Identification of Subpopulations of Patients With Cholinergic Urticaria Based on Infrared Exposure Test Results.

NCT ID: NCT06948188

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2026-04-07

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.

Conditions

Cholinergic Urticaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Adult patients (> 18 years) with cholinergic urticaria

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

Group Type: EXPERIMENTAL

Infrared exposure test

Intervention Type: 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.

Interventions

Infrared exposure 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.).
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie DU-THANH, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Montpellier

Locations

Chu de Montpellier

Montpellier, hérault, France

Countries

France

Central Contacts

Aurélie DU-THANH, MD

Role: CONTACT

a-du_thanh@chu-montpellier.fr

0467 336 906 ext. +33

Charlotte Brun, intern

Role: CONTACT

Charlotte.brun@chu-montpellier.fr

0786 050 388 ext. +33

Facility Contacts

Aurélie Du-Thanh, MD

Role: primary

a-du_thanh@chu-montpellier.fr

0467 336 906 ext. +33

Charlotte Brun, intern

Role: backup

charlotte-brun@chu-montpellier.fr

0786 050 388 ext. +33

Other Identifiers

RECHMPL_24_0383

Identifier Type: -

Identifier Source: org_study_id