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Dermatitis, Contact clinical trials

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NCT ID: NCT06331390 Recruiting - Contact Dermatitis Clinical Trials

Assessment of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis

Start date: April 2024
Phase: N/A
Study type: Interventional

Testing the effectiveness and safety of cosmetics with niacinamide in irritant contact dermatitis: A Randomised, Controlled Trial will be conducted at USSM. Healthy volunteers will be included (at least 25) and test sites are forearms. Sodium lauryl sulphate will be used to induce contact dermatitis and participants will be measured for 7 days

NCT ID: NCT06191627 Recruiting - Clinical trials for Allergic Contact Dermatitis

Patient Experience and Quality of Patch Testing on the Legs vs Back

Start date: March 4, 2024
Phase: N/A
Study type: Interventional

The gold standard for the diagnosis of allergic contact dermatitis is patch testing, during which allergens are affixed to the skin underneath tape and left for multiple days. A large area of clear skin is thus required for successful testing. While the back is traditionally thought to be the ideal area for testing, the thighs may be more available or advantageous. This study seeks to randomize patients undergoing patch testing to have patches placed on the back or the thighs. The investigators seek to understand the benefits of testing on the legs versus the back in terms of patient experience as well as achieving a successful test. This study will measure patient experience using a survey administered to patients. Quality of testing will be assessed by study coordinators prior the removal of patches.

NCT ID: NCT06189144 Recruiting - Contact Dermatitis Clinical Trials

Testing an Intervention in Irritative Contact Dermatitis

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.

NCT ID: NCT06177314 Recruiting - Contact Dermatitis Clinical Trials

Molecular Diagnosis of Allergic Contact Dermatitis

MODAL
Start date: April 1, 2023
Phase:
Study type: Observational

Allergic contact dermatitis (ACD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries. ACD typically presents as a severe skin inflammation with redness, edema, oozing and crusting. It is characterized by a delayed type IV hypersensitivity response mediated by allergen-specific T cells in sensitized individuals. Current diagnosis relies on clinical investigations by diagnostic patch testing with suspected allergenic chemicals. The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. This is a time consuming and costly process. It requires experienced medical staff to read the reaction, and is only performed by a limited number of expert dermato-allergologists across Europe (which limits the accessibility of suspected ACD patients to diagnosis). Finally, if the robustness of the patch-test method is undisputable, it cannot be neglected that patch-test results are sometimes false positive or non-relevant, which leads to non-appropriate disease management. Therefore, there is today an urgent need for the availability of new ex vivo/in vitro tools based on the modern understanding of the immune mechanisms of ACD to enhance the current diagnostic procedure, and open new avenues for a personalized diagnosis of skin ACD. In this context, the team "Epidermal Immunity and Allergy" (CIRI, Inserm U1111) recently characterized the molecular signatures of ACD (using microarrays), based on positive patch-test reactions to reference chemical allergens or non-allergenic irritants. It was shown that there are unique molecular profiles and signaling pathways characterizing each inflammation. Machine learning methods were then developed to identify and validate classification algorithms based on the expression levels of a minimum set of biomarkers (n=12), enabling very good discrimination between allergen-induced and irritant-induced patch-test inflammation (which was confirmed by complementary quantitative RT-PCR analyses). Finally, some patients with weak positive patch-test reactions to allergens show no/low marks of allergy molecular signature, questioning about the reliability/relevance of their patch-tests results. Our results therefore stress the value of molecular profiling of patch-test reactions to improve/reinforce clinical ACD diagnosis, and to help the dermatologist to discriminate true versus false positive patch test reactions. Importantly, those results also open new avenues for the development of a future point care diagnosis. Indeed, it is currently is estimated that only 20% of patients being sent for allergology work-ups suffer from true skin allergy (i.e. patients with positive patch-tests, combined with relevant clinical history and confirmatory use tests). Most of the patients (80%) are in fact suffering from skin irritation. Therefore, the detection of ACD biomarkers in active eczema lesions could provide the dermatologist with major information to improve and accelerate its clinical diagnosis. This could also prevent numerous patients (negative for ACD biomarkers) being sent for unnecessary allergology work-ups. However, to date, it remains to be demonstrated that (i) the same panel of ACD biomarkers is expressed both in acute eczema lesions and positive patch-test reactions, and that (ii) the detection of these biomarkers allows for a sensitive and reliable diagnosis of skin allergy. The main objective of the study will be to make the proof of concept that the expression of allergy biomarkers correlates with patients suffering from true ACD (i.e. patients with high biomarker expression in acute lesions, positive patch-tests and relevant clinical history), versus those developing skin irritation (no/low biomarker expression in acute lesions, negative patch-tests, and lack of clinical history).

NCT ID: NCT06124781 Recruiting - Eczema Clinical Trials

Molecular Diagnosis of Allergic Contact Dermatitis (SMECA).

SMECA
Start date: June 20, 2023
Phase: N/A
Study type: Interventional

Allergic contact dermatitis (ACD) is a common inflammatory skin disease, which represents a major public health issue in industrialized countries. ACD is induced by repeated contact of individuals with environmental chemicals and is characterized by a delayed type IV hypersensitivity response with skin inflammation mediated by allergen-specific T cells in sensitized individuals. The current diagnosis is based on clinical examination, assessment of environmental exposures and patch testing. Although the robustness of patch tests has long been established, this method can sometimes give inconclusive results, leading to problems in disease management. Preliminary results indicate that the molecular analysis of Patch-Tests (PT) reactions could allow a more reliable diagnosis. Importantly, this gene profiling approach may help to identify patients with false positive PT reactions, i.e. patients whose PT reactions did not show any "allergy signature". However, it remains to be demonstrated that the presence or absence of allergy biomarkers in PT lesions are indeed predictive of ACD response in patients. The main objective is to describe the correlation between these molecular signatures and the reactivity of individuals when they are exposed to allergenic compounds under conditions of use (using ROAT test).

NCT ID: NCT05991674 Recruiting - Clinical trials for Allergic Contact Dermatitis

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

Start date: June 30, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05858723 Not yet recruiting - Clinical trials for Allergic Contact Dermatitis

Repeated Open Application Test (ROAT) Study With Hydroperoxides of Linalool

Start date: August 2023
Phase: N/A
Study type: Interventional

Linalool is currently one of the most used fragrance substances in cosmetic and household products. Previous studies report a high prevalence (5.9-11.7%) of contact allergy to hydroperoxides of linalool (Lin-OOH)1.0% in pet. among patch tested patients. The optimal test concentration of Lin-OOH in patch tests is not known and requires further investigation. It is of great importance to establish the optimal test concentration and elicitation threshold of Lin-OOH to improve diagnosis and prevent development of Allergic Contact Dermatitis (ACD). We want to mimic real-life exposure to Lin-OOH, by conducting a ROAT (Repeated Open Application Test) study, on 40 adult participants (20 patients with confirmed contact allergy to Lin-OOH, and 20 healthy participants) to low doses of Lin-OOH using a simulated "perfume", during a maximum of 21 days of exposure. With this knowledge, we aim to: 1. Establish the optimal patch test concentration to diagnose ACD to Lin-OOH 2. In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product

NCT ID: NCT05535738 Recruiting - Clinical trials for Allergic Contact Dermatitis

Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Start date: November 15, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to answer: how do inflammation and anti-inflammatory skin therapies work in the skin? Inflammation is a protective response from the body's immune system to injury, disease, or irritation. It is a process by which your body's white blood cells and the things they make protect you from infection from outside invaders such as bacteria and viruses.

NCT ID: NCT05508243 Completed - Clinical trials for Sensitivity, Contact

Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization of Hyaluronic Nasal Spray

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability and Dermal Sensitization, of health products through the application of Patch Test, proving the safety of the product for topical use. The study will be conducted with a Brazilian sample in which 65 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested.

NCT ID: NCT05508230 Completed - Clinical trials for Sensitivity, Contact

Evaluation of Cutaneous Acceptability and Perceived Effectiveness of a Nasal Spray (Health Care Products)

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

This is a clinical study for health care product safety assessment. The research is going to conducted with 45 subjects, aged 18 to 70 years, women users of the product category, regardless of color/race, ethnicity, sexual orientation, classes and social groups and who must present all the other characteristics of the inclusion criteria and no exclusion characteristics. The product is applied under real conditions of use, in a panel of survey participants corresponding to the target consumers. Medical evaluation will be available throughout the study to assess possible adverse events. The main of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy and perceived acceptability.