A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.
研究概览
简要总结
This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control.
Subjects with at least three distinct, stable study plaque areas will receive the experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission is observed in a treatment plaque area then treatment of that area will be discontinued and the area assessed weekly. A third plaque area (control plaque area) will receive no drug or light treatment and serve as an internal control.
Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be followed for a total of 16 weeks to allow assessment of Durability of Response of treated lesions and comprehensive follow-up of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Stable, moderate to severe plaque psoriasis in at least three distinct plaque areas, each separated by at least a 2.5-cm band of normal skin. Study plaque areas, each covering a contiguous area up to 15 x 35 cm in size, should have a minimum plaque size of 2 cm
- •All study plaque areas must be on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous sites).
- •Fitzpatrick skin type I-VI.
- •Ability to understand and sign the informed consent document.
排除标准
- •Female subjects of childbearing potential who are pregnant, attempting to conceive, or nursing an infant.
- •Subjects who have received PUVA or UVB light therapy or systemic antipsoriatic therapy within 4 weeks of study treatment (two weeks for methotrexate).
- •Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin, or Vitamin D analogs) to the study plaque areas within 2 weeks of study treatment.
- •Subjects who have received any photosensitizing or phototoxic drug within 4 weeks of study treatment.
- •Subjects who have received any approved biologic drug therapy for psoriasis within 3 months or 5 half-lives of study treatment.
- •Subjects who have participated in a clinical research study within 4 weeks of study treatment.
- •Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- •Subjects with clinical conditions that, in the opinion of the Principal Investigator, may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
研究组 & 干预措施
1
Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area.
干预措施: PH-10 (rose bengal disodium 0.001%) (Drug)
1
Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area.
干预措施: Control (Drug)
结局指标
主要结局
Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.
时间窗: 12 weeks
Treatment Success was assessed after 12 weeks and defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.
次要结局
- Time to Remission (TTR) based on the (a) number of treatments and (b) days elapsed until Treatment Success is noted in each treatment plaque area.(12 weeks)
- Adverse Experience.(16 weeks)
- Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4.(12 weeks)
- Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response.(16 weeks)