Local Methotrexate Injections for the Treatment of Nail Psoriasis
NCT ID: NCT06578728
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE4
10 participants
INTERVENTIONAL
2025-09-10
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intralesional Methotrexate
Participants receive intralesional methotrexate injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Methotrexate
25mg/mL intralesional injection into nail bed/nail matrix
Intralesional Triamcinolone Acetonide
Participants receive intralesional triamcinolone acetonide injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Triamcinolone Acetonide 10mg/mL
10mg/mL intralesional injection into nail bed/nail matrix
Intralesional Placebo (saline)
Participants receive intralesional saline injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Saline
saline intralesional injection into nail bed/nail matrix
Interventions
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Methotrexate
25mg/mL intralesional injection into nail bed/nail matrix
Triamcinolone Acetonide 10mg/mL
10mg/mL intralesional injection into nail bed/nail matrix
Saline
saline intralesional injection into nail bed/nail matrix
Eligibility Criteria
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Inclusion Criteria
* Subject must have nail psoriasis that is clinically diagnosed in at least 3 fingernails
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Shari Lipner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Israel Englander Department of Dermatology
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Deffer TA, Goette DK. Distal phalangeal atrophy secondary to topical steroid therapy. Arch Dermatol. 1987 May;123(5):571-2. No abstract available.
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.
Other Identifiers
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23-09026516
Identifier Type: -
Identifier Source: org_study_id
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