Urticaria ColdNCT06127992
Non-invasive Diagnosis of Cold Urticaria
A study testing Cold stimulation tests / critical temperature threshold in people with Urticaria Cold, run by City Clinical Hospital No.52 of Moscow Healthcare Department at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urticaria Cold
- What is being tested?
- Cold stimulation tests / critical temperature threshold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteRussia
- Study dates
- 12 May 2023to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cold urticaria
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photoplethysmography for Non-invasive Diagnosis of Cold Urticaria
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
- Being tested
- Cold stimulation tests / critical temperature threshold
- Medical subject headings
- Cold Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold stimulation tests / critical temperature thresholdDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Typical ColdU | Experimental | 39 patients had typical ColdU confirmed by positive ICT and TempTest® CSTs. Receives: Device: Cold stimulation tests / critical temperature threshold |
| Atypical ColdU | Experimental | 24 patients had atypical ColdU with negative ICT and TempTest® CSTs. Receives: 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 Receives: Device: Cold stimulation tests / critical temperature threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 min after the end of cold exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start12 May 2023
- Primary completion27 Nov 2023 (estimated)
- Study completion27 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urticaria ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- City Clinical Hospital No.52 of Moscow Healthcare Department
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daria Fomina, City Clinical Hospital No.52 of Moscow Healthcare Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127992
- Sponsor's protocol ID
- 06/0621
- Status last verified
- Nov 2023
- First submitted
- 18 Sep 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoplethysmography for Non-invasive Diagnosis of Cold Urticaria
- ClinicalTrials.gov ID
- NCT06127992
- Acronym / sponsor ID
- 06/0621
- Conditions
- Urticaria Cold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (actual)
- Lead sponsor
- City Clinical Hospital No.52 of Moscow Healthcare DepartmentUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 27 Nov 2023 (estimated)
- Study completion
- 27 Nov 2023 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Typical ColdU | Experimental | Device: Cold stimulation tests / critical temperature threshold39 patients had typical ColdU confirmed by positive ICT and TempTest® CSTs. |
| Atypical ColdU | Experimental | Device: Cold stimulation tests / critical temperature threshold24 patients had atypical ColdU with negative ICT and TempTest® CSTs. |
| Control group | Other | Device: Cold stimulation tests / critical temperature threshold15 healthy controls (HCs) who had no history of pathological reactions associated with cold exposure, and all of them had negative CSTs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cold urticaria
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold stimulation tests / critical temperature thresholdICT 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. | Device | Atypical ColdU, Control group, Typical ColdU |
Primary outcome
Photoplethysmography amplitude
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold stimulation tests / critical temperature threshold in people with Urticaria Cold, run by City Clinical Hospital No.52 of Moscow Healthcare Department at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photoplethysmography amplitude (time frame: 10 min after the end of cold exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.