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.

Astion Danmark A/S0 个研究点开始时间: 2006年8月15日最近更新: 2017年8月21日

试验速览

暂无简介。

•All of the following criteria have to be met for inclusion of a patient in the study:
•Male or female patients 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 (biopsy can be taken at screening)
•No clinically relevant abnormalities at physical examination
•Is willing and able to comply to the study procedures
•Is prepared to grant authorised persons access to the medical records
•Has 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

•Patients will not be included in the study when one or more of the following conditions are met:
•Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome
•Has scarring at the target lesion
•Has keratonisation of the target 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)
•Has 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
•Has known allergic reactions to components of the study preparations
•Is pregnant (according to pregnancy test) or nursing
•Females of childbearing potential who do not fulfil one of the following criteria:
•osurgically sterile (hysterectomy or tubal ligation)
•o 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

发起方

Astion Danmark A/S