Psoriasis CircinataNCT04709354
Clinical and Dermoscopic Comparison of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriasis Patients' Nails
An observational study of Psoriasis Circinata and Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Circinata, Psoriatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- Dermoscopic examination
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 18 years with psoriasis, rheumatoid arthritis, ankylosing spondylitis
Who may be able to join
- Psoriasis confirmed by dermatologist.
- Rheumatoid arthritis, ankylosing spondylitis confirmed by rheumatologist (newly diagnosed).
Who cannot join
- Unable to consent and understand
- Patients with confirmed onychomycosis
- Patients receiving biological therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis Circinata, Psoriatic Arthritis, Rheumatoid Arthritis, Spondylarthropathies, Psoriatic Nail
- Being tested
- Dermoscopic examination
- Keywords
- Psoriasis, Psoriatic Arthritis, Psoriatic Nail, Dermoscopy
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylarthropathies, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermoscopic examinationDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Dermoscopic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: six months
Secondary outcomes (1)
Demographic characteristics
Demographic characteristics of patients will be compared.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2021
- Primary completion20 Nov 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psoriasis CircinataStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nahide MD Onsun, Prof, Study director, Bezmialem UniversityBegüm MD Güneş, Principal investigator, Bezmialem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709354
- Sponsor's protocol ID
- 54022451-050.06.06
- Status last verified
- Dec 2021
- First submitted
- 11 Jan 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28286468Wanniang 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.
PubMed 32055506Zabotti 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.
PubMed 29449498
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Dermoscopic Evaluation of Nail Findings of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis Patients and Comparison With Psoriasis Patients
- ClinicalTrials.gov ID
- NCT04709354
- Acronym / sponsor ID
- 54022451-050.06.06
- Conditions
- Psoriasis Circinata, Psoriatic Arthritis, Rheumatoid Arthritis, Spondylarthropathies, Psoriatic Nail
- Keywords
- Psoriasis, Psoriatic Arthritis, Psoriatic Nail, Dermoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis patient | – | Diagnostic Test: Dermoscopic examinationSkin 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 | – | Diagnostic Test: Dermoscopic examinationSkin 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 | – | Diagnostic Test: Dermoscopic examinationSkin 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 | – | Diagnostic Test: Dermoscopic examinationSkin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years with psoriasis, rheumatoid arthritis, ankylosing spondylitis
Key inclusion criteria (2 listed)
- Psoriasis confirmed by dermatologist.
- Rheumatoid arthritis, ankylosing spondylitis confirmed by rheumatologist (newly diagnosed).
Key exclusion criteria (3 listed)
- Unable to consent and understand
- Patients with confirmed onychomycosis
- Patients receiving biological therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermoscopic examinationThe 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. | Diagnostic test | patients with spondylopathy, psoriasis patients without joint involvement, psoriatic arthritis, rheumatoid arthritis patient |
Primary outcome
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.
1 secondary outcome
Demographic characteristics
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Results publication: PubMed 28286468Yorulmaz 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.
- Results publication: PubMed 32055506Wanniang 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.
- Results publication: PubMed 29449498Zabotti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahide MD Onsun, Prof study director
Bezmialem University
Begüm MD Güneş principal investigator
Bezmialem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Circinata and Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparation of clinical features of nails (time frame: six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04709354, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.