NCT06351449

Brief 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®.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Apr 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Apr 2024Apr 2027

First Submitted

Initial submission to the registry

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

3 years

First QC Date

April 2, 2024

Last Update Submit

April 2, 2024

Conditions

Keywords

Allergic contact dermatis (ACD)Patch TestPhotographsSkinCams

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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®

Interventions

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.

Patients with allergic contact dermatitis history

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System Diseases

Central Study Contacts

Audrey NOSBAUM, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 8, 2024

Study Start

April 15, 2024

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

April 8, 2024

Record last verified: 2024-04