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

April 23, 2025 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 3 minutes of exposure to infrared light and the following 10 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of age between patients with a positive and a negative infrared test
Time Frame: Baseline

Epidemiological characteristics :

age (year)
Baseline
Comparison of age of onset of cholinergic urticaria, between patients with a positive and a negative infrared test
Time Frame: Baseline

Epidemiological characteristics :

age of onset of cholinergic urticaria (year)
Baseline
Comparison of sex between patients with a positive and a negative infrared test
Time Frame: Baseline

Epidemiological characteristics :

sexe (male or female)
Baseline
Comparison of history of atopy between patients with a positive and a negative infrared test
Time Frame: Baseline

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
Time Frame: Baseline

Epidemiological characteristics :

associated chronic urticaria,
Baseline
Comparison of cholinergic urticaria activity score,between patients with a positive and a negative infrared test
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.
Baseline
Comparison of triggering factors between patients with a positive and a negative infrared test
Time Frame: Baseline

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
Time Frame: Baseline

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
Time Frame: Baseline

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
Time Frame: Baseline

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
Time Frame: Baseline

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
Time Frame: Baseline

Clinical characteristics :

non-invasive measurement of average core temperature during the infrared exposure test. (celcius)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Aurélie DU-THANH, MD, CHU de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2025

Primary Completion (Estimated)

April 7, 2026

Study Completion (Estimated)

April 7, 2026

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL_24_0383

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholinergic Urticaria

Clinical Trials on Infrared exposure test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe