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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05991674
Other study ID # 131/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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