A Phase 2 Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Atopic Dermatitis
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
- 2
- 主要终点
- The primary efficacy endpoint is "Treatment Success," a static endpoint defined as a score of 0 to 1 at Day 28 (at the end of the study treatment period) by the Investigator's Global Assessment (IGA) scoring system for atopic dermatitis status.
研究概览
简要总结
PH-10 is a formulation of rose bengal disodium (RB) for topical administration to the skin. PH-10 is capable of undergoing photochemical reactions when activated by ambient light. This phase 2 study will assess whether topical PH-10 applied once daily to mild, moderate or severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of the skin when activated by ambient light.
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.
- •Mild, moderate or severe atopic dermatitis.
- •Presence of atopic dermatitis areas outside the head and face with a baseline Investigator Global Assessment (IGA) of 2 (mild disease), 3 (moderate) or 4 (severe disease) at screening.
- •Written informed consent by the subject or legal guardian.
排除标准
- •Women who are pregnant, attempting to conceive, or nursing an infant.
- •Subjects who have received phototherapy (UVB, PUVA) or systemic therapy (immunosuppressants, cytostatics, corticosteroids) within 4 weeks.
- •Subjects who have received systemic antibiotics within 2 weeks.
- •Subjects who have received topical therapy (tar, corticosteroids) within 7 days.
- •Subjects who have received investigational drugs in a clinical research study within 4 weeks.
- •Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of initiation of study treatment.
- •Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- •Subjects with clinical conditions that 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
PH-10 treatment
干预措施: PH-10 (Drug)
结局指标
主要结局
The primary efficacy endpoint is "Treatment Success," a static endpoint defined as a score of 0 to 1 at Day 28 (at the end of the study treatment period) by the Investigator's Global Assessment (IGA) scoring system for atopic dermatitis status.
时间窗: 28 days
Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
时间窗: 8 weeks
次要结局
- Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment.(8 weeks)
- Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment.(8 weeks)
- Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment.(8 weeks)
- Adverse change in clinical laboratory tests (CBC and CMP).(8 weeks)
- Adverse change in vital signs (BP, pulse, temperature).(8 weeks)