Clinical trial NCT06578728: Local Methotrexate Injections for the Treatment of Nail Psoriasis
Official title: Intralesional Methotrexate Injections for the Treatment of Nail Psoriasis: an Intra-subject Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Nail Psoriasis
Keywords: methotrexate
triamcinolone acetonide
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-subject randomized controlled trial
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index
timeFrame: Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)
measure: Change from baseline of nail dystrophy as measured by the Physician-Assessed Global Improvement
timeFrame: Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)
Secondary outcomes:
measure: Treatment-Related Adverse Events
timeFrame: 37 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Israel Englander Department of Dermatology
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Shari Lipner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Deffer TA, Goette DK. Distal phalangeal atrophy secondary to topical steroid therapy. Arch Dermatol. 1987 May;123(5):571-2. No abstract available.
citation: 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.