EUCTR2005-005638-10-DE进行中（未招募）不适用
Evaluation of the antipruritic effect of Elidel (pimecrolimus) in non-atopic pruritic disease
niversity of Münster0 个研究点开始时间: 2006年9月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age: 18 - 70 years
- •Diagnosis: Prurigo nodularis
- •Pruritus intensity above VAS 3 (Visual analoge scale 0 to 10)
- •Nodules on arms and legs (target areas: arms)
- •No effective current external or internal antipruritic medication
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •prurigo nodularis with massive excoriations and/or local infections
- •atopic dermatitis, predisposition for atopic dermatitis
- •Itch intensity below VAS 4 (visual analoge scale 0 to 10)
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
- •Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. ‘Medically approved’ contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
- •psychosomatic and psychiatric diseases
- •History of active malignancy of any organ system
- •actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)
- •Systemic immunosuppression
- •Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry
- •current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake- inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.
- •wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)
- •History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream
- •Participation in other clinical studies within the last 4 weeks
研究者
相似试验
已完成
2 期
Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic DiseasePrurigo NodularisNCT00507832University Hospital Muenster30
撤回
不适用
Cutaneous Lupus Erythematosus and ElidelLupus Erythematosus, CutaneousLupus Erythematosus, DiscoidNCT00222183University of Leipzig
已完成
2 期
Antipruritic effect of Pimecrolimus Cream %1 in Patients with Chronic Renal FailureEnd stage renal disease.?????? ????? ????? ???????N 18.0IRCT201011015069N1Gachsaran Islamic Azad University60
招募中
3 期
The effectiveness of anti-itch emollients in psoriatic patients: a randomized double - blinded controlled trial study1. Itch reduction effect2. Improvement of psoriatic lesionsItchPsoriasisEmollientTCTR20200626003Division of Dermatology, Department of medicine, Faculty of Medicine, Ramathibodi hospital40
已完成
2 期
PRISM Study-Pruritus Relief Through Itch Scratch ModulationPrurigo NodularisNCT03497975Trevi Therapeutics353