Molecular diagnosis for allergic contact dermatitis

The Value of Molecular Signatures in the Diagnosis of Allergic Contact Dermatitis.

This study is testing a new way to diagnose allergic contact dermatitis by looking at blood and skin samples to see if it can help find out who really has the condition and who doesn't.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ramsay Générale de Santé (other)
• Locations: 5 sites (Bruxelles and 4 other locations)
• Trial ID: NCT06124781 on ClinicalTrials.gov

What this trial studies

This study aims to improve the diagnosis of allergic contact dermatitis (ACD) by utilizing molecular analysis of patch test reactions. ACD is a common inflammatory skin condition caused by environmental chemicals, and current diagnostic methods can sometimes yield inconclusive results. By analyzing blood samples and skin biopsies, the study seeks to identify patients with false positive patch test reactions, thereby enhancing disease management. The approach focuses on gene profiling to provide a more reliable diagnosis for affected individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 with at least one positive or doubtful patch test reaction to specific allergens.

Not a fit: Patients with active dermatitis lesions on the forearm or those with certain medical histories may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses of allergic contact dermatitis, improving treatment outcomes for patients.

How similar studies have performed: Preliminary results from similar approaches suggest potential for success, but this specific methodology remains to be fully validated.

Eligibility criteria

Inclusion Criteria:

* Patient, male or female, over 18 years of age.
* Patient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide
* Patient agreeing to undergo skin biopsies and blood sampling
* Patient agreeing to non-identifying pictures being taken of lesions
* Patient available to carry out skin tests and their interpretation
* Patient affiliated to or benefiting from a social security regime
* Patient having been informed and having signed a written, free and informed consent.

Exclusion Criteria:

* Patient with active dermatitis lesions on the forearm
* Patient with a history of allergic reaction to a local anesthetic product
* Patient with wound healing disorders (hypertrophic or keloids scars)
* Patient with hematological disorders
* Patient having topical treatments with corticosteroids or immunomodulators on the forearms during the 21 days prior to the start of the study
* Patient having had excessive exposure to ultraviolet during the 21 days prior to the start of the study.
* Patient on systemic corticosteroid therapy, immunosuppressants or biological therapy.
* Patient whose follow-up is impossible for reasons psychological or geographical.
* Patient taking part in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breast-feeding or parturient woman

Where this trial is running

Bruxelles and 4 other locations

• Clinique universitaire Saint Luc — Bruxelles, Belgium (RECRUITING)
• CHU de Grenoble — La Tronche, France (RECRUITING)
• CHU Lyon Sud — Pierre-Bénite, France (RECRUITING)
• CHU de Saint Etienne — Saint-Priest-en-Jarez, France (RECRUITING)
• Hopital Privé de la Loire — Saint-Étienne, France (RECRUITING)

Study contacts

• Study coordinator: Jean-François Oudet

Conditions: Eczema, Allergic Contact Eczema Nos