Allergic Contact DermatitisPatchCamNCT06351449
Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool
An observational study of Allergic Contact Dermatitis, run by Hospices Civils de Lyon.
Trial summary
Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- The patch under study is photographed using the SkinCam®
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for suspected contact dermatitis to the Allergology and Clinical Immunology Department of the Centre Hospitalier Lyon Sud and the Dermatology and Allergology Department of the Centre Hospitalier Universitaire de St Etienne, with allergic contact dermatitis history and requiring patch test during their care pathway
Who may be able to join
- Patient, male or female, over 18 years of age
- Patients called for reading patch test, applied 72 or 96 hours ago
- Patients agreeing to have unidentified photographs of patchs tests
- Patient affiliated to or benefiting from a social security regime
- Patient having been informed and not having opposed
Who cannot join
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant woman
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.
The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.
Read more
Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.
This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®.
Read the detailed description
Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.
Allergic contact dermatitis (ACD) typically presents as a severe skin inflammation with redness, edema, oozing and crusting. It is characterized by a delayed type IV hypersensitivity response mediated by allergen-specific T cells in sensitized individuals. Current diagnosis relies on clinical investigations by diagnostic patch testing with suspected allergenic chemicals.
The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.
Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.
This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®.
- Conditions
- Allergic Contact Dermatitis
- Being tested
- The patch under study is photographed using the SkinCam®
- Keywords
- Allergic contact dermatis (ACD), Patch Test, Photographs, SkinCams
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patch under study is photographed using the SkinCam®Other
Unlike standard care, the patch under study is photographed using the SkinCam® and not a standard camera. The shooting and photographic remain similar to that of standard care, with only the camera used being changed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with allergic contact dermatitis history | Adult patients with allergic contact dermatitis history and requiring patch test during their care pathway and accepting unidentified photographs of patch test results. Receives: Other: The patch under study is photographed using the SkinCam® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To highlight characteristics of allergic contact dermatitis (ACD)
To highlight characteristics of allergic contact dermatitis (ACD), illustrating visually positive patch tests (+, ++, +++) with numerical parameters (colorimetry, shine and roughness)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact DermatitisStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
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
- NCT06351449
- Sponsor's protocol ID
- 69HCL22_0489
- Acronym
- PatchCam
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool
- ClinicalTrials.gov ID
- NCT06351449
- Acronym / sponsor ID
- PatchCam / 69HCL22_0489
- Conditions
- Allergic Contact Dermatitis
- Keywords
- Allergic contact dermatis (ACD), Patch Test, Photographs, SkinCams
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 8 Apr 2024 (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.
Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.
The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.
Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.
This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®.
Detailed description
Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.
Allergic contact dermatitis (ACD) typically presents as a severe skin inflammation with redness, edema, oozing and crusting. It is characterized by a delayed type IV hypersensitivity response mediated by allergen-specific T cells in sensitized individuals. Current diagnosis relies on clinical investigations by diagnostic patch testing with suspected allergenic chemicals.
The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.
Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.
This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with allergic contact dermatitis history | – | Other: The patch under study is photographed using the SkinCam®Adult patients with allergic contact dermatitis history and requiring patch test during their care pathway and accepting unidentified photographs of patch test results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for suspected contact dermatitis to the Allergology and Clinical Immunology Department of the Centre Hospitalier Lyon Sud and the Dermatology and Allergology Department of the Centre Hospitalier Universitaire de St Etienne, with allergic contact dermatitis history and requiring patch test during their care pathway
Key inclusion criteria (5 listed)
- Patient, male or female, over 18 years of age
- Patients called for reading patch test, applied 72 or 96 hours ago
- Patients agreeing to have unidentified photographs of patchs tests
- Patient affiliated to or benefiting from a social security regime
- Patient having been informed and not having opposed
Key exclusion criteria (2 listed)
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The patch under study is photographed using the SkinCam®Unlike standard care, the patch under study is photographed using the SkinCam® and not a standard camera. The shooting and photographic remain similar to that of standard care, with only the camera used being changed. | Other | Patients with allergic contact dermatitis history |
Primary outcome
To highlight characteristics of allergic contact dermatitis (ACD)
Time frame: one day
To highlight characteristics of allergic contact dermatitis (ACD), illustrating visually positive patch tests (+, ++, +++) with numerical parameters (colorimetry, shine and roughness)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Contact Dermatitis, run by Hospices Civils de Lyon.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey NOSBAUM, MD (418861572 ext. +33, audrey.nosbaum@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To highlight characteristics of allergic contact dermatitis (ACD) (time frame: one day). 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 8 Apr 2024.