NCT04709354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

January 11, 2021

Last Update Submit

December 20, 2021

Conditions

Keywords

PsoriasisPsoriatic ArthritisPsoriatic NailDermoscopy

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Demographic characteristics

    through study completion, an average of 6 months

Study Arms (4)

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

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

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

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

Interventions

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 spondylopathypsoriasis patients without joint involvementpsoriatic arthritisrheumatoid arthritis patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf Univesity

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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(5):648-654. doi: 10.3899/jrheum.170962. Epub 2018 Feb 15.

MeSH Terms

Conditions

Arthritis, PsoriaticArthritis, RheumatoidSpondylarthropathiesPsoriasis

Condition Hierarchy (Ancestors)

SpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nahide MD Onsun, Prof

    Bezmialem University

    STUDY DIRECTOR
  • Begüm MD Güneş

    Bezmialem University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 14, 2021

Study Start

January 1, 2021

Primary Completion

November 20, 2021

Study Completion

December 20, 2021

Last Updated

December 22, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations