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Clinical and Dermoscopic Comparison of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriasis Patients' Nails

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ClinicalTrials.gov Identifier: NCT04709354
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

Brief Summary:
This study evaluates the fingernail findings of the rheumatoid arthritis, spondylopathy and psoriatic arthritis patient groups with the fingernails of psoriasis patients clinically and dermatoscopically and investigates the benefit of dermoscopy in the differentiation of these patients.

Condition or disease Intervention/treatment
Psoriasis Circinata Psoriatic Arthritis Rheumatoid Arthritis Spondylarthropathies Psoriatic Nail Diagnostic Test: Dermoscopic examination

Detailed Description:

Psoriasis is a common chronic inflammatory disease with many comorbidities. Dermatologists have a very important role in the early diagnosis of psoriatic arthritis, which is one of the most important comorbidities of psoriasis. Therefore, studies have been conducted on many factors predicting the risk of psoriatic arthritis and it has been concluded that nail involvement is closely related to psoriatic arthritis.For this reason, the importance of nail examination in the follow-up of psoriasis patients has increased significantly. Nail examination should be done carefully to predict the risk of developing psoriatic arthritis, especially at the beginning of the disease and subclinical types, and dermoscopy should be used to identify patients who may be clinically uncertain.

In addition, rheumatoid arthritis and spondylopathy patients have a lot in common with psoriatic arthritis patients.In these patients, there is no clear distinction to diagnose joint involvement, and their distinction is mostly based on the presence or absence of skin findings.Nail findings have an important place among this skin findings in the diagnosis of these patients.

Based on all these, this study questions the benefit of clinical and dermoscopic examination of nail findings in the early stages to differentiate these patients, as well as comparing the nail findings and revealing the differences and similarities.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical and Dermoscopic Evaluation of Nail Findings of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis Patients and Comparison With Psoriasis Patients
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Group/Cohort Intervention/treatment
rheumatoid arthritis patient
Skin and fingernail examination of newly diagnosed (diagnosed before 1 year) rheumatoid arthritis patients will be done. A detailed dermoscopic examination will be performed on the nails of these patients.
Diagnostic Test: Dermoscopic examination
The periungual area, nail plate, subungual area of the patients' fingernails will be examined and images of the lesional nails or target nails will be recorded for comparison.

patients with spondylopathy
Skin and fingernail examination of newly diagnosed (diagnosed before 1 year) patient with spondylopathy will be done. A detailed dermoscopic examination will be performed on the nails of these patients.
Diagnostic Test: Dermoscopic examination
The periungual area, nail plate, subungual area of the patients' fingernails will be examined and images of the lesional nails or target nails will be recorded for comparison.

psoriatic arthritis
Skin and fingernail examination of patient with psoriatic arthritis will be done. A detailed dermoscopic examination will be performed on the nails of these patients. PASI and NAPSI scores of all patients will be calculated.
Diagnostic Test: Dermoscopic examination
The periungual area, nail plate, subungual area of the patients' fingernails will be examined and images of the lesional nails or target nails will be recorded for comparison.

psoriasis patients without joint involvement
Skin and fingernail examination of patient with psoriasis patients without joint involvement will be done. A detailed dermoscopic examination will be performed on the nails of these patients. PASI and NAPSI scores of all patients will be calculated.
Diagnostic Test: Dermoscopic examination
The periungual area, nail plate, subungual area of the patients' fingernails will be examined and images of the lesional nails or target nails will be recorded for comparison.




Primary Outcome Measures :
  1. Comparation of clinical features of nails [ Time Frame: six months ]
    All of patients' fingernails will be examined clinically and visible nail findings will be noted. Many findings such as onycholysis, pitting, splinter hemorrhage, nail base vascularity, leukonychia etc. will be recorded. Also, the severity of nail involvement in psoriasis patients will be measured by the NAPSI score

  2. Comparation of dermoscopic features of nails [ Time Frame: six months ]
    All of patients' fingernails will be examined by dermoscopy and nail findings will be noted. Also in particular, vascularization around the nail will be checked and images of all of the findings will be taken. Rheumatoid arthritis and spondylopathy patients with nail findings consistent with psoriasis will be enrolled.

  3. NAPSI (Psoriasis Area and Severity index) [ Time Frame: six months ]

    All psoriasis patients will be scored on their nails with NAPSI (Psoriasis Area and Severity Index) scoring system.

    The correlation of PASI and NAPSI will be examined.


  4. PASI (Psoriasis Area and Severity Index) [ Time Frame: six months ]

    Skin lesions of all psoriasis patients will be scored with the PASI (Psoriasis Area and Severity Index) system.

    The correlation of PASI and NAPSI will be examined.



Secondary Outcome Measures :
  1. Demographic characteristics [ Time Frame: through study completion, an average of 6 months ]
    Demographic characteristics of patients will be compared.



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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
Patients over 18 years with psoriasis, rheumatoid arthritis, ankylosing spondylitis
Criteria

Inclusion Criteria:

  • Psoriasis confirmed by dermatologist.
  • Rheumatoid arthritis, ankylosing spondylitis confirmed by rheumatologist (newly diagnosed).

Exclusion Criteria:

  • Unable to consent and understand
  • Patients with confirmed onychomycosis
  • Patients receiving biological therapy

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): NCT04709354


Contacts
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Contact: Mehmet Hakan MD Özdemir, Prof +902124530453 mozdemir@bezmialem.edu.tr

Locations
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Turkey
Bezmialem Vakıf Univesity Recruiting
Istanbul, Turkey, 34093
Contact: Nahide MD Onsun, Prof    2124531700 ext 1131    nonsun@bezmialem.edu.tr   
Contact: Begüm MD Güneş    +905369735616    byurtsever@bezmialem.edu.tr   
Sub-Investigator: Begüm MD Güneş         
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Study Director: Nahide MD Onsun, Prof Bezmialem University
Principal Investigator: Begüm MD Güneş Bezmialem University
Publications of Results:
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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04709354    
Other Study ID Numbers: 54022451-050.06.06
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
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 Bezmialem Vakif University:
Psoriasis
Psoriatic Arthritis
Psoriatic Nail
Dermoscopy
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Spondylarthropathies
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthritis
Ankylosis