Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The Physician's Global Assessment ("PGA") criteria. The PGA involves a 7 point scale (clear, minimal, mild, moderate, severe and very severe) and grading conducted at 0, 2, 4, 8 and 12 weeks.
研究概览
简要总结
The purpose of this study is to test the effectiveness of DermiPsor's DPS-102 (test product) in patients with scalp Psoroasis. The study is also intended to assess the safety of the product.
详细描述
Psoriasis is a non-contagious skin disorder affecting up to 2% of the world population. It is estimated that 26 million people in the U.S. and Europe suffer from psoriasis. Forty percent (40%) of these suffer from psoriasis of the scalp. Currently, there are three primary modalities for the treatment of psoriasis: topical, phototherapy and systemic treatments. While existing treatments provide varying degrees of relief for this illness, they do not provide a long-term cure. Additionally, there is evidence that some of these existing treatments may cause significant side effect. The purpose of this study is to demonstrate that DermiPsor's DPS-102 (test product) is statistically more effective for the treatment of psoriasis current topical treatment options. It is also intended to assess the safety of DPS-102.
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
- Double (Participant, Care Provider)
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
- •Male or female of age 18 or older
- •Patient with a personal history of scalp psoriasis
- •Patient with treatable lesions
- •Patient with a TSS score equal or lower than
- •Patient with a PGA score equal or lower than
- •Patient with a negative urine pregnancy test at inclusion for women of childbearing potential and using an efficient contraceptive (oral contraceptives, IUD, or tubal ligation)
- •Patient agreeing to participate to the study and to sign a written informed consent and comply with study requirements.
排除标准
- •Patient treated with topical scalp treatment for scalp psoriasis within two weeks prior to the inclusion in the study (corticoids, retinoids, vitamin D derivatives),
- •Patient treated with systemic treatment for psoriasis (biologics, methotrexate, cyclosporine, retinoids) within one month prior to the inclusion in the study
- •Patient taking systemic niacin or multivitamins within past two weeks
- •Patient who start or modify a treatment with beta-blockers within one month prior to the inclusion in the study
- •Patient with PEG (Poly Ethylene Glycol) allergy
- •Pregnant or breast feeding female or female who do not use contraception,
- •Patient with an history of hypersensitivity to Dovonex/Daivonex
- •Patient who has participated in a clinical trial within three month prior inclusion,
- •Patients on Carbamazepine and Primidione (the clearance of Primidione and Carbamazepine may be reduced with the concomitant use of Nicotinamide)
- •Patient who is under guardianship, or unable to understand the information (for linguistic or mental reason), or unwilling to give her/his informed consent to participate in the study
研究组 & 干预措施
1
DPS-102
干预措施: DPS-102 (Drug)
2
Vehicle
干预措施: Vehicle / Placebo (Other)
3
Calcipotriol Monotherapy
干预措施: Calcipotriol Monotherapy (Drug)
4
Nicotinamide Monotherapy
干预措施: Nicotinamide Monotherapy (Drug)
结局指标
主要结局
The Physician's Global Assessment ("PGA") criteria. The PGA involves a 7 point scale (clear, minimal, mild, moderate, severe and very severe) and grading conducted at 0, 2, 4, 8 and 12 weeks.
时间窗: 12 weeks
The number of participants at each PGA scale level assessed at 0,2,4,8,and 12 weeks and a comparison of each individual's scale assessments over the 12 week period to assess any changes.
次要结局
- Review of haematology and blood chemistry test results, and any adverse event reports received.(12 weeks)