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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04092413
Other study ID # SNIRSD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 1, 2020

Study information

Verified date September 2019
Source Assiut University
Contact Eman Riad, MDT
Phone 01005298992
Email e_riad@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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 .


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 384
Est. completion date December 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Dermoscope
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 .

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

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. Review. — View Citation

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. Review. — View Citation

Lencastre A, Lamas A, Sá D, Tosti A. Onychoscopy. Clin Dermatol. 2013 Sep-Oct;31(5):587-93. doi: 10.1016/j.clindermatol.2013.06.016. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 almost 6 months after start of the research
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