GLP-1 Receptors in Normal Skin and Skin From Patients With Psoriasis

Plain-language guide to NCT01451905: not phased randomized trial of Liraglutide, psoriasis and psoriatic arthritis, 12 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01451905
Phase: not phased
Status: status unknown
Start: 2011-08
Completion (planned or actual): 2012-12
Participants: 12 (estimated)
Design: randomized, quadruple-blind
Conditions studied: Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Liraglutide for psoriasis and psoriatic arthritis.

To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans with no skin disease.

It had two arms (groups): Psoriasis (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

12 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Caucasians above 18 years of age. PASI score \>10. No treatment or stable treatment of psoriasis during at least 3 months before inclusion. Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2. Normal blood pressure.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: psoriasis arthritis; type 1 diabetes; treatment for type 2 diabetes with glp-1-based medicine (ddp-4-inhibitors or glp-1-receptor-agonists).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The psoriasis and psoriatic arthritis participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

The Liraglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the psoriasis and psoriatic arthritis participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-08 with completion listed for 2012-12.

It ran at 1 site in Denmark.

What Was Measured

Researchers chose this as the main measure: Changes in PASI and DLQI (time frame: 2 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 12 people with psoriasis and psoriatic arthritis.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Psoriasis and psoriatic arthritis research.

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.