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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06351449
Other study ID # 69HCL22_0489
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2024
Est. completion date April 30, 2027

Study information

Verified date April 2024
Source Hospices Civils de Lyon
Contact Audrey NOSBAUM, MD
Phone 418861572
Email audrey.nosbaum@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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®.


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 SkinCamĀ®, 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 SkinCamĀ®.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date April 30, 2027
Est. primary completion date April 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision - Pregnant woman

Study Design


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome

Type Measure Description Time frame Safety issue
Primary 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) one day
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