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

NCT06948188 | Not Yet Recruiting

• 1 other identifier: RECHMPL_24_0383
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholinergic Urticaria

Keywords

cholinergic urticaria; urticaria; inducible urticaria; infrared radiation; dermatology, allergology; allergology

Outcome Measures

Primary Outcomes (1)

• Positive infrared test result

  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 Outcomes (12)

• Comparison of age between patients with a positive and a negative infrared test

  Baseline

• Comparison of age of onset of cholinergic urticaria, between patients with a positive and a negative infrared test

  Baseline

• Comparison of sex between patients with a positive and a negative infrared test

  Baseline

• Comparison of history of atopy between patients with a positive and a negative infrared test

  Baseline

• Comparison of associated chronic urticaria, between patients with a positive and a negative infrared test

  Baseline

Study Arms (1)

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

Diagnostic Test: Infrared exposure test

Interventions

Infrared exposure test 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.

Adult patients (> 18 years) with cholinergic urticaria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Chu de Montpellier

Montpellier, hérault, 34 295, France

Location

MeSH Terms

Conditions

Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Aurélie DU-THANH, MD

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie DU-THANH, MD

CONTACT

0467 336 906; a-du_thanh@chu-montpellier.fr

Charlotte Brun, intern

CONTACT

0786 050 388; Charlotte.brun@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center prospective interventional exploratory pilot study

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 29, 2025
• Study Start: May 30, 2025
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

FR (1)