| Trial ID: | L6881 |
| Source ID: | NCT04114097
|
| Associated Drug: |
Betnovate, Betamethasone Dipropionate Ointment 0.1% And Placebo
|
| Title: |
The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Atopic Dermatitis|Atopic Eczema
|
| Interventions: |
DRUG: Betnovate, betamethasone dipropionate ointment 0.1% and placebo|DRUG: Protopic, tacrolimus ointment 0.1%
|
| Outcome Measures: |
Primary: 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))., Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly |
|
| Sponsor/Collaborators: |
Sponsor: Jacob Thyssen | Collaborators: LEO Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
|
| Start Date: |
2019-08-22
|
| Completion Date: |
2021-03-15
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| Results First Posted: |
|
| Last Update Posted: |
2021-04-28
|
| Locations: |
Department of Dermatology and Allergy, Hellerup, Region Hovedstaden, 2900, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT04114097
|
