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A Clinical Study of Sub-clinical Enthesitis in Patients With Psoriasis and Healthy Controls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209894
Recruitment Status : Active, not recruiting
First Posted : December 24, 2019
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Duygu Karamanlıoğlu, Fatih Sultan Mehmet Training and Research Hospital

Brief Summary:
A clinical study of subclinical enthesitis in patients with psoriasis and healthy controls

Condition or disease Intervention/treatment
Enthesitis Diagnostic Test: Ultrasound

Detailed Description:
A total of 30 patients with psoriasis and 30 age-matched healthy controls, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded ultrasound (US) evaluation. Clinical assessment included demographics, severity of psoriasis and musculoskeletal clinical examination. Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Subclinical Enthesitis in Psoriasis Patients Without Musculoskeletal Complaints and Healthy Controls by Ultrasonography and Incidence of Enthesitis Development During 6 Months
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis Ultrasound

Group/Cohort Intervention/treatment
Psoriasis
They will undergo dermatological assessment and a blinded ultrasound (US) evaluation.
Diagnostic Test: Ultrasound
Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities

Control
They will also undergo dermatological assessment and a blinded ultrasound (US) evaluation.
Diagnostic Test: Ultrasound
Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities




Primary Outcome Measures :
  1. Subclinical Enthesitis in psoriasis patients without musculoskeletal complaints and healthy controls by ultrasonography and incidence of enthesitis development during 6 months [ Time Frame: 6 months. ]
    Incidence of subclinical enthesitis To investigate the incidence of subclinical enthesitis in patients with psoriasis


Secondary Outcome Measures :
  1. Number of participants with Risk factors of subclinical enthesitis [ Time Frame: 6 months ]
    To find out predictor factors of subclinical enthesitis in patients with psoriasis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Both patients with psoriasis and healthy controls.
Criteria

Inclusion Criteria:

  • Age≥18years
  • Patients with psoriasis without musculoskeletal symptoms
  • Healthy controls
  • No joint involvement and no clinical symptoms and signs of enthesitis and synovitis

Exclusion Criteria:

  • Have history of gout or arthritis or peripheral neurological disease of lower extremity.
  • Have history of trauma and intensive sport activity in last 2 weeks.
  • Have received any systemic therapy (i.e. DMARD, NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
  • Pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209894


Locations
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Turkey
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Atasehir, Turkey, 34758
Sponsors and Collaborators
Fatih Sultan Mehmet Training and Research Hospital
Investigators
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Principal Investigator: Duygu Silte Karamanlioglu, MD Fatih Sultan Mehmet Training and Research Hospital
Study Chair: Feyza Unlu Ozkan, Assoc. Prof. Fatih Sultan Mehmet Training and Research Hospital
Study Chair: Eylem Ceren Arikan, MD Fatih Sultan Mehmet Training and Research Hospital
Study Chair: Gulcan Ozturk, MD Fatih Sultan Mehmet Training and Research Hospital
Study Director: İlknur Aktas, Prof. Fatih Sultan Mehmet Training and Research Hospital
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Responsible Party: Duygu Karamanlıoğlu, Principal Investigator, Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04209894    
Other Study ID Numbers: karamanlioglu.duygu
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duygu Karamanlıoğlu, Fatih Sultan Mehmet Training and Research Hospital:
enthesitis
psoriasis
ultrasound
Additional relevant MeSH terms:
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Enthesopathy
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries