A Phase 2 Dose-Randomized, Vehicle-Controlled Study of PH-10-Aqueous Hydrogel for the Treatment of Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
研究概览
简要总结
PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque 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 (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
- •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).
- •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 psoralen plus ultraviolet A (PUVA) therapy or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
- •Subjects who have received ultraviolet B (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 agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives 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 by being involved in the study or detrimentally affect regular follow-up of the subject.
研究组 & 干预措施
PH-10 Treatment (High Dose Cohort)
干预措施: PH-10 (0.01% Rose Bengal) (Drug)
PH-10 Treatment (Mid Dose Cohort)
干预措施: PH-10 (0.005% Rose Bengal) (Drug)
PH-10 Treatment (Low Dose Cohort)
干预措施: PH-10 (0.002% Rose Bengal) (Drug)
Vehicle Control
干预措施: Vehicle (Drug)
结局指标
主要结局
The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
时间窗: 28 days
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
时间窗: 8 weeks
次要结局
- Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.(8 weeks)
- Plaque Response score changes at each visit from Day 1 pre-treatment.(8 weeks)
- Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.(8 weeks)