Local Methotrexate Injections for the Treatment of Nail P... | NCT06578728

NCT06578728

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Methotrexate	Drug	25mg/mL intralesional injection into nail bed/nail matrix	Intralesional Methotrexate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Eligibility Module

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

Name	Affiliation	Role
Shari Lipner, MD, PhD	Weill Medical College of Cornell University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Israel Englander Department of Dermatology		New York	New York	10021	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25471223	Background	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.
11012585	Background

ID	Term
D008727	Methotrexate
D014222	Triamcinolone Acetonide
D012965	Sodium Chloride

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring