Local Methotrexate Injections for the Treatment of Nail Psoriasis
Phase 4
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06578728
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intralesional Placebo (saline) Saline Participants receive intralesional saline injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions. Intralesional Methotrexate Methotrexate Participants receive intralesional methotrexate injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions. Intralesional Triamcinolone Acetonide Triamcinolone Acetonide 10mg/mL Participants receive intralesional triamcinolone acetonide injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
- Primary Outcome Measures
Name Time Method Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37) 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.
...Change from baseline of nail dystrophy as measured by the Physician-Assessed Global Improvement Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37) 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.
...
- Secondary Outcome Measures
Name Time Method Treatment-Related Adverse Events 37 weeks Number of participants with either treatment-related adverse events or treatment-related side effects in each treatment arm.
Trial Locations
- Locations (1)
Israel Englander Department of Dermatology
🇺🇸New York, New York, United States