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

NCT05991674 | Unknown

• 1 other identifier: 131/2023
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Contact Dermatitis

Keywords

Contact Sensitization; Patch Test; Machine Learning

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Allergic Contact Dermatitis Patients

Diagnostic Test: patch test for diagnosing allergic contact dermatitis

Interventions

patch test for diagnosing allergic contact dermatitis DIAGNOSTIC_TEST

European Baseline Series (EBS) System of allergens

Allergic Contact Dermatitis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Andreas Syggros Hospital of Venereal and Dermatological Diseases: lead

Study Sites (1)

Georgia Gogkla

Athens, Attica, 11621, Greece

RECRUITING

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Central Study Contacts

Aikaterini Kyritsi

CONTACT

+30 2107274027; akyrits@pharm.uoa.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Administrative Secretary

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 14, 2023
• Study Start: June 30, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

GR (1)