The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1
25mg/mL intralesional injection into nail bed/nail matrix
10mg/mL intralesional injection into nail bed/nail matrix
saline intralesional injection into nail bed/nail matrix
Israel Englander Department of Dermatology
New York, New York, United States
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.
Time frame: 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.
Time frame: Baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)
Treatment-Related Adverse Events
Number of participants with either treatment-related adverse events or treatment-related side effects in each treatment arm.
Time frame: 37 weeks
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