Cholinergic UrticariaUCHOLNCT06948188
Identification of Subpopulations of Patients With Cholinergic Urticaria Based on Infrared Exposure Test Results.
A study testing Infrared exposure test in people with Cholinergic Urticaria, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholinergic Urticaria
- What is being tested?
- Infrared exposure test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2025to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old
- Cholinergic urticaria diagnosed based on the diagnostic criteria published in 2016 (Magerl et al) : pruritic micropapules triggered by active or passive exposure to heat.
- Exercise test performed within the 6 months prior to inclusion.
Who cannot join
- Patients on H1 antihistamines within 72 hours before infrared exposure test
- Patients on any other specific treatment for cholinergic urticaria within a period of 5 plasma half-lives before infrared exposure test
- Patients with exercise-induced anaphylaxis (diet-induced or not)
- Patients with severe forms of cholinergic urticaria: angioedema, respiratory manifestations or anaphylaxis
- Participants who have reached the maximum compensation amount for their participation in research studies.
- Lack of consent (adults, non-emancipated minors, individuals unable to express consent, research conducted in emergency situations, etc.).
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- Not being affiliated with or a beneficiary of a French social security scheme.
- Protected adults (under guardianship, curatorship, or judicial protection).
- Individuals participating in another research study with an ongoing exclusion period.
- Subjects deprived of liberty (Art. L. 1121-6) (by judicial or administrative decision, or involuntary hospitalization).
- Pregnant or breastfeeding women.
- Subjects who cannot read and/or write.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chu de Montpellier
Montpellier, hérault, 34 295
Aurélie Du-Thanh, MD, 0467 336 906 ext. +33, a-du_thanh@chu-montpellier.fr
Charlotte Brun, intern, 0786 050 388 ext. +33, charlotte-brun@chu-montpellier.fr
About this study
Official title: Identification of Subpopulations of Patients With Cholinergic Urticaria Based on the Results of Infrared Exposure
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.
Read the 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.
- Conditions
- Cholinergic Urticaria
- Being tested
- Infrared exposure test
- Keywords
- cholinergic urticaria, urticaria, inducible urticaria, infrared radiation, dermatology, allergology, allergology
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared exposure testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Infrared exposure test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive infrared test result
the proportion (en percentage) of patients with cholinergic urticaria who develop urticarial lesions following infrared exposure.
Measured: During the 3 minutes of exposure to infrared light and the following 10 minutes.
Secondary outcomes (12)
Comparison of age between patients with a positive and a negative infrared test
Epidemiological characteristics :
age (year)
Measured: Baseline
Comparison of age of onset of cholinergic urticaria, between patients with a positive and a negative infrared test
Epidemiological characteristics :
age of onset of cholinergic urticaria (year)
Measured: Baseline
Comparison of sex between patients with a positive and a negative infrared test
Epidemiological characteristics :
sexe (male or female)
Measured: 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)
Measured: Baseline
Comparison of associated chronic urticaria, between patients with a positive and a negative infrared test
Epidemiological characteristics :
associated chronic urticaria,
Measured: 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.
Measured: 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),
Measured: Baseline
Comparison of treatment effectiveness (between patients with a positive and a negative infrared test
Epidemiological characteristics :
treatment effectiveness (antihistamines, omalizumab, and other treatments).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start30 May 2025 (estimated)
- Primary completion7 Apr 2026 (estimated)
- Study completion7 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholinergic UrticariaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center prospective interventional exploratory pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie DU-THANH, MD, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948188
- Sponsor's protocol ID
- RECHMPL_24_0383
- Acronym
- UCHOL
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Subpopulations of Patients With Cholinergic Urticaria Based on the Results of Infrared Exposure
- ClinicalTrials.gov ID
- NCT06948188
- Acronym / sponsor ID
- UCHOL / RECHMPL_24_0383
- Conditions
- Cholinergic Urticaria
- Keywords
- cholinergic urticaria, urticaria, inducible urticaria, infrared radiation, dermatology, allergology, allergology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 7 Apr 2026 (estimated)
- Study completion
- 7 Apr 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center prospective interventional exploratory pilot study
| Arm | Type | Receives |
|---|---|---|
| Adult patients (> 18 years) with cholinergic urticaria | Experimental | Diagnostic Test: Infrared exposure testPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 18 years old
- Cholinergic urticaria diagnosed based on the diagnostic criteria published in 2016 (Magerl et al) : pruritic micropapules triggered by active or passive exposure to heat.
- Exercise test performed within the 6 months prior to inclusion.
Key exclusion criteria (12 listed)
- Patients on H1 antihistamines within 72 hours before infrared exposure test
- Patients on any other specific treatment for cholinergic urticaria within a period of 5 plasma half-lives before infrared exposure test
- Patients with exercise-induced anaphylaxis (diet-induced or not)
- Patients with severe forms of cholinergic urticaria: angioedema, respiratory manifestations or anaphylaxis
- Participants who have reached the maximum compensation amount for their participation in research studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared exposure testPatients 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. | Diagnostic test | Adult patients (> 18 years) with cholinergic urticaria |
Primary outcome
Positive infrared test result
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.
12 secondary outcomes
Comparison of age between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of age of onset of cholinergic urticaria, between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of sex between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of history of atopy between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of associated chronic urticaria, between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of cholinergic urticaria activity score,between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of triggering factors between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of treatment effectiveness (between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of time to onset of cholinergic urticaria (exercise) between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of time to onset of cholinergic urticaria (infrared) between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of maximum core temperature between patients with a positive and a negative infrared test
Time frame: Baseline
Comparison of average core temperature between patients with a positive and a negative infrared test
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cholinergic Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurélie DU-THANH, MD principal investigator
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared exposure test in people with Cholinergic Urticaria, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie DU-THANH, MD (0467 336 906 ext. +33, a-du_thanh@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive infrared test result (time frame: During the 3 minutes of exposure to infrared light and the following 10 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.