A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10 Aqueous Hydrogel to Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application
研究概览
简要总结
This is a multicenter study of subjects with mild to moderate psoriasis. Subjects will apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites). Biopsies of one target plaque will be collected at baseline (at least 7 days prior to first study treatment on Day 1) and at Days 29 and 64, with a 7-day interval between biopsy at Day 29 and commencement of application of application of active PH-10 on Day 36. Study data from each subject will serve as an internal control (i.e., assessment at baseline and at the end of application of PH-10 vehicle) for assessment of clinical and cellular response to active investigational agent.
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
- •Men or women, age 18 or older.
- •Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
- •At least one target plaque having a minimum diameter of 5 cm (2 inches) with uniform mild to moderate plaque psoriasis.
- •Fitzpatrick skin type I-VI.
- •Written informed consent by the subject or legal guardian.
排除标准
- •Female subjects of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
- •Subjects who have received PH-
- •Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (14 days for methotrexate).
- •Subjects who have received UVB light therapy within 14 days of study initiation.
- •Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
- •Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
- •Subjects who have participated in a clinical research study within 28 days of study initiation.
- •Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- •Subjects with clinical conditions that, in the opinion of the Investigator, may pose a health risk to the subject because of involvement in the study or detrimentally affect regular follow-up of the subject.
研究组 & 干预措施
PH-10
Active treatment
干预措施: Topical Rose Bengal, 0.005% (Drug)
结局指标
主要结局
Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application
时间窗: 28 days
次要结局
- Incidence of adverse changes in weight or vital signs(28 days)
- Incidence of adverse changes in clinical laboratory tests(28 days)
- Incidence of adverse experiences(28 days)
- Plaque Response changes from Day 1 pre-treatment(28 days)
- Psoriasis Severity Index (PSI) changes from pre-treatment(28 days)
- Pruritus Self-Assessment score changes from Day 1 pre-treatment(28 days)
- Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque(28 days)
- Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin(28 days)