Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of Mild-to-Moderate Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Soligenix
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale
研究概览
简要总结
To evaluate SGX302 (topical hypericin ointment and gel) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6-months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment and opaque coverage after application.
- •Have a static Investigator Global Assessment (IGA)/Psoriasis Area and Severity Index (PASI) of disease severity of mild or moderate on the body (trunk and/or limbs).
- •Have lesions involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.
排除标准
- •Use of topical anti psoriatic therapy within one week prior to the beginning of the study and willing to not use other psoriasis treatments for 4 weeks following completion of the treatment portion of the study.
- •Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study.
- •Received systemic psoriasis therapy within 4 weeks prior to the beginning of the study.
- •Received phototherapy (including laser) or photodynamic (light activated drug) therapy within 4 weeks prior to the beginning of the study.
研究组 & 干预措施
Cohort 1 - SGX302 Ointment (0.25 % Hypericin)
SGX302 (0.25 % hypericin) ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2 with a gradual escalation of light therapy up to 25 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.
干预措施: Hypericin (Drug)
Cohort 2 - SGX302 Ointment (0.25 % Hypericin)
SGX302 (0.25 % hypericin) ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2 with a faster escalation of light therapy up to 25 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.
干预措施: Hypericin (Drug)
Cohort 3 - SGX302 Gel (0.25 % Hypericin)
SGX302 (0.25 % hypericin) gel will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2 with a faster escalation of light therapy up to 40 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.
干预措施: Hypericin (Drug)
结局指标
主要结局
Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale
时间窗: 18 weeks
The percentage of patients in each treatment group that achieve a 0 or 1 score (Clear or Almost Clear) evaluation using the 5-point Investigator's Global Assessment (IGA) scale. The 5-point IGA scale: * Score 0: Clear - No signs of psoriasis; post-inflammatory hyperpigmentation may be present * Score 1: Almost Clear - No thickening; normal to pink coloration; no to minimal focal scaling * Score 2: Mild - Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling * Score 3: Moderate - Clear distinguishable to moderate thickening; dull to bright red; moderate scaling * Score 4: Severe - Severe thickening with hard edges; bright to deep red coloration; severe/coarse scaling covering almost all lesions
次要结局
- Number of patients achieving a ≥75% improvement in Psoriasis Area and Severity Index(18 weeks)
- Number of patients achieving a ≥90% improvement in Psoriasis Area and Severity Index(18 weeks)
- Number of patients achieving a 100% improvement in Psoriasis Area and Severity Index(18 weeks)