Diacerein for the treatment of atopic dermatitis - Diacerein for AD

niversity Hospital of Dermatology, Paracelsus Medical University0 个研究点开始时间: 2015年1月13日最近更新: 2016年3月14日

适应症

试验速览

暂无简介。

•- Minimum age of 18 years
•- Atopic dermatitis, mild to medium degree of severity (SCORAD < 50 points), with according diagnostic criteria after Hanifin and Rajka
•- Presence of lesional skin changes of mild to medium grade, characterized by the modified, local SCORAD (scoring atopic dermatitis) of at least 4 and confirmed by a qualified investigator.
•- Presence of mild to medium degree lesions on at least 3% of the body surface, suitable for topical therapy
•- signature patient 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 9
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•- Simultaneous participation in another clinical study
•- Known or suspected intolerances against diacerein, auxiliaries of the investigational product (especially tartrazine) or substances with similar structure.
•- Known or suspected intolerances against the cream base.
•- Pregnancy or lactation
•- Use of topic, anti-pruritic therapy of antibiotic therapy at the treated body areas, 7 days before the beginning of the trial.
•- Systemic therapy with known sedative or anti-pruretic effect 2 weeks before the beginning of the trial.
•- Topical application of Tacrolimus cream 0,03% or pimecrolimus cream 1% two weeks before the beginning of the trial on the treated body areas.
•- Phototherapy or systemic therapy with known effect on atopic dermatitis one month before the beginning of the trial.
•- Clinically super infected atopic dermatitis at the treated skin area.
•- Further skin diseases, apart from atopic dermatitis, at the treated skin areas like for example tinea corporis, intertriginous tinea, scabies, impetigo or chickenpox.
•- Other relevant diseases (acute infections,active tumors, ...)
•- Patients with severe hepatic impairment
•- immunosuppresed patients

发起方

niversity Hospital of Dermatology, Paracelsus Medical University