Allergic Contact DermatitisNCT05991674
A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques
An observational study of Allergic Contact Dermatitis, run by Andreas Syggros Hospital of Venereal and Dermatological Diseases at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- patch test for diagnosing allergic contact dermatitis
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jun 2023to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- -
- Eligible patients were adults diagnosed with dermatitis who had a positive patch test result on the chemical panel of Baseline Series of Allergens.
Who cannot join
- -
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Georgia Gogkla
Athens, Attica, 11621
Georgia Gogkla, +30 210 7210839, grgkokla@yahoo.gr
About this study
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
- Being tested
- patch test for diagnosing allergic contact dermatitis
- Keywords
- Contact Sensitization, Patch Test, Machine Learning
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patch test for diagnosing allergic contact dermatitisDiagnostic test
European Baseline Series (EBS) System of allergens
| Study group | Role | What they receive |
|---|---|---|
| Allergic Contact Dermatitis Patients | Not described Receives: Diagnostic Test: patch test for diagnosing allergic contact dermatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 0h (baseline), 48 hours (Day 2) and 72 hours (Day 3) after the application of patch test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Jun 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andreas Syggros Hospital of Venereal and Dermatological Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEORGIA KOKLA, Andreas Syggros Hospital of Venereal and Dermatological Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991674
- Sponsor's protocol ID
- 131/2023
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques
- ClinicalTrials.gov ID
- NCT05991674
- Acronym / sponsor ID
- 131/2023
- Conditions
- Allergic Contact Dermatitis
- Keywords
- Contact Sensitization, Patch Test, Machine Learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Andreas Syggros Hospital of Venereal and Dermatological DiseasesUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergic Contact Dermatitis Patients | – | Diagnostic Test: patch test for diagnosing allergic contact dermatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- -
- Eligible patients were adults diagnosed with dermatitis who had a positive patch test result on the chemical panel of Baseline Series of Allergens.
Key exclusion criteria (2 listed)
- -
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patch test for diagnosing allergic contact dermatitisEuropean Baseline Series (EBS) System of allergens | Diagnostic test | Allergic Contact Dermatitis Patients |
Primary outcome
MOAHLFAP index
Time frame: 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)
International Contact Dermatitis Research Group (ICDRG) scale
Time frame: 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.
Antera 3D camera (Miravex, Dublin, Ireland)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Contact Dermatitis, run by Andreas Syggros Hospital of Venereal and Dermatological Diseases at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aikaterini Kyritsi (+30 2107274027, akyrits@pharm.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOAHLFAP index (time frame: Clinical examination at baseline (0h)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.