The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis
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|ClinicalTrials.gov Identifier: NCT01460069|
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: liraglutide Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of GLP-1 in Psoriasis|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
|Active Comparator: Victoza treatment||
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.
Placebo Comparator: Placebo
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.
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.
- PASI (psoriasis area and severity index) [ Time Frame: Baseline and after 2 months ]
- DLQI (dermatology life quality index) [ Time Frame: Baseline and after 2 months ]
- Body mass index [ Time Frame: Baseline and after 2 months ]
- CRP [ Time Frame: Baseline and after 2 months ]
- Skin biopsies [ Time Frame: Baseline and after 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460069
|Hellerup, Denmark, 2900|
|Principal Investigator:||AnneSofie Faurschou, MD PhD||Gentofte Hospital|