Chu de Montpellier
Montpellier, hérault, 34 295, France
Location contact
Aurélie Du-Thanh, MD
CONTACT
0467 336 906 ext. +33
Charlotte Brun, intern
CONTACT
0786 050 388 ext. +33
NCT Number: NCT06948188
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Montpellier, hérault, 34 295, France
Aurélie Du-Thanh, MD
CONTACT
0467 336 906 ext. +33
Charlotte Brun, intern
CONTACT
0786 050 388 ext. +33
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Baseline
Epidemiological characteristics :
age (year)
Time frame: Baseline
Epidemiological characteristics :
age of onset of cholinergic urticaria (year)
Time frame: Baseline
Epidemiological characteristics :
sexe (male or female)
Time frame: Baseline
Epidemiological characteristics :
history of atopy and/or angioedema and/or autoimmune diseases, (percentage between groups)
Time frame: Baseline
Epidemiological characteristics :
associated chronic urticaria,
Time frame: 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.
Time frame: Baseline
Epidemiological characteristics :
triggering factors of cholinergic urticaria (physical activity, heat exposure, consumption of hot or spicy foods, emotions),
Time frame: Baseline
Epidemiological characteristics :
treatment effectiveness (antihistamines, omalizumab, and other treatments).
Time frame: Baseline
Clinical characteristics :
time to onset of cholinergic urticaria during the exercise test on a stationary bike (seconds)
Time frame: Baseline
Clinical characteristics :
time to onset of cholinergic urticaria during exposure to infrared light (if the test is positive),(seconds)
Time frame: Baseline
Clinical characteristics :
non-invasive measurement of maximum core temperature during the infrared exposure test. (celcius)
Time frame: Baseline
Clinical characteristics :
non-invasive measurement of average core temperature during the infrared exposure test. (celcius)
Contact information is provided by the study sponsor or research team.
Aurélie DU-THANH, MD
CONTACT
0467 336 906 ext. +33
Charlotte Brun, intern
CONTACT
0786 050 388 ext. +33
University Hospital, Montpellier
Other
Identification of Subpopulations of Patients With Cholinergic Urticaria Based on the Results of Infrared Exposure
Acronym: UCHOL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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