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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06579976
Enrollment
45
Registered
2024-08-30
Start date
2024-09-01
Completion date
2025-05-01
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Brief summary

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

OTHERNo intervention

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

Sponsors

Shanghai Yueyang Integrated Medicine Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
High Frequency UltrasoundMeasurement of the patient's lesion and non-lesion areas were taken once 1 dayepidermal thickness (unit mm) detected by Grayscale ultrasound

Secondary

MeasureTime frameDescription
Localized PASIMeasurement of the patient's lesion areas were taken once 1 daySame scoring criteria as PASI scores without area factors.

Countries

China

Contacts

Primary ContactXin Li, PhD
13661956326@163.com13661956326
Backup ContactYuanting Yu, bachelor
yyt06271023@163.com19518322901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026