Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Age≥18years.
- - Patients with psoriasis without musculoskeletal symptoms.
- - Healthy controls.
- - No joint involvement and no clinical symptoms and signs of enthesitis and synovitis.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Fatih Sultan Mehmet Training and Research Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Duygu Silte Karamanlioglu, MDFeyza Unlu Ozkan, Assoc. Prof.Eylem Ceren Arikan, MDGulcan Ozturk, MDİlknur Aktas, Prof.|
|Principal Investigator Affiliation||Fatih Sultan Mehmet Training and Research HospitalFatih Sultan Mehmet Training and Research HospitalFatih Sultan Mehmet Training and Research HospitalFatih Sultan Mehmet Training and Research HospitalFatih Sultan Mehmet Training and Research Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
They will undergo dermatological assessment and a blinded ultrasound (US) evaluation.
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
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