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This study aims to identify subpopulations of patients with cholinergic urticaria based on their sensitivity to infrared (IR) radiation exposure. Cholinergic urticaria is a chronic inducible urticaria triggered by increased body temperature. The study seeks to determine whether infrared exposure can induce symptoms in a subset of patients and whether these patients exhibit specific clinical or epidemiological characteristics.
Cholinergic urticaria is characterized by small pruritic papules triggered by exercise, emotions, hot environments, or hot food and beverages. The pathophysiology remains unclear, but one hypothesis is that a central temperature increase plays a key role. A pilot study conducted at university hospital center (CHU) of Montpellier found that infrared exposure triggered symptoms in some patients with cholinergic urticaria. The infrared source was the same as that commonly used in photobiological tests.
The objective of this study is to identify the proportion of patients who develop cholinergic urticaria when exposed to infrared light. the investigators then aim to determine whether these patients have specific clinical or epidemiological characteristics that would allow them to be classified as a distinct subgroup of cholinergic urticaria and to assess whether sensitivity to infrared light is a prognostic marker of disease severity. Furthermore, measuring the core temperature of all patients during infrared light exposure will help determine whether patients sensitive to infrared light experience a greater increase in core temperature during the IR test. This would support the hypothesis that an increase in core temperature is responsible for triggering cholinergic urticaria flare-ups in this subgroup.
A better understanding of this condition and the identification of different subgroups could ultimately, with additional studies, allow for a personalized approach to patient management based on the cholinergic urticaria subgroup and each subgroup's sensitivity to different treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients (> 18 years) with cholinergic urticaria | Experimental | Patient followed at Montpellier University Hospital with a diagnosis of cholinergic urticaria based on diagnostic criteria published in 2016 (Magerl et al): pruritic micropapules triggered by active or passive exposure to heat within 6 months following an exercise challenge test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrared exposure test | Diagnostic Test | Patients will undergo a standardized infrared exposure test (this test is specifically for research purposes) to evaluate the occurrence of cholinergic urticaria reaction. IR exposure test with non-invasive core body temperature measurements, evaluate the occurrence of cholinergic urticaria up to 10 minutes after the end of the test, stop the test at the first clinical signs of urticaria. Desk lamp with infrared bulb, switched on 20cm vertically from the forearm posteriorly for 3 minutes. Reading up to 10 minutes after end of exposure test: diagnosis of cholinergic urticaria flare-up if presence of pruritic micropapules on erythematous background of trunk +/- limbs. Stop the test as soon as urticarial lesions appear. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive infrared test result | the proportion (en percentage) of patients with cholinergic urticaria who develop urticarial lesions following infrared exposure. | During the 3 minutes of exposure to infrared light and the following 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of age between patients with a positive and a negative infrared test | Epidemiological characteristics : age (year) | Baseline |
| Comparison of age of onset of cholinergic urticaria, between patients with a positive and a negative infrared test |
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Inclusion criteria :
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurélie DU-THANH, MD | Contact | 0467 336 906 | +33 | a-du_thanh@chu-montpellier.fr |
| Charlotte Brun, intern | Contact | 0786 050 388 | +33 | Charlotte.brun@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aurélie DU-THANH, MD | CHU de Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Montpellier | Montpellier | hérault | 34 295 | France |
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| ID | Term |
|---|---|
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
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Single-center prospective interventional exploratory pilot study
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|
Epidemiological characteristics : age of onset of cholinergic urticaria (year) |
| Baseline |
| Comparison of sex between patients with a positive and a negative infrared test | Epidemiological characteristics : sexe (male or female) | Baseline |
| Comparison of history of atopy between patients with a positive and a negative infrared test | Epidemiological characteristics : history of atopy and/or angioedema and/or autoimmune diseases, (percentage between groups) | Baseline |
| Comparison of associated chronic urticaria, between patients with a positive and a negative infrared test | Epidemiological characteristics : associated chronic urticaria, | Baseline |
| Comparison of cholinergic urticaria activity score,between patients with a positive and a negative infrared test | Epidemiological characteristics : cholinergic urticaria activity score, CholUAS7 Minimum Score: The minimum score for each item is 0. Maximum Score: The maximum score for each item is 3. For the weekly score (UAS7), which is the sum of daily scores over 7 days, the values range from 0 to 42, with higher values indicating greater disease activity. | Baseline |
| Comparison of triggering factors between patients with a positive and a negative infrared test | Epidemiological characteristics : triggering factors of cholinergic urticaria (physical activity, heat exposure, consumption of hot or spicy foods, emotions), | Baseline |
| Comparison of treatment effectiveness (between patients with a positive and a negative infrared test | Epidemiological characteristics : treatment effectiveness (antihistamines, omalizumab, and other treatments). | Baseline |
| Comparison of time to onset of cholinergic urticaria (exercise) between patients with a positive and a negative infrared test | Clinical characteristics : time to onset of cholinergic urticaria during the exercise test on a stationary bike (seconds) | Baseline |
| Comparison of time to onset of cholinergic urticaria (infrared) between patients with a positive and a negative infrared test | Clinical characteristics : time to onset of cholinergic urticaria during exposure to infrared light (if the test is positive),(seconds) | Baseline |
| Comparison of maximum core temperature between patients with a positive and a negative infrared test | Clinical characteristics : non-invasive measurement of maximum core temperature during the infrared exposure test. (celcius) | Baseline |
| Comparison of average core temperature between patients with a positive and a negative infrared test | Clinical characteristics : non-invasive measurement of average core temperature during the infrared exposure test. (celcius) | Baseline |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |