A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from baseline in EGFR density in epidermis of psoriasis lesion
研究概览
简要总结
Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Mild to moderate psoriasis (all types) with active plaques on both body sides accessible for biopsy and self product application
- •EGFR immunohistochemistry score > 5
- •Age 18-60 years
排除标准
- •Systemic psoriasis treatment 3 months prior and during the study
- •Local psoriasis treatment on the investigational sites in the last 30 days or during the study
- •Known hypersensitivity or allergy to the EGF containing product (Newskin) and/or to Vaseline/10% salicylic acid and/or to local anaesthetics of the amid type
- •Known or suspected non-compliance to study protocol Coagulopathy or treatment with anticoagulants
- •History of malignant disease Other clinically relevant concomitant disease state Participation in another investigational drug study in the last 30 days
研究组 & 干预措施
EGF Cream
干预措施: Human recombinant epidermal growth factor (Drug)
Placebo cream
干预措施: Placebo cream (Other)
结局指标
主要结局
Change from baseline in EGFR density in epidermis of psoriasis lesion
时间窗: Day 66
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment, which is on day 66. EGFR immunohistochemistry will be performed with a murine antibody directed against the extracellular domain of human EGFR. A pathologist blinded to the patient's characteristics and treatment modalities assesses the immunohistochemistry staining in three epidermal layers. A score ranging form 0 (no staining) to 3 (intense staining) is applied, resulting in a total score ranging form 0 (3x0) to 9 (3x3).
次要结局
- Change to baseline in target lesion severity score (PASI)(Day 80)
- Change to baseline in histological feature: thickness of the epidermis(Day 66)
- Number of participants with adverse events(Day 80)
- Change to baseline in the histological feature: acanthosis(Day 66)
- Change to baseline in histological feature: epidermal/dermal lymphocytic infiltrates(Day 66)