EUCTR2006-001062-17-SE进行中（未招募）不适用
Efficacy and safety of ASF-1096 Cream 0.5% in the treatment of patients with newly developed discoid lupus erythematosus (DLE) lesions. A multi centre clinical phase 2, placebo controlled and double blind proof of concept study. - Lupus study
Astion Danmark A/S0 个研究点目标入组 52 人开始时间: 2007年1月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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
- •All of the following criteria have to be met for inclusion of a patient in the study:
- •Patients of any gender aged from 18 to 70 years;
- •A clinical diagnosis of either DLE or SLE;
- •At least one newly developed, sharply demarcated DLE lesion (target lesion) with erythema score >1 and scaling score >1;
- •Histological results from biopsy confirming the diagnosis will be obtained at the beginning of the study, in case histological results confirming the diagnosis are available a new biopsy is not needed;
- •The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- •Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and one month after the end of the study; systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide;
- •Willing and able to comply to the study procedures;
- •Prepared to grant authorised persons access to the medical records;
- •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
- •Patients will not be included in the study when one or more of the following conditions are met:
- •Active skin disease other then DLE or another progressive or serious disease that interferes with the study outcome;
- •Scarring at the traget lesion;
- •Keratonisation of treated lesion;
- •Concomitant, or within four weeks prior to dosing, treatment with corticosteroids (local or systemic), anti-malarials, retinoids or thalidomide;
- •Systemic treatment of SLE;
- •Concomitant, or within four weeks prior to dosing, treatment with medicinal products containing salbutamol (local or systemic);
- •Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •Participation in another clinical trial, including the four week period preceding the study;
- •Known allergic reactions to components of the study preparations;
- •Pregnancy (according to pregnancy test) or nursing.
研究者
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