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
- Conditions
- atopic dermatitiseczema1000381610014982
- Registration Number
- NL-OMON33879
- Lead Sponsor
- Schering-Plough (voorheen Organon)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The effect of prednisolone on several metabolic parameters will be measured in<br /><br>blood. Also will be studied whether the negative metabolic effects in AD<br /><br>patients are modulated in the same way as in healthy subjects. In group A and B<br /><br>disease activity will be assessed by a trained dermatologist.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Identification of biomarkers in blood (e.g. lymphocyte count) that reflect the<br /><br>immunosuppressive/ anti-inflammatory effect of daily oral treatment with 30 mg<br /><br>prednisolone in patients with chronic atopic dermatitis.</p><br>