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

Primary Purpose

Atopic Dermatitis, Atopic Eczema

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Betnovate, betamethasone dipropionate ointment 0.1% and placebo

Protopic, tacrolimus ointment 0.1%

About this trial

This is an interventional other trial for Atopic Dermatitis focused on measuring topical corticosteroids, topical calcineurin inhibitors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Dermatology and Allergy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Betamethasone-17-valerat + placebo ointment

Tacrolimus ointment

Arm Description

Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing corticosteroid ("Betnovate", betamethasone dipropionate ointment 0.1%) and placebo

Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%)

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

Full Information

NCT ID

NCT04114097

First Posted

October 1, 2019

Last Updated

April 27, 2021

Sponsor

Jacob Thyssen

Collaborators

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT04114097

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

August 22, 2019 (Actual)

Primary Completion Date

March 15, 2021 (Actual)

Study Completion Date

March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jacob Thyssen

Collaborators

LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis, Atopic Eczema

Keywords

topical corticosteroids, topical calcineurin inhibitors

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

randomised, two-arm, active comparator, double-dummy, double-blinded trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Betamethasone-17-valerat + placebo ointment

Arm Type

Experimental

Arm Description

Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing corticosteroid ("Betnovate", betamethasone dipropionate ointment 0.1%) and placebo

Arm Title

Tacrolimus ointment

Arm Type

Active Comparator

Arm Description

Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%)

Intervention Type

Drug

Intervention Name(s)

Betnovate, betamethasone dipropionate ointment 0.1% and placebo

Intervention Description

Explore the systemic effects of Betnovate

Intervention Type

Drug

Intervention Name(s)

Protopic, tacrolimus ointment 0.1%

Intervention Description

Compare the systemic effects of Betnovate to Protopic

Primary Outcome Measure Information:

Title

Change in whole-body insulin sensitivity

Description

Time Frame

Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacob P Thyssen, Professor, MD, DMSc

Organizational Affiliation

Department of Dermatology and Allergy, Gentofte Hospital, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology and Allergy

City

Hellerup

State/Province

Region Hovedstaden

ZIP/Postal Code

2900

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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