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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04709354
Other study ID # 54022451-050.06.06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 20, 2021

Study information

Verified date December 2021
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 20, 2021
Est. primary completion date November 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


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.

Locations

Country Name City State
Turkey Bezmialem Vakif Univesity Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Wanniang N, Navya A, Pai V, Ghodge R. Comparative Study of Clinical and Dermoscopic Features in Nail Psoriasis. Indian Dermatol Online J. 2020 Jan 13;11(1):35-40. doi: 10.4103/idoj.IDOJ_51_19. eCollection 2020 Jan-Feb. — View Citation

Yorulmaz A, Artuz F. A study of dermoscopic features of nail psoriasis. Postepy Dermatol Alergol. 2017 Feb;34(1):28-35. doi: 10.5114/ada.2017.65618. Epub 2017 Feb 7. — View Citation

Zabotti A, Errichetti E, Zuliani F, Quartuccio L, Sacco S, Stinco G, De Vita S. Early Psoriatic Arthritis Versus Early Seronegative Rheumatoid Arthritis: Role of Dermoscopy Combined with Ultrasonography for Differential Diagnosis. J Rheumatol. 2018 May;45 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparation of clinical features of nails 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
Primary Comparation of dermoscopic features of nails 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
Primary NAPSI (Psoriasis Area and Severity index) 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
Primary PASI (Psoriasis Area and Severity Index) 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 Demographic characteristics Demographic characteristics of patients will be compared. through study completion, an average of 6 months
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