Plaque PsoriasisNCT06579976
Multimodal High-frequency Ultrasound-based Study of Plaque Psoriasis Severity Index
An observational study of Plaque Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-75 years with plaque psoriasis who meet inclusion and exclusion criteria
Who may be able to join
- Patients who meet the medical criteria for plaque psoriasis
- Those who voluntarily participate in this study and sign the informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality, 200080
Xin Li, 13661956326, 13661956326@163.com
About this study
Official title: 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.
Read the 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
- Conditions
- Plaque Psoriasis
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study, no intervention will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| psoriasis lesion area | Assessment of lesions in patients with plaque psoriasis using high-frequency ultrasound and local PASI scores Receives: Other: No intervention | |
| non-psoriasis lesion area | Assessment of 2 cm next to lesions in patients with plaque psoriasis using high-frequency ultrasound Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Frequency Ultrasound
epidermal thickness (unit mm) detected by Grayscale ultrasound
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Measurement of the patient's lesion and non-lesion areas were taken once 1 day
Secondary outcomes (1)
Localized PASI
Same scoring criteria as PASI scores without area factors.
Measured: Measurement of the patient's lesion areas were taken once 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579976
- Sponsor's protocol ID
- 20230701
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal High-frequency Ultrasound-based Study of Plaque Psoriasis Severity Index：a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06579976
- Acronym / sponsor ID
- 20230701
- Conditions
- Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psoriasis lesion area | – | Other: No interventionAssessment of lesions in patients with plaque psoriasis using high-frequency ultrasound and local PASI scores |
| non-psoriasis lesion area | – | Other: No interventionAssessment of 2 cm next to lesions in patients with plaque psoriasis using high-frequency ultrasound |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-75 years with plaque psoriasis who meet inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Patients who meet the medical criteria for plaque psoriasis
- Those who voluntarily participate in this study and sign the informed consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study, no intervention will be implemented. | Other | non-psoriasis lesion area, psoriasis lesion area |
Primary outcome
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
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
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
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
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
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
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
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
1 secondary outcome
Localized PASI
Time frame: Measurement of the patient's lesion areas were taken once 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Li, PhD (13661956326, 13661956326@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Frequency Ultrasound (time frame: Measurement of the patient's lesion and non-lesion areas were taken once 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.