The effects of topical corticosteroid use on insulin sensitivity and bone turnover

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2018-004370-96-DK
• Lead Sponsor: Jacob Pontoppidan Thyssen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-17
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Inclusion criteria
•Age 18–75 years
•AD according to the Hanifin and Rajka Criteria22
•AD for at least 3 years
•BMI = 30 kg/m2
•Haemoglobin A1c (HbA1c) = 42 mmol/mol (6.0%)
•Normal haemoglobin
•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 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
•Diagnosed diabetes mellitus
•Other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside AD and non-treatment demanding rhinitis or asthma (treated within the last 4 weeks)
•Pregnancy or breast feeding
•Treatment with drugs that might affect the glucose metabolism beside TCS within a month prior to the project
•Daily smoker, alcoholic, or drug abuser

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified