Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes

Nevus, Pigmented Clinical Trial

Official title:

Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05463510
• Other study ID #: Karar no:108 25.03.2022
• Status: Completed
• Start date: March 25, 2022
• Est. completion date: April 25, 2022

Study information

• Verified date: July 2022
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Childhood and adolescence are a dynamic process in terms of nevogenesis, and the development and growth of new melanocytic nevus is frequently observed. Melanomas, although rare, can also be seen in the pediatric age group. Therefore, nevus monitoring with videodermoscopy may be necessary in the pediatric age group. Aim of our study is to show the dynamic pattern and diameter modifications in pediatric nevi.

Description:

Aim of our study is to show the dynamic pattern and diameter modifications in pediatric nevi. Patients who applied to the Dermatology Clinic of Istanbul Training and Research Hospital between January 2008 and January 2022, were diagnosed with pediatric melanocytic nevus clinically and dermoscopically were included. Patients who had records for at least twice with videodermoscopy every 3 months were included. In the study, 301 pediatric melanocytic nevi belonging to 50 patients were evaluated.

The following characteristics were recorded in a database specifically designed for the study:Demographic findings of the patients, nevus localization, nevus pattern (baseline and follow-up), nevus diameter (base line and follow-up at 3/12/36th months), histopathological results of nevi that underwent total excision were recorded. The change in nevus diameter during follow-up was measured in millimeters based on the longest axis. Presence of peripheral globules, outcome of peripheral globules, characteristics of peripheral globules were recorded. Characteristics of peripheral globules were evaluated according to being around the entire lesion (circumferential) versus focally presence, typical (uniform shape and colors) and being regular (single rim of globules or multiple rim of globules)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Subjects <18 years of age

• Subjects who have dermoscopic diagnosis of melanocytic nevus

• Subjects who had dermoscopic follow up for at least 3 months

Exclusion Criteria:

• Subjects >18 years of age

Related Conditions & MeSH terms

• Nevus
• Nevus, Pigmented

Intervention

Diagnostic Test:
• Videodermoscopy
Patients who had records for at least twice with videodermoscopy every 3 months were included.

Locations

Country	Name	City	State
Turkey	Istanbul Teaching and Research Hospital	Istanbul	Istanbul/Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Fortina AB, Zattra E, Bernardini B, Alaibac M, Peserico A. Dermoscopic changes in melanocytic naevi in children during digital follow-up. Acta Derm Venereol. 2012 Jul;92(4):427-9. doi: 10.2340/00015555-1306. — View Citation

Piazza CD, Yamada S, Marcassi AP, Maciel MG, Seize MP, Cestari SCP. Dermoscopic patterns of melanocytic nevi in children and adolescents: a cross-sectional study. An Bras Dermatol. 2017 May-Jun;92(3):340-344. doi: 10.1590/abd1806-4841.20175209. — View Citation

Zalaudek I, Schmid K, Marghoob AA, Scope A, Manzo M, Moscarella E, Malvehy J, Puig S, Pellacani G, Thomas L, Catricalà C, Argenziano G. Frequency of dermoscopic nevus subtypes by age and body site: a cross-sectional study. Arch Dermatol. 2011 Jun;147(6):6 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric nevi diameter change in millimeters	1.Nevus diameter change at 3/12/36th months (measurement of longest axis of nevus as millimeters with videodermoscopy)	3-36 months
Primary	Pediatric nevi pattern change	Nevus pattern change at 3/12/36th months (pattern is categorized as globular/reticular/homogenous/fibrillar/parallel furrow or combinations)	3-36 months
Primary	Presence of peripheral globules	Peripheral globules will be recorded if present and will be categorized as (increased, decreased or no change) at the 3/12/36th months	3-36 months