Non-invasive Diagnosis of Cold Urticaria

NCT06127992 | Unknown DMC

• 1 other identifier: 06/0621
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators subjected 63 patients (39 with typical Cold urticaria and 24 with atypical Cold urticaria ) and 15 healthy controls to TempTest® cold stimulation tests and critical temperature threshold assessments. Blood microcirculation photoplethysmography measurements were performed 5 min before and 10 min after the ice cube on the volar forearm.

Conditions

Urticaria Cold

Outcome Measures

Primary Outcomes (1)

• Photoplethysmography amplitude

  To compute the blood flow signal, we subtracted slowly time-varying background and frequency components out of the cardiovascular-related range of 0.3-7 Hz. The resulting well-matched, noise-free and intensity-corrected blood flow images are suited for PPG calculation by averaging the intensity pixel values of each frame. The PPG amplitude is proportional to the amount of arterial blood that reaches the visualized skin area and thus characterizes its blood perfusion. It is measured in arbitrary units (AU). We performed photoplethysmographic assessments of the volar forearm of all patients 5 minutes before and 10 minutes after the beginning and end of ice cube application.

  10 min after the end of cold exposure

Study Arms (3)

Typical ColdU

EXPERIMENTAL

39 patients had typical ColdU confirmed by positive ICT and TempTest® CSTs.

Device: Cold stimulation tests / critical temperature threshold

Atypical ColdU

EXPERIMENTAL

24 patients had atypical ColdU with negative ICT and TempTest® CSTs.

Device: Cold stimulation tests / critical temperature threshold

Control group

OTHER

15 healthy controls (HCs) who had no history of pathological reactions associated with cold exposure, and all of them had negative CSTs

Device: Cold stimulation tests / critical temperature threshold

Interventions

Cold stimulation tests / critical temperature threshold DEVICE

ICT was performed following a standard protocol. Briefly, a melting ice cube in thin plastic bag was placed on the volar surface of the patient forearm for 5 min, with macroscopic assessment of the test site 10 min later. TempTest® CSTs were done with TempTest® 4.0 (Courage \& Khazaka, Cologne, Germany), which has a single Peltier element (length: 350 mm, width: 2 mm) that provides a continuous temperature gradient from 4°C to 44°C. The use of TempTest® allows for reproducible and standardized cold (and heat) provocation tests and the identification of CTTs. TempTest® CST results were also assessed 10 min after the end of cold exposure.

Atypical ColdU; Control group; Typical ColdU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cold urticaria

Sponsors & Collaborators

• City Clinical Hospital No.52 of Moscow Healthcare Department: lead

Study Sites (1)

Moscow City Clinical Hospital 52

Moscow, 123182, Russia

Location

MeSH Terms

Conditions

Cold Urticaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Center of Allergy and Immunology

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: November 13, 2023
• Study Start: May 12, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

RU (1)