Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool (PatchCam)

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®.

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Contact Dermatitis
• Intervention / Treatment: Other: The patch under study is photographed using 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Audrey NOSBAUM, MD; Phone Number: +33 418861572; Email: audrey.nosbaum@chu-lyon.fr
• Study Contact Backup: Name: Florence HACARD, MD; Phone Number: +33 4 78 86 15 72; Email: florence.hacard@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Photographs; Patch Test; Allergic contact dermatis (ACD); SkinCams
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
• Other Study ID Numbers: 69HCL22_0489

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No