Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:06 PM
Study NCT ID:
NCT06578728
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-25
First Post:
2024-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Methotrexate Injections for the Treatment of Nail Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patient blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intra-subject randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': '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.\n\nA 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.'}, {'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)', 'description': '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.\n\nA 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.'}], 'secondaryOutcomes': [{'measure': 'Treatment-Related Adverse Events', 'timeFrame': '37 weeks', 'description': 'Number of participants with either treatment-related adverse events or treatment-related side effects in each treatment arm.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['methotrexate', 'triamcinolone acetonide'], 'conditions': ['Nail Psoriasis']}, 'referencesModule': {'references': [{'pmid': '25471223', 'type': 'BACKGROUND', '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.'}, {'pmid': '11012585', 'type': 'BACKGROUND', '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.'}, {'pmid': '25443636', 'type': 'BACKGROUND', '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.'}, {'pmid': '19911853', 'type': 'BACKGROUND', 'citation': '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': '8993953', 'type': 'BACKGROUND', 'citation': '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': '25362716', 'type': 'BACKGROUND', '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.'}, {'pmid': '29565192', 'type': 'BACKGROUND', '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.'}, {'pmid': '30731172', 'type': 'BACKGROUND', '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.'}, {'pmid': '28397295', 'type': 'BACKGROUND', '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.'}, {'pmid': '17572277', 'type': 'BACKGROUND', '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.'}, {'pmid': '2229508', 'type': 'BACKGROUND', '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."}, {'pmid': '2383026', 'type': 'BACKGROUND', '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.'}, {'pmid': '3579338', 'type': 'BACKGROUND', 'citation': 'Deffer TA, Goette DK. Distal phalangeal atrophy secondary to topical steroid therapy. Arch Dermatol. 1987 May;123(5):571-2. No abstract available.'}, {'pmid': '9892909', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be at least 18 years of age\n* Subject must have nail psoriasis that is clinically diagnosed in at least 3 fingernails\n\nExclusion Criteria:\n\n* 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\n* 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);\n* Subjects who use substances (medications, supplements, ect) known to significantly interact with drugs used as intervention in the study\n* Subject who is pregnant, breastfeeding, or planning to get pregnant\n* Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study\n* Subject who is on systemic treatment for psoriasis\n* Subject with baseline abnormalities in liver function tests or complete blood count\n* Subjects with diagnosis of renal insufficiency or impairment\n* 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)\n* 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)\n* Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff'}, 'identificationModule': {'nctId': 'NCT06578728', 'briefTitle': 'Local Methotrexate Injections for the Treatment of Nail Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Intralesional Methotrexate Injections for the Treatment of Nail Psoriasis: an Intra-subject Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '23-09026516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intralesional Methotrexate', 'description': 'Participants receive intralesional methotrexate injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intralesional Triamcinolone Acetonide', 'description': 'Participants receive intralesional triamcinolone acetonide injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.', 'interventionNames': ['Drug: Triamcinolone Acetonide 10mg/mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intralesional Placebo (saline)', 'description': 'Participants receive intralesional saline injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': '25mg/mL intralesional injection into nail bed/nail matrix', 'armGroupLabels': ['Intralesional Methotrexate']}, {'name': 'Triamcinolone Acetonide 10mg/mL', 'type': 'DRUG', 'description': '10mg/mL intralesional injection into nail bed/nail matrix', 'armGroupLabels': ['Intralesional Triamcinolone Acetonide']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'saline intralesional injection into nail bed/nail matrix', 'armGroupLabels': ['Intralesional Placebo (saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Israel Englander Department of Dermatology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Shari Lipner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}