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Not yet recruiting NCT06579976

Multimodal High-frequency Ultrasound-based Study of Plaque Psoriasis Severity Index

— Observational Plaque Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Plaque Psoriasis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Multimodal High-frequency Ultrasound-based Study of Plaque Psoriasis Severity Index：a Prospective Cohort Study

Overview

Psoriasis (PsO) is a common chronic relapsing inflammatory disease, induced by a combination of genetic and environmental effects, which seriously affects the quality of life of patients.Psoriasis Area and Severity Index（PASI score ） ，as the most common method used by clinicians to assess the severity of psoriasis and the effectiveness of treatment, has the disadvantage of being subjective and superficial.We are therefore committed to establishing an objective, real-time, repeatable, non-invasive, microscopic assessment using high-frequency ultrasound. This study will use high-frequency ultrasound to detect the patient's lesion site and the 2cm site next to the lesion once, and the study will continue to recruit for 6 months.

Detailed description

High-frequency ultrasound (HFUS) with a center frequency of more than 10 MHz, and a resolution of 16-158 μm. The detailed detection items are epidermal thickness (unit mm), dermal thickness (unit mm), hypoechoic cord thickness between epidermis and dermis (unit mm), epidermal echo intensity, dermal echo intensity, clarity of the boundary between dermis and subcutaneous tissue detected by Grayscale ultrasound; blood flow signal (pcs) detected by Color Doppler imaging and Power doppler imaging. The 8 tests will be detected the skin lesions and 2cm beside skin lesions area.Based on the correlation between the 8 indexes and local PASI scores, we will establish a model for the evaluation of psoriasis by multimodal high-frequency ultrasound.This study will use high-frequency ultrasound to detect the patient's lesion site and the 2cm site next to the lesion once, and the study will continue to recruit for 6 months

Interventions

  • Other No intervention
    This is an observational study, no intervention will be implemented.

Primary outcome measures

  • High Frequency Ultrasound [Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
  • High Frequency Ultrasound [Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day]
Secondary outcome measures (1)
  • Localized PASI [Time frame: Measurement of the patient's lesion areas were taken once 1 day]

Eligibility criteria

Inclusion criteria

  • Patients who meet the medical criteria for plaque psoriasis
  • Those who voluntarily participate in this study and sign the informed consent form

Exclusion criteria

  • Patients with other types of psoriasis
  • Those with other active medical conditions that may affect assessment
  • During a severe uncontrollable acute or chronic local or systemic infection
  • Those with severe mental illness, cognitive impairment, and incapacity for personal behavior that makes them unsuitable to participate in a clinical study
  • Other reasons the investigator considers unsuitable for participation in this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shanghai Yueyang Integrated Medicine Hospital — Shanghai

Identifiers

NCT: NCT06579976 · 20230701

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗