Nail DiseasesNCT04092413
Subclinical Nail Involvement in Relevant Skin Diseases
An observational study of Nail Diseases, run by Assiut University.
Trial summary
Onychopathies constitute one of the major challenges faced by a dermatologist in terms of its early detection and diagnosis . Many disorders can affect the nails, including deformity and dystrophy, infections, and ingrown toenails. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nail Diseases
- What is being tested?
- Dermoscope
- Type of treatment
- Medical device
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients attending the Dermatology clinic , Assiut University Hospitals, Assiut, Egypt, during a period of one year complaining of ( psoriasis,PRP, lichen planus, atopic dermatitis and auto immune bullous diseases) will be recruited in the study
Who may be able to join
- Patients complaining of common skin diseases ( psoriasis, atopic dermatitis, alopecia, lichen planus, and bullous diseases)
Who cannot join
- Patients who had gross visible nail changes will be excluded
Trial locations and contacts
No sites are listed yet.
About this study
Onychopathies constitute one of the major challenges faced by a dermatologist in terms of its early detection and diagnosis .
Many disorders can affect the nails, including deformity and dystrophy, infections, and ingrown toenails. Infections can involve any part of the nail and may or may not change the nail's appearance. Most nail infections are fungal (onychomycosis), but bacterial and viral infections occur .
Read the detailed description
Nails are characteristically affected in skin diseases such as psoriasis (speckling, psoriatic oil spot, crumbling nails, pachyonychia) ,lichen( anonychia, dystrophy) ,alopecia areata (speckling, trachyonychia, longitudinal grooves, leukonychia), atopic dermatitis (shiny nails, transverse grooves, speckling, paronychia) and other diseases.
Nail disorders are assessed by clinical inspection, dermatoscopy , microbiological (including mycological) testing, and histopathological examination by nail biopsy .
Utility of dermoscope as a tool for detection is increasing by the day and its use in onychopathies needs to be explored .
Nail dermoscopy has initially been used for the assessment of nail pigmentation . But its utilization has expanded for the diagnosis of all nail disorders; it became a routine diagnostic instrument, as its reveals helpful information. Dermoscopy can be applied to all visible parts of the nail unit, and even the nail matrix can be studied, in conjunction with intraoperative methods .
Nail dermoscopy offers many advantages. Mostly, it enhances visible nail features; however, it can also help identify additional unique and fascinating features, not visible to the naked eye. It is practical, noninvasive and still opens up a second microscopic level of inspection. It contributes toward confirmation of diagnosis and assessment of treatment response as well as prognosis.
In a cross-sectional study to detect signs of subclinical nail involvement in 68 patients with chronic plaque psoriasis, Forty-six patients showed nail dermoscopic findings. Coarse pits, onycholysis, oil drop sign and splinter hemorrhages were seen .
To the best of the investigator's knowledge, no available studies in the literature evaluate subclinical nail affection in skin diseases as lichen planus, atopic dermatitis and auto immune bullous diseases. Hence, with the help of a dermoscope,early diagnosis and appropriate treatment can be instituted.
- Conditions
- Nail Diseases
- Being tested
- Dermoscope
- Medical subject headings
- Nail Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermoscopeDevice
It is a non invasive tool that permits the visualization of morphological features that are not visible to the naked eye thus representing a link between macroscopic dermatopathology .
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subclinical nail involvement in relevant skin diseases
dermoscopic examination of the nails searching for subclinical nail manifestations of some skin diseases like psoriasis , atopy , lichen , bullous diseases and alopecia areata
Measured: almost 6 months after start of the research
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nail DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YSAbdelraheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092413
- Sponsor's protocol ID
- SNIRSD
- Status last verified
- Sep 2019
- First submitted
- 14 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yadav TA, Khopkar US. Dermoscopy to Detect Signs of Subclinical Nail Involvement in Chronic Plaque Psoriasis: A Study of 68 Patients. Indian J Dermatol. 2015 May-Jun;60(3):272-5. doi: 10.4103/0019-5154.156377.
PubMed 26120154Tunc SE, Ertam I, Pirildar T, Turk T, Ozturk M, Doganavsargil E. Nail changes in connective tissue diseases: do nail changes provide clues for the diagnosis? J Eur Acad Dermatol Venereol. 2007 Apr;21(4):497-503. doi: 10.1111/j.1468-3083.2006.02012.x.
PubMed 17373977Nakamura RC, Costa MC. Dermatoscopic findings in the most frequent onychopathies: descriptive analysis of 500 cases. Int J Dermatol. 2012 Apr;51(4):483-5. doi: 10.1111/j.1365-4632.2010.04720.x. No abstract available.
PubMed 22435443Lencastre A, Lamas A, Sa D, Tosti A. Onychoscopy. Clin Dermatol. 2013 Sep-Oct;31(5):587-93. doi: 10.1016/j.clindermatol.2013.06.016.
PubMed 24079588Ronger S, Touzet S, Ligeron C, Balme B, Viallard AM, Barrut D, Colin C, Thomas L. Dermoscopic examination of nail pigmentation. Arch Dermatol. 2002 Oct;138(10):1327-33. doi: 10.1001/archderm.138.10.1327.
PubMed 12374538Grover C, Jakhar D. Onychoscopy: A practical guide. Indian J Dermatol Venereol Leprol. 2017 Sep-Oct;83(5):536-549. doi: 10.4103/ijdvl.IJDVL_242_16.
PubMed 28485306Jiaravuthisan MM, Sasseville D, Vender RB, Murphy F, Muhn CY. Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy. J Am Acad Dermatol. 2007 Jul;57(1):1-27. doi: 10.1016/j.jaad.2005.07.073.
PubMed 17572277
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Nail Involvement in Relevant Skin Diseases
- ClinicalTrials.gov ID
- NCT04092413
- Acronym / sponsor ID
- SNIRSD
- Conditions
- Nail Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 17 Sep 2019 (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.
Onychopathies constitute one of the major challenges faced by a dermatologist in terms of its early detection and diagnosis .
Many disorders can affect the nails, including deformity and dystrophy, infections, and ingrown toenails. Infections can involve any part of the nail and may or may not change the nail's appearance. Most nail infections are fungal (onychomycosis), but bacterial and viral infections occur .
Detailed description
Nails are characteristically affected in skin diseases such as psoriasis (speckling, psoriatic oil spot, crumbling nails, pachyonychia) ,lichen( anonychia, dystrophy) ,alopecia areata (speckling, trachyonychia, longitudinal grooves, leukonychia), atopic dermatitis (shiny nails, transverse grooves, speckling, paronychia) and other diseases.
Nail disorders are assessed by clinical inspection, dermatoscopy , microbiological (including mycological) testing, and histopathological examination by nail biopsy .
Utility of dermoscope as a tool for detection is increasing by the day and its use in onychopathies needs to be explored .
Nail dermoscopy has initially been used for the assessment of nail pigmentation . But its utilization has expanded for the diagnosis of all nail disorders; it became a routine diagnostic instrument, as its reveals helpful information. Dermoscopy can be applied to all visible parts of the nail unit, and even the nail matrix can be studied, in conjunction with intraoperative methods .
Nail dermoscopy offers many advantages. Mostly, it enhances visible nail features; however, it can also help identify additional unique and fascinating features, not visible to the naked eye. It is practical, noninvasive and still opens up a second microscopic level of inspection. It contributes toward confirmation of diagnosis and assessment of treatment response as well as prognosis.
In a cross-sectional study to detect signs of subclinical nail involvement in 68 patients with chronic plaque psoriasis, Forty-six patients showed nail dermoscopic findings. Coarse pits, onycholysis, oil drop sign and splinter hemorrhages were seen .
To the best of the investigator's knowledge, no available studies in the literature evaluate subclinical nail affection in skin diseases as lichen planus, atopic dermatitis and auto immune bullous diseases. Hence, with the help of a dermoscope,early diagnosis and appropriate treatment can be instituted.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients attending the Dermatology clinic , Assiut University Hospitals, Assiut, Egypt, during a period of one year complaining of ( psoriasis,PRP, lichen planus, atopic dermatitis and auto immune bullous diseases) will be recruited in the study
Key inclusion criteria (1 listed)
- Patients complaining of common skin diseases ( psoriasis, atopic dermatitis, alopecia, lichen planus, and bullous diseases)
Key exclusion criteria (1 listed)
- Patients who had gross visible nail changes will be excluded
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 |
|---|---|---|
| DermoscopeIt is a non invasive tool that permits the visualization of morphological features that are not visible to the naked eye thus representing a link between macroscopic dermatopathology . | Device | – |
Primary outcome
Percentage of subclinical nail involvement in relevant skin diseases
Time frame: almost 6 months after start of the research
dermoscopic examination of the nails searching for subclinical nail manifestations of some skin diseases like psoriasis , atopy , lichen , bullous diseases and alopecia areata
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Background: PubMed 26120154Yadav TA, Khopkar US. Dermoscopy to Detect Signs of Subclinical Nail Involvement in Chronic Plaque Psoriasis: A Study of 68 Patients. Indian J Dermatol. 2015 May-Jun;60(3):272-5. doi: 10.4103/0019-5154.156377.
- Background: PubMed 17373977Tunc SE, Ertam I, Pirildar T, Turk T, Ozturk M, Doganavsargil E. Nail changes in connective tissue diseases: do nail changes provide clues for the diagnosis? J Eur Acad Dermatol Venereol. 2007 Apr;21(4):497-503. doi: 10.1111/j.1468-3083.2006.02012.x.
- Background: PubMed 22435443Nakamura RC, Costa MC. Dermatoscopic findings in the most frequent onychopathies: descriptive analysis of 500 cases. Int J Dermatol. 2012 Apr;51(4):483-5. doi: 10.1111/j.1365-4632.2010.04720.x. No abstract available.
- Background: PubMed 24079588Lencastre A, Lamas A, Sa D, Tosti A. Onychoscopy. Clin Dermatol. 2013 Sep-Oct;31(5):587-93. doi: 10.1016/j.clindermatol.2013.06.016.
- Background: PubMed 12374538Ronger S, Touzet S, Ligeron C, Balme B, Viallard AM, Barrut D, Colin C, Thomas L. Dermoscopic examination of nail pigmentation. Arch Dermatol. 2002 Oct;138(10):1327-33. doi: 10.1001/archderm.138.10.1327.
- Background: PubMed 28485306Grover C, Jakhar D. Onychoscopy: A practical guide. Indian J Dermatol Venereol Leprol. 2017 Sep-Oct;83(5):536-549. doi: 10.4103/ijdvl.IJDVL_242_16.
- Background: PubMed 17572277Jiaravuthisan MM, Sasseville D, Vender RB, Murphy F, Muhn CY. Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy. J Am Acad Dermatol. 2007 Jul;57(1):1-27. doi: 10.1016/j.jaad.2005.07.073.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Nail Diseases, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Riad, MDT (01005298992, e_riad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subclinical nail involvement in relevant skin diseases (time frame: almost 6 months after start of the research). 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 NCT04092413, which also lists 7 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 17 Sep 2019.