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

NCT04114097 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Betnovate, betamethasone dipropionate ointment 0.1% and placebo

Explore the systemic effects of Betnovate

DRUG

Protopic, tacrolimus ointment 0.1%

Compare the systemic effects of Betnovate to Protopic

Sponsors & Collaborators

  • LEO Pharma

    collaborator INDUSTRY
  • Jacob Thyssen

    lead OTHER

Principal Investigators

  • Jacob P Thyssen, Professor, MD, DMSc · Department of Dermatology and Allergy, Gentofte Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2021-03-15
Completion
2021-03-15

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114097 on ClinicalTrials.gov