CTRI/2025/07/090140尚未招募不适用
Pharmacokinetic and pharmacodynamic evaluation of topical liposomal formulation of cyclosporine in patients with chronic plaque psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in PASI score from baseline to 12 weeks
研究概览
简要总结
This study is an open label randomized parallel group trial for Evaluation of safety and efficacy of topical formulation of cyclosporine in patients with chronic plaque psoriasis that will be conducted in the Department of Dermatology and Pharmacology, PGIMER, Chandigarh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged 18 years or older
- •Fulfilling the criteria of stable plaque psoriasis with bilaterally symmetrical plaques measuring less than equal to 100 cm sq of the body surface area with the PASI score less than equal to
- •Both male and female patients willing to use appropriate method of contraception as per investigator’s discretion throughout the study.
- •Willing to provide informed consent.
排除标准
- •Impaired kidney function
- •Uncontrolled hypertension
- •Past or present malignancy
- •Current infection
- •Female patient who is breastfeeding, pregnant, or who is planning a pregnancy during the study.
- •Patient has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis
- •Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
- •Concomitant immunosuppressive therapy.
- •Primary or secondary immunodeficiency
- •Known hypersensitivity to drug or its ingredients.
- •Subject has had a major surgery within 8 weeks prior to baseline (Day 0) or has a surgery planned during the study.
- •Subject has any clinically significant medical condition or physical/laboratory abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
- •Receiving drugs which have known pharmacological interactions with cyclosporine
- •Known alcohol or drug abuse in the last 6 months.
结局指标
主要结局
Change in PASI score from baseline to 12 weeks
时间窗: 12 weeks
次要结局
- Change in Physician Global Assessment(12 weeks)
- Mean percentage change in PASI score
- Proportion of patients achieving PASI 75(12 weeks)
- Change in the Dermatology Life Quality Index(12 weeks)
- Safety Assessments(12 weeks)
研究者
Aarzoo
Post Graduate Institute of Medical Education and Research
研究点 (1)
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