A partly blinded single center trial studying the effect of daily oral treatment with 30 mg prednisolone during two weeks on metabolic and disease activity parameters in patients with severe chronic atopic dermatitis and in healthy volunteers - Prednisolone in atopic dermatitis an exploratory biomarker trial

Schering-Plough (voorheen Organon)0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•For Patients with atopic dermatitis:
•1. Atopic dermatitis according to the criteria of Hanifin and Rajka (1980).
•2. Having severe chronic atopic dermatitis according to the treating dermatologist, in need of oral immunosuppressant treatment.;For all subjects:
•3. Male or female at the age of 18-65 years (extremes included) on the day of the first dosing. Females of child bearing potential willing to use a double barrier method of birth control (e.g. hormonal contraception or IUD in combination with a condom or a diaphragm with spermicide) unless the subject has a vasectomized partner (> 6 months) or the subject is abstinent, during the trial.
•4. Have a body weight resulting in a body mass index (BMI) of 20-32 kg/m2 (extremes included).

•For Patients with atopic dermatitis:
•1. Having bacterial or viral infected eczema. ;For all subjects:
•2. History of familiar Diabetes type II (first line).
•3. Clinically relevant history or presence of any medical disorder, potentially interfering with the trial e.g., diabetes, presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease and/or conditions needing special attention as mentioned in the Summary of Product Characteristics (SmPC) of prednisolone.
•4. History of malignancy within the last five years.
•5. Clinically relevant vital signs or physical findings at screening as judged by the investigator.
•6. Fasting glucose level of >= 5.6 mmol/l.

发起方

Schering-Plough (voorheen Organon)