Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01194947

Enrollment

Registered

2010-09-03

Start date

2010-09-30

Completion date

2013-09-30

Last updated

2010-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Melanocytic Nevi

Keywords

banal-appearing nevi, NEVUS

Brief summary

Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.

Interventions

DEVICERCM imaging

RCM imaging will be performed using a commercially-available RCM (Vivascope 1500, Lucid Inc, Rochester, NY, USA) with 830-nm diode laser with emitting power less than 35 milliwatts

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients visiting the Sheba Medical Center pigmented lesion clinic for skin examination * Patients having at least three banal-appearing nevi, one on the upper back, one on the lower back and one on the lower extremity (excluding foot), which are amenable for RCM examination.

Exclusion criteria

* Patients who are unwilling or medically unable to lie down for 30 minutes. * Pregnant women

Design outcomes

Primary

Measure	Time frame
Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images).	3 YEARS

Secondary

Measure	Time frame
Description of rates of retention and change in RCM pattern of nevi during follow-up	3 YEARS

Countries

Israel

Contacts

Primary ContactALON SCOPE, MD

scopea1@gmail.com972-3-5302443

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026