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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betamethasone-17-valerat + placebo ointment | Experimental | Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing corticosteroid ("Betnovate", betamethasone dipropionate ointment 0.1%) and placebo |
|
| Tacrolimus ointment | Active Comparator | Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betnovate, betamethasone dipropionate ointment 0.1% and placebo | Drug | Explore the systemic effects of Betnovate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jacob P Thyssen, Professor, MD, DMSc | Department of Dermatology and Allergy, Gentofte Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology and Allergy | Hellerup | Capital Region | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42126851 | Derived | Amiri D, Hellmann PH, Thyssen JP, Skov L, Kolko M, Gether L. Intraocular Pressure During Short-Term Topical or Systemic Corticosteroid Treatment: Analysis of 3 Randomized Clinical Trials. JAMA Dermatol. 2026 May 13:e261183. doi: 10.1001/jamadermatol.2026.1183. Online ahead of print. | |
| 36824052 | Derived | Gether L, Storgaard H, Kezic S, Jakasa I, Hartmann B, Skov-Jeppesen K, Holst JJ, Pedersen AJ, Forman J, van Hall G, Sorensen OE, Skov L, Ropke MA, Knop FK, Thyssen JP. Effects of topical corticosteroid versus tacrolimus on insulin sensitivity and bone homeostasis in adults with atopic dermatitis-A randomized controlled study. Allergy. 2023 Jul;78(7):1964-1979. doi: 10.1111/all.15690. Epub 2023 Mar 21. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D001624 | Betamethasone Valerate |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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randomised, two-arm, active comparator, double-dummy, double-blinded trial
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| Protopic, tacrolimus ointment 0.1% | Drug | Compare the systemic effects of Betnovate to Protopic |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |