A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques

Sponsor

Andreas Syggros Hospital of Venereal and Dermatological Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT05991674

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to look into the patterns of sensitization to figure out how allergic contact dermatitis (ACD), individual susceptibility, and patient characteristics are connected. The joint application of classic statistics and machine learning methods will reveal the relationship between contact dermatitis expressions and several clinical characteristics.

Condition or Disease	Intervention/Treatment	Phase
Allergic Contact Dermatitis	Diagnostic Test: patch test for diagnosing allergic contact dermatitis

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques

Actual Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Allergic Contact Dermatitis Patients	Diagnostic Test: patch test for diagnosing allergic contact dermatitis European Baseline Series (EBS) System of allergens

Arm

Intervention/Treatment

Allergic Contact Dermatitis Patients

Diagnostic Test: patch test for diagnosing allergic contact dermatitis

European Baseline Series (EBS) System of allergens

Outcome Measures

Primary Outcome Measures

MOAHLFAP index [Clinical examination at baseline (0h)]
The MOAHLFAP index included characteristics of patients such as M (male), O (occupational dermatitis (OD)), A (atopic dermatitis (AD)), H (hand dermatitis (HD)), L (leg dermatitis (LD)), F (face dermatitis (FD)), A (age 40+), and P (at least one positive). Further on, we have used the criterion of trunk dermatitis (TD) and generalized dermatitis in our patients. This index contributes to the group description, stratifying the results as to the presence of sensitization prevalence and provides a multifunctional analysis in order to estimate the risk of sensitization (for example, being male with occupational contact dermatitis)
International Contact Dermatitis Research Group (ICDRG) scale [48 hours (Day 2) and 72 hours (Day 3) after the application of patch test]
According to the International Contact Dermatitis Research Group (ICDRG) guidelines, the skin reactions are assessed as positive/allergic in terms of intesity and morphology lesions on a scale of (i) weak +, (ii) strong ++, and (iii) extreme +++, while everything else as negative (including also the irritant reactions).This is assessed as the patch test result.
Antera 3D camera (Miravex, Dublin, Ireland) [0h (baseline), 48 hours (Day 2) and 72 hours (Day 3) after the application of patch test]
The skin condition is evaluated by the Antera 3D camera (Miravex, Dublin, Ireland) at baseline (0h), 48h and 72h after the first exposure to allergens. Antera 3D uses an innovative optical method and complex mathematical algorithms to acquire images in three dimensions. This makes it possible to extract data from images related to the three-dimensional shape of the skin, which allows the monitoring of changes over time. Hemoglobin concentration, skin texture and elevation were assessed with Antera 3D software (Miravex, Dublin, Ireland). The indications were recorded in arbitrary units.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Eligible patients were adults diagnosed with dermatitis who had a positive patch test result on the chemical panel of Baseline Series of Allergens.

Exclusion Criteria:

Although there is no consensus for the definitive exclusion criteria from a patch testing, most studies agree that the chronic use of anti-inflammatory treatments, corticosteroids, and cyclosporine, high UV exposure and other chronic dermatoses are factors that might produce false- positive or false- negative results and thus should be avoided.