The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover

Atopic Dermatitis Clinical Trial

Official title:

The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114097
• Other study ID #: H-18064175
• Status: Completed
• Phase: Phase 4
• Start date: August 22, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of type 2 diabetes and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with topical corticosteroid treatment. Using state-of-the-art methodology, the present study will delineate the impact of topical corticosteroid use on insulin sensitivity and bone turnover markers in patients with atopic dermatitis and, thus, provide important data that may have implications for millions of people using topical corticosteroids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria

• Age 18-75 years

• AD according to the Hanifin and Rajka Criteria24

• AD for at least 3 years

• BMI = 30 kg/m2

• Haemoglobin A1c (HbA1c) = 42 mmol/mol (6.0%)

• Normal haemoglobin (men: 8.3-10.5 mmol/L and women 7.3-9.5 mmol/L. A 5% deviation will be allowed if the patient besides this is healthy)

• Informed consent

• In general patients should not be diagnosed with diseases that may affect or be affected by the study/treatment (evaluated by a doctor) (such as untreated skin infections, acne vulgaris (beside face region), a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease, congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression, and Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. Further patients should not suffer from kidney or liver disease/insufficiency. See the SPC for Protopic and Betnovate.)

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 (a urine test will be done at every visit and birth control is required, see below*)

• 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

• Hypersensitivity to Protopic or Betnovate

Related Conditions & MeSH terms

• Atopic Dermatitis
• Atopic Eczema
• Dermatitis
• Dermatitis, Atopic
• Insulin Resistance

Intervention

Drug:
• Betnovate, betamethasone dipropionate ointment 0.1% and placebo
Explore the systemic effects of Betnovate
• Protopic, tacrolimus ointment 0.1%
Compare the systemic effects of Betnovate to Protopic

Locations

Country	Name	City	State
Denmark	Department of Dermatology and Allergy	Hellerup	Region Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
Jacob Thyssen	LEO Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in whole-body insulin sensitivity	Change in whole-body insulin sensitivity during treatment with topical corticosteroid use compared to the control group treated with topical calcineurin inhibitors. Insulin sensitivity will be assessed by the hyperinsulinaemic euglycaemic clamp method with glucose and glycerol tracer and indirect calorimetry (rate of disappearance (Rd)).	Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly