BM, Rich P, Richert B, Rompoti N, Rubin AI, Singal A, Starace M, Tosti A, Triantafyllopoulou I, Zaiac M. Recommendations for the definition, evaluation, and treatment of nail psoriasis in adult patients with no or mild skin psoriasis: A dermatologist and nail expert group consensus. J Am Acad Dermatol. 2019 Jul;81(1):228-240. doi: 10.1016/j.jaad.2019.01.072. Epub 2019 Feb 5.

  PMID: 30731172 BACKGROUND

• Grover C, Daulatabad D, Singal A. Role of nail bed methotrexate injections in isolated nail psoriasis: conventional drug via an unconventional route. Clin Exp Dermatol. 2017 Jun;42(4):420-423. doi: 10.1111/ced.13087. Epub 2017 Apr 10.

  PMID: 28397295 BACKGROUND

• Jiaravuthisan MM, Sasseville D, Vender RB, Murphy F, Muhn CY. Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy. J Am Acad Dermatol. 2007 Jul;57(1):1-27. doi: 10.1016/j.jaad.2005.07.073.

  PMID: 17572277 BACKGROUND

• Wolf R, Tur E, Brenner S. Corticosteroid-induced 'disappearing digit'. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):755-6. doi: 10.1016/s0190-9622(08)81079-1. No abstract available.

  PMID: 2229508 BACKGROUND

• Requena L, Zamora E, Martin L. Acroatrophy secondary to long-standing applications of topical steroids. Arch Dermatol. 1990 Aug;126(8):1013-4. No abstract available.

  PMID: 2383026 BACKGROUND

• Deffer TA, Goette DK. Distal phalangeal atrophy secondary to topical steroid therapy. Arch Dermatol. 1987 May;123(5):571-2. No abstract available.

  PMID: 3579338 BACKGROUND

• Tosti A, Piraccini BM, Cameli N, Kokely F, Plozzer C, Cannata GE, Benelli C. Calcipotriol ointment in nail psoriasis: a controlled double-blind comparison with betamethasone dipropionate and salicylic acid. Br J Dermatol. 1998 Oct;139(4):655-9. doi: 10.1046/j.1365-2133.1998.02462.x.

  PMID: 9892909 BACKGROUND

MeSH Terms

Interventions

Methotrexate; Triamcinolone Acetonide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Shari Lipner, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intra-subject randomized controlled trial

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)