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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Victoza treatment | Active Comparator |
| |
| Placebo | Placebo Comparator | The placebo pens contain saline and are administered in the same way and volume as Victoza. The placebo pens are specially prepared for this study and will be used in the study only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylenglycol, and phenol for conservation (pH 8.15). Commercial pens will be used and the information given in the packaging will be applicable. The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. The injection is administered once daily in the morning. The maximal plasma concentration is reached 8-12 hours after subcutaneous injection. The half-life in plasma is approximately 13 hours. The duration of effect is 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| PASI (psoriasis area and severity index) | Baseline and after 2 months | |
| DLQI (dermatology life quality index) | Baseline and after 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | Baseline and after 2 months | |
| CRP | Baseline and after 2 months | |
| Skin biopsies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AnneSofie Faurschou, MD PhD | Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| Placebo | Drug | The placebo pens contain saline and are administered in the same way and volume as (liraglutide) Victoza. The placebo pens are specially prepared for this study and will be used in the study only. |
|
| Baseline and after 2 months |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |