Non-invasive Diagnosis of Cold Urticaria

Not Applicable

Active, not recruiting

• Conditions: Urticaria Cold
• Interventions: Device: Cold stimulation tests / critical temperature threshold

• Registration Number: NCT06127992
• Lead Sponsor: City Clinical Hospital No.52 of Moscow Healthcare Department

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-12
• Study First Submitted: 2023-09-18
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Cold urticaria

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Cold stimulation tests / critical temperature threshold	15 healthy controls (HCs) who had no history of pathological reactions associated with cold exposure, and all of them had negative CSTs
Typical ColdU	Cold stimulation tests / critical temperature threshold	39 patients had typical ColdU confirmed by positive ICT and TempTest® CSTs.
Atypical ColdU	Cold stimulation tests / critical temperature threshold	24 patients had atypical ColdU with negative ICT and TempTest® CSTs.

Primary Outcome Measures

Name	Time	Method
Photoplethysmography amplitude	10 min after the end of cold exposure	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.

Trial Locations

Locations (1)

Moscow City Clinical Hospital 52; 🇷🇺 Moscow, Russian Federation