Identification of Subpopulations of Patients With Cholinergic Urticaria Based on Infrared Exposure Test Results.
- Conditions
- Cholinergic Urticaria
- Registration Number
- NCT06948188
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Positive infrared test result During the 3 minutes of exposure to infrared light and the following 10 minutes. the proportion (en percentage) of patients with cholinergic urticaria who develop urticarial lesions following infrared exposure.
- Secondary Outcome Measures
Name Time Method Comparison of age between patients with a positive and a negative infrared test Baseline Epidemiological characteristics :
age (year)Comparison of age of onset of cholinergic urticaria, between patients with a positive and a negative infrared test Baseline Epidemiological characteristics :
age of onset of cholinergic urticaria (year)Comparison of sex between patients with a positive and a negative infrared test Baseline Epidemiological characteristics :
sexe (male or female)Comparison of history of atopy between patients with a positive and a negative infrared test Baseline Epidemiological characteristics :
history of atopy and/or angioedema and/or autoimmune diseases, (percentage between groups)Comparison of associated chronic urticaria, between patients with a positive and a negative infrared test Baseline Epidemiological characteristics :
associated chronic urticaria,Comparison of cholinergic urticaria activity score,between patients with a positive and a negative infrared test Baseline 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.Comparison of triggering factors between patients with a positive and a negative infrared test Baseline Epidemiological characteristics :
triggering factors of cholinergic urticaria (physical activity, heat exposure, consumption of hot or spicy foods, emotions),Comparison of treatment effectiveness (between patients with a positive and a negative infrared test Baseline Epidemiological characteristics :
treatment effectiveness (antihistamines, omalizumab, and other treatments).Comparison of time to onset of cholinergic urticaria (exercise) between patients with a positive and a negative infrared test Baseline Clinical characteristics :
time to onset of cholinergic urticaria during the exercise test on a stationary bike (seconds)Comparison of time to onset of cholinergic urticaria (infrared) between patients with a positive and a negative infrared test Baseline Clinical characteristics :
time to onset of cholinergic urticaria during exposure to infrared light (if the test is positive),(seconds)Comparison of maximum core temperature between patients with a positive and a negative infrared test Baseline Clinical characteristics :
non-invasive measurement of maximum core temperature during the infrared exposure test. (celcius)Comparison of average core temperature between patients with a positive and a negative infrared test Baseline Clinical characteristics :
non-invasive measurement of average core temperature during the infrared exposure test. (celcius)
Trial Locations
- Locations (1)
Chu de Montpellier
🇫🇷Montpellier, Hérault, France