Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis
研究概览
简要总结
This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the 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
- Double (Participant, Outcomes Assessor)
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
- •At least 18 years of age
- •Diagnosed with nail psoriasis in at least 2 fingernails
- •Willing to give written informed consent and able to adhere to procedures and visit schedules
- •Must consent to having the fingernails photographed during the study period
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 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 for >1 month within the 6 months of study (exception: inhaled steroids)
- •Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study
- •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, anti-fungal 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
Placebo
Participants receive an intralesional injection of 0.1-0.2 mL of normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks.
干预措施: Placebos (Drug)
Triamcinolone Acetonide 2.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
干预措施: Triamcinolone Acetonide 2.5 mg/mL (Drug)
Triamcinolone Acetonide 5.0 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
干预措施: Triamcinolone Acetonide 5.0 mg/mL (Drug)
Triamcinolone Acetonide 7.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
干预措施: Triamcinolone Acetonide 7.5 mg/mL (Drug)
Triamcinolone Acetonide 10 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
干预措施: Triamcinolone Acetonide 10 mg/mL (Drug)
结局指标
主要结局
Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis
时间窗: 24 weeks (end of study)
The most effective concentration of intralesional triamcinolone acetonide will be determined between 0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10.0 mg/mL.
次要结局
- Change From Baseline in Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10)(Baseline, 24 weeks (end of study))
- Number of Participants With at Least One Adverse Event(24 weeks (end of study))
- Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)(Baseline, 24 weeks (end of study))