Intralesional Methotrexate Injections for the Treatment of Nail Psoriasis: an Intra-subject Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index
研究概览
简要总结
The investigators hope to learn the efficacy of methotrexate injections for treatment of nail psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patient blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years of age
- •Subject must have nail psoriasis that is clinically diagnosed in at least 3 fingernails
排除标准
- •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
研究组 & 干预措施
Intralesional Triamcinolone Acetonide
Participants receive intralesional triamcinolone acetonide injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
干预措施: Triamcinolone Acetonide 10mg/mL (Drug)
Intralesional Placebo (saline)
Participants receive intralesional saline injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
干预措施: Saline (Drug)
Intralesional Methotrexate
Participants receive intralesional methotrexate injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index
时间窗: 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
时间窗: 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.
次要结局
- Treatment-Related Adverse Events(37 weeks)