Non-invasive Diagnosis of Cold Urticaria

Sponsor

City Clinical Hospital No.52 of Moscow Healthcare Department (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06127992

Collaborator

(none)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urticaria Cold	Device: Cold stimulation tests / critical temperature threshold	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Photoplethysmography for Non-invasive Diagnosis of Cold Urticaria

Actual Study Start Date :

May 12, 2023

Anticipated Primary Completion Date :

Nov 27, 2023

Anticipated Study Completion Date :

Nov 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Typical ColdU 39 patients had typical ColdU confirmed by positive ICT and TempTest® CSTs.	Device: Cold stimulation tests / critical temperature threshold 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.
Experimental: Atypical ColdU 24 patients had atypical ColdU with negative ICT and TempTest® CSTs.	Device: Cold stimulation tests / critical temperature threshold 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.
Other: Control group 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 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.

Arm

Intervention/Treatment

Experimental: Typical ColdU

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

Device: Cold stimulation tests / critical temperature threshold

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.

Experimental: Atypical ColdU

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

Device: Cold stimulation tests / critical temperature threshold

Other: Control group

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Cold urticaria

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moscow City Clinical Hospital 52	Moscow		Russian Federation	123182

Sponsors and Collaborators

City Clinical Hospital No.52 of Moscow Healthcare Department

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daria Fomina, Head of the Center of Allergy and Immunology, City Clinical Hospital No.52 of Moscow Healthcare Department

ClinicalTrials.gov Identifier:

NCT06127992

Other Study ID Numbers:

06/0621

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urticaria

Study Results

No Results Posted as of Nov 13, 2023