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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

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.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

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.

NCT04709354
Phase

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.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bezmialem Vakif University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nahide MD Onsun, ProfBegüm MD Güneş
Principal Investigator Affiliation Bezmialem UniversityBezmialem University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Circinata, Psoriatic Arthritis, Rheumatoid Arthritis, Spondylarthropathies, Psoriatic Nail
Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

: 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.

: 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.

Interventions

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.

Contact a Trial Team

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International Sites

Bezmialem Vakıf Univesity, Istanbul, Turkey

Status

Recruiting

Address

Bezmialem Vakıf Univesity

Istanbul, , 34093

Site Contact

Nahide MD Onsun, Prof

[email protected]

2124531700 #1131

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