Inflammatory Skin Disease, Psoriasiform Dermatoses, Eczematiform Dermatoses, Lichenoid Dermatoses, Psoriasis, Eczema, Lichen, Lupus, DermatomyositisODINNCT06874712
Interest of LC-OCT for Diagnosing Inflammatory Dermatoses: ODIN (OCT Dermotoses INflammatoires)
An observational study of Inflammatory Skin Disease, Psoriasiform Dermatoses, Eczematiform Dermatoses, Lichenoid Dermatoses, Psoriasis, Eczema, Lichen, Lupus, Dermatomyositis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Skin Disease, Psoriasiform Dermatoses, Eczematiform Dermatoses, Lichenoid Dermatoses, Psoriasis, Eczema, Lichen, Lupus, Dermatomyositis
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with a definitive histopathological diagnosis of inflammatory dermatosis with a classification by type (eczematiform, psoriasiform or lichenoid)
Who may be able to join
- - 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
- Medical subject headings
- Dermatitis, Psoriasis, Eczema, Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Definitive histopathological diagnosis of eczematiform dermatosis | Not described | |
| Psoriasiform dermatosis | Not described | |
| Lichenoid dermatosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe presence or absence of signs of inflammatory dermatoses found on LC-OCT images and on histological sections, in the same patient.
Measured: Baseline (day of realisation of the two examinations).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Jul 2022
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Skin Disease, Psoriasiform Dermatoses, Eczematiform Dermatoses, Lichenoid Dermatoses, Psoriasis, Eczema, Lichen, Lupus, DermatomyositisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874712
- Sponsor's protocol ID
- 24-5184
- Acronym
- ODIN
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of LC-OCT for Diagnosing Inflammatory Dermatoses: Comparison of Images Obtained with LC-OCT and Those from Histological Sections "ODIN (OCT Dermatoses INflamaatoires)
- ClinicalTrials.gov ID
- NCT06874712
- Acronym / sponsor ID
- ODIN / 24-5184
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Definitive histopathological diagnosis of eczematiform dermatosis | – | – |
| Psoriasiform dermatosis | – | – |
| Lichenoid dermatosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a definitive histopathological diagnosis of inflammatory dermatosis with a classification by type (eczematiform, psoriasiform or lichenoid)
Key inclusion criteria (3 listed)
- - 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Skin Disease, Psoriasiform Dermatoses, Eczematiform Dermatoses, Lichenoid Dermatoses, Psoriasis, Eczema, Lichen, Lupus, Dermatomyositis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.