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Effect of Semaglutide on the Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus

Plain-language guide to NCT06475586: phase 4 randomized trial of Semaglutide, psoriasis and psoriatic arthritis, 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06475586
Phase
phase 4
Status
completed
Start
2023-05-03
Completion (planned or actual)
2024-03-01
Participants
30 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Psoriasis Vulgaris; Diabetes Type 2
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Semaglutide for psoriasis and psoriatic arthritis.

It had two arms (groups): semaglutide (experimental) and controled group (no intervention).

The registry classes the interventions as drug.

More on the Plan

After being informed about the study and potential risiks all patients giving written informed consent will undergo a 1-week screening period to determine eliglibility for study entry at week 0, patients who meet the eligibility requirements will be randomized.

Study was conducted in two cohort Cohort 1.

Who Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Patients who signed a personal consent to participate in the study,. Patients with a typical clinical picture of moderately-severe to severe plaque psoriasis (PASI SCORE ≥10) and. DMT2 diagnosed at least 6 months before inclusion in the study,. Patients who were not treated with immunosuppressive therapy.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: other forms of psoriasis,; other chronic, inflammatory diseases (data obtained by reviewing the medical history),; drugs that can cause the appearance of psoriasis (lithium, systemic antimalarials, systemic corticosteroids) - for the past 3 months,.

How the Study Was Run

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

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-05-03 with completion listed for 2024-03-01.

It ran at 1 site in Bosnia and Herzegovina.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): clinical characteristics of patients with psoriasis (time frame: up to 12 weeks). Determine BMI Body Mass Index (time frame: up to 12 weeks). Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23 (time frame: up to12 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 30 people with psoriasis and psoriatic arthritis.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

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.