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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33879

Enrollment

Registered

2008-07-16

Start date

2009-09-15

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermatitis eczema

Interventions

Daily oral treatment with 30 mg prednisolone for 15 days. In group B and C placebo can be given instead of prednisolone for a maximum of 2 days.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The effect of prednisolone on several metabolic parameters will be measured in blood. Also will be studied whether the negative metabolic effects in AD patients are modulated in the same way as in healthy subjects. In group A and B disease activity will be assessed by a trained dermatologist.	—

Secondary

Measure	Time frame
Identification of biomarkers in blood (e.g. lymphocyte count) that reflect the immunosuppressive/ anti-inflammatory effect of daily oral treatment with 30 mg prednisolone in patients with chronic atopic dermatitis.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)