Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy after 3 weeks as compared to baseline.
研究概览
简要总结
The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on plaque Psoriasis Vulgaris.
The study will include subjects at plaque stage from 5-20% body area involvement. A total of 30 subjects will be treated with cream application on affected areas twice daily for three weeks.The efficacy of the preparation will be documented by PASI score, Global physician assessment and photos.
详细描述
Psoriasis Vulgaris remains a widespread clinical entity with chronic outflares and various regimens of treatment, none of them definitive. A new safe and efficacious, external treatment is required for.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age 18-60
- •Diagnosis of PS by a dermatologist with lesions on arms, legs or trunk
- •Subjects have stable plaque PS, mild to moderate form, Body Surface Area of 5-20%.
- •Subject understood and signed an informed consent form
排除标准
- •Guttate, erythrodermic, palm-plantar or pustular psoriasis as sole or predominant form of psoriasis.
- •Hypersensitivity to sunlight; history of Lupus, PMLE, or any disease known to be worsened by UV light exposure
- •Pregnancy, breast feeding
- •History of cancer, excluding non-melanoma skin cancer.
- •Patients with history of ischemic heart disease (e.g. angina pectoris, myocardial infarction); cerebrovascular syndromes, peripheral vascular or uncontrolled hypertension. Subjects with known severe hepatic and/or severe renal insufficiency.
- •Any medical condition that, in the opinion of the Investigator, would jeopardize the health of the patient during the course of this study.
- •Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within 4 months or 5 drug half-lives prior to checkup.
- •Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 8-week period prior to randomization. Subjects using within the 8 week period prior to randomization PUVA or Phototherapy. Use of SSRI or MAO inhibitors.
- •Subjects using one of the following TOPICAL drugs for the treatment of PS within 2 weeks prior to randomization: e.g. WHO group I-II corticosteroids, retinoids, Vit. D analogues, immunomodulators, Anthracene derivatives, Salicylic acid.
- •Subjects with current participation in any other interventional clinical or subjects with any concomitant dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
研究组 & 干预措施
DD-25
A concentration of 0.025% of topical DD-25 cream.
干预措施: DD-25 (Drug)
结局指标
主要结局
Efficacy after 3 weeks as compared to baseline.
时间窗: 3 weeks
Evaluation of the effectiveness of DD-25 over a period of 3 weeks treatment by analyzing the changes in the Psoriasis Area \& Severity Index (PASI) in moderate to mild Plaque Psoriasis patients. Improvement to be assessed by changes in erythema, induration and desquamation as seen on days 0, 10 and 21.
次要结局
- PASI reduction of 50%(3 weeks)