Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast
研究概览
简要总结
This study will evaluate the anti-pruritic effect of apremilast in patients with known PN.
详细描述
Prurigo nodularis(PN) is a chronic skin disease, characterized by severe pruritus, multiple hyperkeratotic nodules and papules often located on the extensor part of the upper and lower extremities with a symmetrical distribution. The disease often appears between 20-60 years of age affecting men and women equally.
The pathogenesis of PN is poorly understood and it is unknown whether PN is a primary dermatological disease or if it arises secondary to intense pruritus and scratching of the skin with other diseases being the cause of the itching.
A number of studies have investigated if certain biochemical parameters are involved in mediating PN e.g. studies have indicated that the small nerve fibres in dermis in lesioned skin have an increased density of Substance P (neuropeptide and a well-known mediator of pruritus. when compared to non-lesioned skin.Other studies have suggested that patients with PN have a high presence of nerve growth factor (NGF) in dermis leading to modulation of the small nerve fibres, as well as an increased number of eosinophilic granulocytes, mast- and Merkel cells. Additionally, studies have found increased levels of IL-6 and IL-31 in blood in patient with PN. However the pathogenesis of PN remains unknown.
Among patients with atopic dermatitis there is a higher frequency of patients with PN as well as PN seem to be associated with certain liver- and kidney diseases. Anxiety and depression are also more common in patients with PN.
Patients with PN suffer from impaired quality of life due to ongoing pruritus and skin lesions(5). PN is mainly treated with topical steroids, UVB, PUVA or thalidomide, although none of these treatments seem to be able to control the disease and furthermore a number of these treatments are associated with several side effects.
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
- •> 18 years of age
- •PN verified diagnosis by characteristic clinical features
- •Moderate to severe PN
- •Failure of local steroid and light treatment to control disease and symptoms.
- •Be able to speak and understand Danish.
- •Patients must have given their informed consent to the protocol and to the clinical procedures.
排除标准
- •Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0
- •Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0 or 5 pharmacokinetic half-lives, whichever is longer
- •Patients who have received any other study medication 4 weeks prior to day 0
- •Patients with other clinically significant disorders
- •Patients with active TB/serious infections
- •Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol. Patients with previous endogene depression.
- •Pregnancy
- •Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring og sterilization.
- •Occlusive cap or condom with spermicidal cream is not considered as an effective contraception. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception.
- •Patients who have received any live vaccines 6 weeks prior to day 0 or who are planning to receive a live vaccine during the study
- •Allergy to apremilast or any of the other ingredients in Otezla®
研究组 & 干预措施
apremilast
apremilast standard doses
干预措施: Apremilast Oral Product (Drug)
结局指标
主要结局
1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast
时间窗: 12 weeks
1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast
次要结局
未报告次要终点
研究者
Tanja Todberg, MD
MD, principal investigator
University of Copenhagen