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Dermoscopy in Diagnosis of Pigmentary Skin Lesions

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ClinicalTrials.gov Identifier: NCT03542539
Recruitment Status : Unknown
Verified May 2018 by Mohamed Sobeith, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Sobeith, Assiut University

Tracking Information
First Submitted Date March 26, 2018
First Posted Date May 31, 2018
Last Update Posted Date May 31, 2018
Estimated Study Start Date August 1, 2018
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2018)
The percentage of patients with pigmentary lesions [ Time Frame: 24 hours ]
use of dermoscope for diagnosis
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dermoscopy in Diagnosis of Pigmentary Skin Lesions
Official Title The Role of Dermoscopy in Diagnosis of Pigmentary Skin Lesions
Brief Summary Dermoscopy is a non-invasive method that allows evaluation of colors and microstructures of the epidermis, the dermoepidermal junction, and the papillary dermis not visible to the naked eye. These structures are specifically correlated to histologic features. The identification of specific diagnostic patterns related to the distribution of colors and dermoscopy structures can better suggest a malignant or benign pigmented skin lesion. The use of this technique provides a valuable aid in diagnosing pigmented skin lesions
Detailed Description

Skin color affected by many agents as it is determined by several chromophores such as melanin, hemoglobin and carotenoids. Among these, melanin is the main one responsible for different skin colors.

Melanin is produced by special skin cells called melanocytes and packed in organelles called melanosomes. Sometimes, human skin may present a non-uniform melanin distribution in two different ways, leading to pigmentary disorders.

In the first, melanin concentration increases to levels above normal resulting in hypermelanosis. In the second, the melanin concentration decreases to levels below normal, resulting in hypomelanosis.melanogenesis is acomplex process when disturbed ,it results into various pigmentary disorders either hypo or hyper pigmentation.

These disorders may be congenital or acquired, permenant or temporary, systemic or region restricted).

Pigmentary disorders are include alarge number of heterogenous conditions that are usually characterized by altered melanocyte density, melanin concentration, or both, and result in altered pigmentation of the skin. Some of these disorders are extremely common such as (melisma and vitiligo), whereas others are rare

Differential Diagnosis of Hyper and Hypopigmentation:

Hyperpigmentation Hypopigmentation Postinflammatory hyperpigmentation (acne, psoriasis, atopic and contact dermatitis, lichen planus, trauma, drugs, and fixed-drug eruptions) Melasma Solar lentigines Ephelides (freckles) Café-au-lait macules Nevi Melanoma and precursors Acquired (common) Vitiligo Pityriasis alba Tinea versicolor Postinflammatory hypopigmentation Congenital (uncommon) Albinism Piebaldism Tuberous sclerosis Hypomelanosis of Ito

Several studies have shown that dermoscopy may come in very handy for assisting the noninvasive diagnosis of various general dermatological disorders, including scalp/hair diseases (trichoscopy) , nail/nailfold abnormalities (onychoscopy) , cutaneous infections/infestations (entomodermoscopy) and inflammatory dermatoses (inflammoscopy) .

Dermoscopy is a non-invasive method that allows evaluation of colors and microstructures of the epidermis, the dermoepidermal junction, and the papillary dermis not visible to the naked eye. These structures are specifically correlated to histologic features. The identification of specific diagnostic patterns related to the distribution of colors and dermoscopy structures can better suggest a malignant or benign pigmented skin lesion. The use of this technique provides a valuable aid in diagnosing pigmented skin lesions, This traditionally consists of a magnifier , a non-polarised light source, a transparent plate and a liquid medium between the instrument and the skin .

The increasing use of dermoscopy in general dermatology can be partially explained by commercially available new generations of handheld dermoscopes, which are small enough to be easily placed in every dermatologist's pocket . It is a safe and rapid diagnostic tool that assists in clinical examination and management decision in dermatology

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population all patients attending assiut university hospital clinics complaining of pigmentary skin lesions
Condition
  • Pigmentary Skin Lesions
  • Dermoscopy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 20, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2019
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all patients attending assuit university hospital clinics complaining of pigmentary skin lesions

Exclusion Criteria:

  • no exclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03542539
Other Study ID Numbers RODIPSL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mohamed Sobeith, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date May 2018