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

December 20, 2021 updated by: Bezmialem Vakif University

Clinical and Dermoscopic Evaluation of Nail Findings of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis Patients and Comparison With Psoriasis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

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

  • Turkey
      • Istanbul, Turkey, 34093
        • Bezmialem Vakıf Univesity

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

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

Description

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

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
six months
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.
six months
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.
six months
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.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic characteristics
Time Frame: through study completion, an average of 6 months
Demographic characteristics of patients will be compared.
through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

Bezmialem Vakif University

Investigators

  • Study Director: Nahide MD Onsun, Prof, Bezmialem University
  • Principal Investigator: Begüm MD Güneş, Bezmialem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2021

Primary Completion (Actual)

November 20, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54022451-050.06.06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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