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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2021-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis Atopic Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Betamethasone-17-valerat + placebo ointment

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

Group Type EXPERIMENTAL

Betnovate, betamethasone dipropionate ointment 0.1% and placebo

Intervention Type DRUG

Explore the systemic effects of Betnovate

Tacrolimus ointment

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

Group Type ACTIVE_COMPARATOR

Protopic, tacrolimus ointment 0.1%

Intervention Type DRUG

Compare the systemic effects of Betnovate to Protopic

Interventions

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Betnovate, betamethasone dipropionate ointment 0.1% and placebo

Explore the systemic effects of Betnovate

Intervention Type DRUG

Protopic, tacrolimus ointment 0.1%

Compare the systemic effects of Betnovate to Protopic

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No