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

Phase 4

Completed

• Conditions: Atopic Dermatitis; Atopic Eczema
• Interventions: Drug: Protopic, tacrolimus ointment 0.1%; Drug: Betnovate, betamethasone dipropionate ointment 0.1% and placebo

• Registration Number: NCT04114097
• Lead Sponsor: Jacob Thyssen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-22
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-03
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus ointment	Protopic, tacrolimus ointment 0.1%	Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%)
Betamethasone-17-valerat + placebo ointment	Betnovate, betamethasone dipropionate ointment 0.1% and placebo	Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing corticosteroid ("Betnovate", betamethasone dipropionate ointment 0.1%) and placebo

Primary Outcome Measures

Name	Time	Method
Change in whole-body insulin sensitivity	Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly	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)).

Trial Locations

Locations (1)

Department of Dermatology and Allergy; 🇩🇰 Hellerup, Region Hovedstaden, Denmark