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

NCT ID: NCT06579976

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-05-01

Brief Summary

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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

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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

Conditions

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Plaque Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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psoriasis lesion area

Assessment of lesions in patients with plaque psoriasis using high-frequency ultrasound and local PASI scores

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

Interventions

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No intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xin Li, PhD

Role: CONTACT

Phone: 13661956326

Email: [email protected]

Yuanting Yu, bachelor

Role: CONTACT

Phone: 19518322901

Email: [email protected]

Facility Contacts

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Xin Li

Role: primary

Other Identifiers

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20230701

Identifier Type: -

Identifier Source: org_study_id