An observational study in Psoriasis (PsO), Psoriatic Arthritis and Palmoplantar Pustulosis (PPP), sponsored by Shanghai Yueyang Integrated Medicine Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Observational
Psoriasis is a globally prevalent chronic relapsing skin disease, characterized by its long duration and tendency to relapse. In addition to skin symptoms, it can also affect nails and joints, leading to pathological features such as pitting, leukonychia, red lunula, or severe nail dystrophy. Some patients with psoriasis may develop psoriatic arthritis. Psoriatic arthritis (PsA) is a chronic relapsing musculoskeletal disease, characterized by psoriatic skin lesions accompanied by axial and peripheral joint damage, and often associated with characteristic manifestations of psoriatic nails. These nail changes typically indicate more severe disease and poorer prognosis. However, current diagnostic methods largely depend on the experience and professional knowledge of clinicians, which are subjective and uncertain. Moreover, histopathological examination is invasive and can cause additional pain and inconvenience to patients.
To develop an effective, convenient, and non-invasive early diagnostic tool for psoriasis, our research team has conducted in-depth studies in the field of psoriasis-related diagnosis and predictive models. We have successfully developed a predictive model for psoriatic arthritis, including six key predictive factors: history of joint swelling, history of arthritis, history of swelling and pain in fingers or toes, nail involvement, genital involvement, and a history of long-term local use of corticosteroids. Clinicians can effectively assess the risk of psoriatic arthritis by obtaining information about these six factors from patients. The paper "Early detection of psoriatic arthritis in patients with psoriasis: construction of a multifactorial prediction model" was published in Front. Immunol (DOI: 10.3389/fimmu.2024.1426127).
Raman spectroscopy is a rapid, non-invasive molecular vibration detection method that has shown great potential in medical diagnostics. Studies have shown that Raman spectroscopy can distinguish normal and abnormal tissues at the molecular level and has been proven feasible in nail testing. For psoriasis, a disease that causes significant nail changes, Raman spectroscopy offers unique advantages.
Based on this background, our project will conduct a prospective observational study on psoriasis and psoriatic arthritis using multidimensional nail data. We will integrate Raman spectroscopy data of nails and multidimensional clinical information and apply artificial intelligence algorithms to develop a new diagnostic tool for psoriasis and psoriatic arthritis. This tool aims to improve the accuracy and efficiency of diagnosis, providing strong support for the early detection and precise treatment of psoriasis and psoriatic arthritis.
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's planned enrollment of 310 is close to the median of 300 across 243 observational studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 38 studies on the registry; 15 are open to participants now.
Compared within Arthritis, Psoriatic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psoriasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
This study plans to select and include 155 patients with psoriasis from those visiting the Department of Dermatology at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, as the experimental group. Additionally, 155 patients who visit for non-psoriasis skin conditions such as eczema or acne, and have been professionally diagnosed and confirmed by doctors not to have psoriasis, will be chosen as the control group.
Inclusion Criteria:
-
Inclusion criteria for patients with psoriasis:
Inclusion criteria for non-psoriasis control subjects:
(1) Patients who visit for other non-psoriasis skin conditions such as eczema or acne, and are confirmed by dermatologists not to have psoriasis; (3) Age ≥ 18 and ≤ 80 years, with no gender restrictions; (4) Consent to participate in this study and sign an informed consent form.
-
Exclusion criteria for patients with psoriasis:
Exclusion criteria for non-psoriasis subjects:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: No intervention
Other: No intervention
This is an observational study, no intervention will be implemented.
Raman data
Time frame: 1 day (The collected nail samples will be placed on aluminum-coated slides for Raman spectroscopic analysis, and the Raman peak data will be exported to form a txt file.)
Psoriasis Area and Severity Index (PASI)
Time frame: The researcher conducted a Psoriasis Area and Severity Index (PASI) assessment on the psoriasis subjects on the 1 day of sample collection.
Body Surface Area (BSA)
Time frame: The researcher conducted a Body Surface Area (BSA) assessment on the psoriasis subjects on the 1 day of sample collection.
Modified Nail Psoriasis Severity Index (mNAPSI)
Time frame: The researcher conducted a Modified Nail Psoriasis Severity Index (mNAPSI) assessment on the psoriasis subjects on the 1 day of sample collection.
Classification of Psoriatic Arthritis (CASPAR)
Time frame: The researcher conducted a Classification of Psoriatic Arthritis (CASPAR) assessment on the psoriasis subjects on the 1 day of sample collection.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Yueyang Integrated Medicine Hospital