- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06714799
Analysis of Videodermatoscopic Parameters of Ocular, Periocular, Conjunctival and Palpebral Neoformations
December 3, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
ANALYSIS OF VIDEODERMATOSCOPIC PARAMETERS OF OCULAR, PERIOCULAR, CONJUNCTIVAL AND PALPEBRAL NEOFORMATIONS
Study Overview
Status
Recruiting
Conditions
Detailed Description
The analysis of videodermatoscopic parameters of ocular, periocular, conjunctival and eyelid neoformations refers to the use of advanced technology that allows us to examine in detail the lesions or neoformations that appear in and around the eye areas.
Through videodermatoscopy, we can evaluate characteristics such as size, shape, color and internal structure of these neoformations, to distinguish benign ones from those that may require further diagnostic investigations or treatments.
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sabina Vaccari, MD
- Phone Number: 3403646960
- Email: sabina.vaccari@aosp.bo.it
Study Locations
-
-
-
Bologna, Italy, 40138
- Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
Contact:
- Sabina Vaccari SV Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients presented to the Videodermatoscopy Outpatient Clinic of the O.U.
Dermatology of the S. Orsola-Malpighi General Hospital
Description
Inclusion Criteria:
- patients who had been diagnosed with one of the following conditions in the ocular and periocular region: common melanocytic nevus, melanosis, seborrheic keratosis, viral wart, angioma and angiokeratoma, apocrine hydrocystoma, xanthelasma, steatocystoma, actinic keratosis, basal cell carcinoma, squamous cell carcinoma, melanoma.
Exclusion Criteria:
- Patients who presented with one of the following conditions were excluded from the study: concomitant inflammatory processes, including blepharitis, chalazion, pterygium, pinguecula), coexistence of multiple, periocular or ocular lesions, diagnosis of syndromic diseases related to a major risk for cutaneous neoformations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
features that could indicate their benign or malignant nature
Time Frame: from enrollment to the end of 2026
|
clinical and dermoscopic characteristics of periocular and ocular lesions
|
from enrollment to the end of 2026
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sabina Vaccari, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2021
Primary Completion (Estimated)
December 15, 2026
Study Completion (Estimated)
December 15, 2030
Study Registration Dates
First Submitted
November 28, 2024
First Submitted That Met QC Criteria
November 28, 2024
First Posted (Actual)
December 4, 2024
Study Record Updates
Last Update Posted (Estimated)
December 5, 2024
Last Update Submitted That Met QC Criteria
December 3, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DER-OCCHI-19-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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