NCT06579976

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 17, 2024

Last Update Submit

August 29, 2024

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (1)

  • Localized PASI

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

Study Arms (2)

psoriasis lesion area

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

Other: No intervention

non-psoriasis lesion area

Assessment of 2 cm next to lesions in patients with plaque psoriasis using high-frequency ultrasound

Other: No intervention

Interventions

No interventionOTHER

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

non-psoriasis lesion areapsoriasis lesion area

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Central Study Contacts

Xin Li, PhD

CONTACT

1366195632613661956326@163.com

Yuanting Yu, bachelor

CONTACT

19518322901yyt06271023@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 30, 2024

Study Start

September 1, 2024

Primary Completion

February 28, 2025

Study Completion

May 1, 2025

Last Updated

August 30, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)