Atopic dermatitis MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Betnovate (Betamethasone) 0.1% ointment
Pharmaceutical Form:
INN or Proposed INN: Betnovate
CAS Number: 378-44-9
Other descriptive name: BETAMETHASONE
Concentration unit: % (W/W) percent
Sponsors
Jacob Pontoppidan Thyssen
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We hypothesise that use of TCS elicits insulin resistance and increases bone resorption (indicating increased risk of osteoporosis) in AD patients. The aim is, therefore, to explore the adverse systemic drug reactions of TCS. Specifically, we aim to 1. evaluate whether full-body TCS treatment results in hepatic and/or whole-body insulin resistance (the forerunner of T2D) as well as increased bone resorption (indicating increased risk of osteoporosis) in patients with AD 2. evaluate the effect of TCS on skin and serum biomarkers of skin barrier function as well as skin microbiome composition;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is change in whole-body insulin sensitivity during treatment with TCS compared to the control group treated with TCI. Insulin sensitivity will be assessed by the hyperinsulinaemic euglycaemic clamp method with glucose tracer and indirect calorimetry (rate of disappearance (Rd)).;Timepoint(s) of evaluation of this end point: After all patients have completed the study and samples are analysed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints are markers of bone resorption and formation including C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type 1 procollagen (P1NP) and parathyroid hormone (PTH), respectively, and body composition (assessed by dual-energy X-ray absorptiometry (DXA) scan). Other secondary endpoints include differences between patients treated with TCS and TCI controls during basal and insulin-stimulated steady-state in: • Glucose oxidation (assessed by indirect calorimetry) • Non-oxidative glucose metabolism (NOGM) • Endogenous glucose production (calculated from glucose tracer data) • Lipid oxidation (assessed by indirect calorimetry) • Insulin resistance according to the homeostatic model assessment (HOMA-IR) index • Beta cell function (assessed by arginine-stimulation test) Differences between patients treated with TCS and TCI matched controls in: • Serum/plasma concentrations of insulin, C-peptide, glucagon, free fatty acids (FFA), high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), tumor necrosis factor-a (TNF-a) • Liver status (assessed by plasma levels of transaminases and fibro scanning) • Assessment of internal corticosteroid exposure by urine sampling and skin tape striping that will undergo analysis with high-performance liquid chromatography (HPLC). • Skin barrier status and possible differential improvement and effects (assessed using skin tape strip analysis for amino acids (filaggrin degradation products), and inflammatory biomarkers of relevance to AD (including but not limited to CCL-17, IL-1, IL-4, IL-13, IL-22) • Analysis of T-cell phenotype by flow cytometry and single cell sequencing • Microbiome analysis: Investigation of different treatment effects on the composition of skin bacteria (assessed using skin and nasal swaps for sequencing bacterial microbiome DNA) • AD severity (evaluated by VAS for itch intensity and sleep disturbance, EASI, DLQI, POEM • Transepidermal water | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology
Gentofte Hospital
Outcome results
None listed