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NCT Number: NCT06579976

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, 200080, China

Location contact

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. High Frequency Ultrasound

    Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day

    epidermal thickness (unit mm) detected by Grayscale ultrasound

  2. High Frequency Ultrasound

    Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day

    dermal thickness (unit mm) detected by Grayscale ultrasound

  3. High Frequency Ultrasound

    Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day

    hypoechoic cord thickness between epidermis and dermis (unit mm) detected by Grayscale ultrasound

  4. High Frequency Ultrasound

    Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day

    epidermal echo intensity detected by Grayscale ultrasound

  5. High Frequency Ultrasound

    Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day

    dermal echo intensity detected by Grayscale ultrasound

  6. High Frequency Ultrasound

    Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day

    clarity of the boundary between dermis and subcutaneous tissue detected by Grayscale ultrasound

  7. High Frequency Ultrasound

    Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day

    blood flow signal (pcs) detected by Color Doppler imaging

  8. High Frequency Ultrasound

    Time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day

    blood flow signal (pcs) detected by Power doppler imaging

Secondary outcomes

  1. Localized PASI

    Time frame: Measurement of the patient's lesion areas were taken once 1 day

    Same scoring criteria as PASI scores without area factors.

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Li, PhD

CONTACT

[email protected]

13661956326

Yuanting Yu, bachelor

CONTACT

[email protected]

19518322901

Sponsors and collaborators

Lead sponsor

Shanghai Yueyang Integrated Medicine Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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