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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05991674
Enrollment
80
Registered
2023-08-14
Start date
2023-06-30
Completion date
2023-10-30
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Contact Dermatitis

Keywords

Contact Sensitization, Patch Test, Machine Learning

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.

Interventions

DIAGNOSTIC_TESTpatch test for diagnosing allergic contact dermatitis

European Baseline Series (EBS) System of allergens

Sponsors

Andreas Syggros Hospital of Venereal and Dermatological Diseases
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MOAHLFAP indexClinical 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) scale48 hours (Day 2) and 72 hours (Day 3) after the application of patch testAccording 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 testThe 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.

Countries

Greece

Contacts

Primary ContactAikaterini Kyritsi
akyrits@pharm.uoa.gr+30 2107274027

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026