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

Allergic Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991674
• Other study ID #: 131/2023
• Status: Recruiting
• Start date: June 30, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2023
• Source: Andreas Syggros Hospital of Venereal and Dermatological Diseases
• Contact: Aikaterini Kyritsi
• Phone: +30 2107274027
• Email: akyrits[@]pharm.uoa.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Diagnostic Test:
• patch test for diagnosing allergic contact dermatitis
European Baseline Series (EBS) System of allergens

Locations

Country	Name	City	State
Greece	Georgia Gogkla	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Andreas Syggros Hospital of Venereal and Dermatological Diseases

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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