- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05463510
Dermoscopic Monitoring of Pediatric Melanocytic Nevi Regarding Pattern and Diameter Changes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul/Fatih
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Istanbul, Istanbul/Fatih, Turkey, 34098
- Istanbul Teaching and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric melanocytic nevus
50 patients and 301 pediatric nevi were evaluated
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Patients who had records for at least twice with videodermoscopy every 3 months were included.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric nevi diameter change in millimeters
Time Frame: 3-36 months
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1.Nevus diameter change at 3/12/36th months (measurement of longest axis of nevus as millimeters with videodermoscopy)
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3-36 months
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Pediatric nevi pattern change
Time Frame: 3-36 months
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Nevus pattern change at 3/12/36th months (pattern is categorized as globular/reticular/homogenous/fibrillar/parallel furrow or combinations)
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3-36 months
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Presence of peripheral globules
Time Frame: 3-36 months
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Peripheral globules will be recorded if present and will be categorized as (increased, decreased or no change) at the 3/12/36th months
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3-36 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Ayse Esra Koku Aksu, MD, Istanbul Teaching and Research Hospital
Publications and helpful links
General Publications
- 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.
- Zalaudek I, Schmid K, Marghoob AA, Scope A, Manzo M, Moscarella E, Malvehy J, Puig S, Pellacani G, Thomas L, Catricala C, Argenziano G. Frequency of dermoscopic nevus subtypes by age and body site: a cross-sectional study. Arch Dermatol. 2011 Jun;147(6):663-70. doi: 10.1001/archdermatol.2011.149.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Karar no:108 25.03.2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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