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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Contact Dermatitis
• Intervention / Treatment: Diagnostic test: patch test for diagnosing allergic contact dermatitis

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Aikaterini Kyritsi; Phone Number: +30 2107274027; Email: akyrits@pharm.uoa.gr

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11621
      • Recruiting
      • Georgia Gogkla
      • Contact: Georgia Gogkla; Phone Number: +30 210 7210839; Email: grgkokla@yahoo.gr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patch test findings from 80 ACD patients will be gathered at the National Reference Center for Occupational Dermatoses "Andreas Syggros" Hospital's Laboratory for Patch Testing.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MOAHLFAP index	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)	Clinical examination at baseline (0h)
International Contact Dermatitis Research Group (ICDRG) scale	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.	48 hours (Day 2) and 72 hours (Day 3) after the application of patch test
Antera 3D camera (Miravex, Dublin, Ireland)	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.	0h (baseline), 48 hours (Day 2) and 72 hours (Day 3) after the application of patch test

Collaborators and Investigators

• Sponsor: Andreas Syggros Hospital of Venereal and Dermatological Diseases

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Patch Test; Machine Learning; Contact Sensitization
• 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: 131/2023

Drug and device information, study documents

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