Nail Psoriasis
Conditions
Keywords
methotrexate, triamcinolone acetonide
Brief summary
The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis.
Interventions
DRUGMethotrexate
25mg/mL intralesional injection into nail bed/nail matrix
10mg/mL intralesional injection into nail bed/nail matrix
DRUGSaline
saline intralesional injection into nail bed/nail matrix
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patient blinded.
Intervention model description
Intra-subject randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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. |
| 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Related Adverse Events | 37 weeks | Number of participants with either treatment-related adverse events or treatment-related side effects in each treatment arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShari Lipner, MD, PhD
Weill Medical College of Cornell University
Outcome results
None listed