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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Other: No intervention

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

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Xin Li, PhD; Phone Number: 13661956326; Email: 13661956326@163.com
• Study Contact Backup: Name: Yuanting Yu, bachelor; Phone Number: 19518322901; Email: yyt06271023@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai Yueyang Integrated Medicine Hospital
      • Contact: Xin Li; Phone Number: 13661956326; Email: 13661956326@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-75 years with plaque psoriasis who meet inclusion and exclusion criteria

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
psoriasis lesion area; Assessment of lesions in patients with plaque psoriasis using high-frequency ultrasound and local PASI scores	Other: No intervention; This is an observational study, no intervention will be implemented.
non-psoriasis lesion area; Assessment of 2 cm next to lesions in patients with plaque psoriasis using high-frequency ultrasound	Other: No intervention; This is an observational study, no intervention will be implemented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Frequency Ultrasound	epidermal thickness (unit mm) detected by Grayscale ultrasound	Measurement of the patient's lesion and non-lesion areas were taken once 1 day
High Frequency Ultrasound	dermal thickness (unit mm) detected by Grayscale ultrasound	Measurement of the patient's lesion and non-lesion areas were taken once 1 day
High Frequency Ultrasound	hypoechoic cord thickness between epidermis and dermis (unit mm) detected by Grayscale ultrasound	Measurement of the patient's lesion and non-lesion areas were taken once 1 day
High Frequency Ultrasound	epidermal echo intensity detected by Grayscale ultrasound	Measurement of the patient's lesion and non-lesion areas were taken once 1 day
High Frequency Ultrasound	dermal echo intensity detected by Grayscale ultrasound	Measurement of the patient's lesion and non-lesion areas were taken once 1 day
High Frequency Ultrasound	clarity of the boundary between dermis and subcutaneous tissue detected by Grayscale ultrasound	Measurement of the patient's lesion and non-lesion areas were taken once 1 day
High Frequency Ultrasound	blood flow signal (pcs) detected by Color Doppler imaging	Measurement of the patient's lesion and non-lesion areas were taken once 1 day
High Frequency Ultrasound	blood flow signal (pcs) detected by Power doppler imaging	Measurement of the patient's lesion and non-lesion areas were taken once 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localized PASI	Same scoring criteria as PASI scores without area factors.	Measurement of the patient's lesion areas were taken once 1 day

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 20230701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No