Interest of LC-OCT for Diagnosing Inflammatory Dermatoses: ODIN (OCT Dermotoses INflammatoires) (ODIN)

March 7, 2025 updated by: Hospices Civils de Lyon

Interest of LC-OCT for Diagnosing Inflammatory Dermatoses: Comparison of Images Obtained with LC-OCT and Those from Histological Sections "ODIN (OCT Dermatoses INflamaatoires)

Inflammatory dermatoses (eczematiform dermatoses, psoriasiform dermatoses, lichenoid dermatoses, toxic dermatoses, auto-immune and auto-inflammatory dermatoses, etc.) and their differential diagnoses (infectious or para-infectious dermatoses, deficiency dermatoses, etc.) are frequent reasons for dermatology consultations. These dermatoses are clinically heterogeneous eruptions for which a skin biopsy for histological examination may be routinely required to confirm the diagnosis.

LC-OCT (DeepLive Damae Medical machine) is a new non-invasive skin imaging technique (using non-ionizing infrared light), enabling observation of skin tissue to a depth of 500 µm with a resolution of 1 µm (= "cellular" resolution, the keratinocyte, the main skin cell, measuring between 5 and 10 µm).

This technique has already proved its worth in the diagnosis of skin cancers, and has the advantage of being non-invasive, painless and quicker than a biopsy. The investigators of the study want to study its value in the diagnosis of inflammatory dermatoses.

During the consultation dedicated to skin biopsy, a cutaneous LC-OCT examination is routinely performed, but only for exploratory purposes, allowing better targeting of the most modified area. The aim of the study is to describe and analyze the characteristics of cutaneous imaging (LC-OCT) in inflammatory dermatoses, comparing them with the histological appearance of biopsy specimens.

This is a preliminary study aimed at defining the value of LC-OCT in the diagnosis of inflammatory dermatoses, in the hope of replacing skin biopsy in the future.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • France, France, 69347
        • Service de Dermatologie, HEH, HCL

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with a definitive histopathological diagnosis of inflammatory dermatosis with a classification by type (eczematiform, psoriasiform or lichenoid)

Description

Inclusion Criteria:

  • - Age greater than or equal to 18 years.
  • Definitive histopathological diagnosis of inflammatory dermatosis, including classification by type (eczematiform, psoriasiform or lichenoid) and subtype (e.g. atopic dermatitis for eczematiform dermatosis, lupus for lichenoid dermatosis, etc.).
  • Availability of good-quality LC-OCT images/videos, with at least one interpretable 3D block, a video scanning lesional and healthy skin in a manner deemed "sufficient", as judged collegially by the authors.

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Definitive histopathological diagnosis of eczematiform dermatosis
Psoriasiform dermatosis
Lichenoid dermatosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Describe presence or absence of signs of inflammatory dermatoses found on LC-OCT images and on histological sections, in the same patient.
Time Frame: Baseline (day of realisation of the two examinations).
Baseline (day of realisation of the two examinations).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

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)

July 1, 2022

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5184

Drug and device information, study documents

product manufactured in and exported from the U.S.

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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