A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis

January 14, 2015 updated by: The 306 Hospital of People's Liberation Army
A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A total of 100 patients with vulgaris psoriasis and 100 age-matched controls with other skin diseases, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded PDUS evaluation. Clinical assessment included demographics, severity of psoriasis, musculoskeletal clinical examination and sport activities. PDUS evaluation consisted of the detection of grey scale (GS) synovitis and synovial PD signal in joints of extremities, GS enthesopathy and entheseal PD signal in entheses of lower limbs.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Both patients with psoriasis and patients with other skin diseases

Description

Inclusion Criteria:

  • age≥18years
  • patients with vulgaris psoriasis(dur
  • patients with other skin diseases without musculoskeletal disorders
  • no joint involvement and no clinical symptoms and signs of enthesitis and synovitis

Exclusion Criteria:

  • BMI≥24
  • have history of gout or arthritis or peripheral neurological disease of lower extremity or trauma
  • have received any systemic therapy(i.e.NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
  • pregnant or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case group
100 patients with vulgaris psoriasi without arthritis
Other: PDUS examination
control group
100 age-matched patients with other skin diseases without arthritis
Other: PDUS examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of subclinical enthesitis and synovitis
Time Frame: one and a half year
To investigate the incidence of subclinical enthesitis and synovitis in patients with vulgaris
one and a half year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Risk factors of subclinical enthesitis and synovitis
Time Frame: one and a half year
To find out predictor factors of subclinical enthesitis and synovitis in patients with vulgaris psoriasis
one and a half year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The 306 Hospital of People's Liberation Army

Investigators

  • Principal Investigator: Jianjun Liu, M.D., The 306 Hospital of People's Liberation Army

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306PLA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vulgaris Psoriasis

Clinical Trials on PDUS examination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe