- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092413
Subclinical Nail Involvement in Relevant Skin Diseases
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 .
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eman Riad, MDT
- Phone Number: 01005298992
- Email: e_riad@yahoo.com
Study Contact Backup
- Name: Yasmen Tawfeek, MDT
- Phone Number: 01006033331
- Email: dr.yasminmostawfik@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients complaining of common skin diseases ( psoriasis, atopic dermatitis, alopecia, lichen planus, and bullous diseases)
Exclusion Criteria:
- Patients who had gross visible nail changes will be excluded
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
almost 6 months after start of the research
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Tunc 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.
- Nakamura 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.
- Lencastre 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.
- Ronger 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.
- Grover 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.
- Jiaravuthisan 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNIRSD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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