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

Recruiting

• Conditions: Allergic Contact Dermatitis
• Interventions: Diagnostic Test: patch test for diagnosing allergic contact dermatitis

• Registration Number: NCT05991674
• Lead Sponsor: Andreas Syggros Hospital of Venereal and Dermatological Diseases

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-30
• Study First Submitted: 2023-07-27
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allergic Contact Dermatitis Patients	patch test for diagnosing allergic contact dermatitis	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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)

Trial Locations

Locations (1)

Georgia Gogkla; 🇬🇷 Athens, Attica, Greece