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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

Tracking Information
First Submitted Date January 11, 2021
First Posted Date January 14, 2021
Last Update Posted Date June 29, 2021
Actual Study Start Date January 1, 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2021)
  • 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
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: January 13, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: January 13, 2021)
Demographic characteristics [ Time Frame: through study completion, an average of 6 months ]
Demographic characteristics of patients will be compared.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Dermoscopic Comparison of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriasis Patients' Nails
Official Title Clinical and Dermoscopic Evaluation of Nail Findings of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis Patients and Comparison With Psoriasis Patients
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients over 18 years with psoriasis, rheumatoid arthritis, ankylosing spondylitis
Condition
  • Psoriasis Circinata
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Spondylarthropathies
  • Psoriatic Nail
Intervention 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.
Study Groups/Cohorts
  • 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.
    Intervention: Diagnostic Test: Dermoscopic examination
  • 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.
    Intervention: Diagnostic Test: Dermoscopic examination
  • 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.
    Intervention: Diagnostic Test: Dermoscopic examination
  • 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.
    Intervention: Diagnostic Test: Dermoscopic examination
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 13, 2021)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mehmet Hakan MD Özdemir, Prof +902124530453 mozdemir@bezmialem.edu.tr
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04709354
Other Study ID Numbers 54022451-050.06.06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Bezmialem Vakif University
Study Sponsor Bezmialem Vakif University
Collaborators Not Provided
Investigators
Study Director: Nahide MD Onsun, Prof Bezmialem University
Principal Investigator: Begüm MD Güneş Bezmialem University
PRS Account Bezmialem Vakif University
Verification Date June 2021