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History of Changes for Study: NCT04114097
The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover
Latest version (submitted April 27, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 2, 2019 None (earliest Version on record)
2 October 31, 2019 Outcome Measures, Arms and Interventions, Study Description and Study Status
3 April 27, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT04114097
Submitted Date:  October 2, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: H-18064175
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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2019
Overall Status: Recruiting
Study Start: August 22, 2019
Primary Completion: October 1, 2020 [Anticipated]
Study Completion: March 1, 2021 [Anticipated]
First Submitted: October 1, 2019
First Submitted that
Met QC Criteria:
October 2, 2019
First Posted: October 3, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
October 2, 2019
Last Update Posted: October 3, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Jacob Thyssen
Responsible Party: Sponsor-Investigator
Investigator: Jacob Thyssen
Official Title: Professor, consultant
Affiliation: University Hospital, Gentofte, Copenhagen
Collaborators: LEO Pharma
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of T2D and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with TCS treatment. Using state-of-the-art methodology, the present study will delineate the impact of TCS on insulin sensitivity and bone turnover markers in patients with AD and, thus, provide important data that may have implications for millions of people using TCS.
Detailed Description:
Open or close this module Conditions
Conditions: Atopic Dermatitis
Atopic Eczema
Keywords: topical corticosteroids
topical calcineurin inhibitors
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
randomised, two-arm, active comparator, double-dummy, double-blinded trial
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Betamethasone-17-valerat + placebo ointment
Atopic dermaitits patients: topical treatment with twice daily full-body ointment containing corticosteroid ("Betnovate", betamethasone dipropionate ointment 0.1%) and placebo
Drug: Betnovate, betamethasone dipropionate ointment 0.1% and placebo
Explore the systemic effects of Betnovate
Active Comparator: Tacrolimus ointment
Atopic dermaitits patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%)
Drug: Protopic, tacrolimus ointment 0.1%
Compare the systemic effects of Betnovate to Protopic
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in whole-body insulin sensitivity
Change in whole-body insulin sensitivity during treatment with TCS compared to the control group treated with TCI. Insulin sensitivity will be assessed by the hyperinsulinaemic euglycaemic clamp method with glucose and glycerol tracer and indirect calorimetry (rate of disappearance (Rd)).

[Time Frame: Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Lise Gether, MD
Telephone: +4591175147
Email: lise.gether.01@regionh.dk
Study Officials: Jacob P Thyssen, Professor, MD, DMSc
Principal Investigator
Department of Dermatology and Allergy, Gentofte Hospital, Denmark
Locations: Denmark, Region Hovedstaden
Department of Dermatology and Allergy
[Recruiting]
Hellerup, Region Hovedstaden, Denmark, 2900
Contact:Contact: Hudsygdomme Klinik +4538673211
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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