AllergyFROSTNCT07917312
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
A study testing Food (sucrose), Food (popsicle) and Food(Sucrose and cold) in people with Allergy and Food Allergies, run by Philippe Bégin at 2 sites in Canada.
Trial summary
This is a two-center, randomized, open-label, factorial controlled trial. This trial aims to evaluate the efficacy of exposure to sucrose and ice, alone and in combination, compared to control, in reducing oral pruritus during allergy procedures. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Allergy, Food Allergies, Oral Pruritus
- What is being tested?
- Food (sucrose), Food (popsicle) and Food(Sucrose and cold)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 8 years and older.
- Have a clinically diagnosed IgE-mediated food allergy, supported by a compatible clinical history and evidence of IgE sensitization (e.g., skin prick testing and/or serum food-specific IgE), as determined by the treating allergist.
- Undergoing an oral food challenge or initiating oral immunotherapy / undergoing an oral immunotherapy dose escalation.
- Develop oral pruritus following allergen administration with a minimum score of 3/10 on the ICH Numeric Rating Scale (ICH NRS).
- Be able to assess and report their symptoms using the ICH NRS.
- Provide informed consent to participate in the study (and assent, where applicable, in accordance with local regulations).
Who cannot join
- Any oral condition or pathology that could interfere with the perception, assessment, or interpretation of oral pruritus symptoms.
- Presence or development of systemic allergic symptoms for which epinephrine administration would be clinically indicated.
- Poorly controlled diabetes mellitus, as defined by the treating physician.
- Any condition affecting oral sensation or the ability to accurately communicate symptoms using the ICH NRS.
- Cold urticaria or significant hypersensitivity to cold.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
CHUM
Montreal, Quebec, H2X 0C1
Philippe Bégin, 514-345-4931 ext. 2668, philippe.begin.med@ssss.gouv.qc.ca
Chu Sainte-Justine
Montreal, Quebec, H3T1C5
Maitena montuzet, 514-345-4931 ext. 117375, maitena.montuzet.hsj@ssss.gouv.qc.ca
About this study
Official title: A Randomized Controlled 2×2 Factorial Study Evaluating Sucrose and Cold for the Treatment of Oral Pruritus During Allergy Procedures
This is a two-center, randomized, open-label, factorial controlled trial. This trial aims to evaluate the efficacy of exposure to sucrose and ice, alone and in combination, compared to control, in reducing oral pruritus during allergy procedures.
The population will include patients aged 8 years and older presenting with oral pruritus in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.
Read more
Clinically significant oral pruritus will be defined as a pruritus intensity of ≥3/10 on the ICH NRS, and a symptom bothersome enough that the patient would normally seek treatment.
Eligible participants will be randomized to one of four groups (1:1:1:1 ratio):
- Sucrose only (3.5 g granulated sugar)
- Cold only (20 mL of ice in the form of popsicle)
- Sucrose + cold (20 mL frozen sucrose solution)
- Control (20 mL room-temperature water)
Participants will be asked to report when the pruritus has decreased to a level at which they would not normally seek treatment, as well as when it has completely resolved.
The evolution of oral pruritus will be assessed using an 11-point Numeric Rating Scale (ICH NRS). Pruritus intensity will be measured every 30 seconds during the first 5 minutes after administration of the study intervention and then every 1 minute until 15 minutes post-intervention.
- Conditions
- Allergy, Food Allergies, Oral Pruritus, Environmental Allergies
- Being tested
- Food (sucrose), Food (popsicle), Food(Sucrose and cold), Water (Placebo)
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity, Environmental Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food (sucrose)Other
Sucrose only (3.5 g granulated sugar)
Food (popsicle)Other
Cold only (20 mL of ice in the form of popsicle)
Food(Sucrose and cold)Other
Sucrose + cold (20 mL frozen sucrose solution)
Water (Placebo)Other
20 mL room-temperature water
| Study group | Role | What they receive |
|---|---|---|
| Sucrose only | Active comparator | 3.5 g granulated sugar Receives: Other: Food (sucrose) |
| Cold only | Active comparator | 20 mL of ice in the form of popsicle Receives: Other: Food (popsicle) |
| Sucrose and cold | Active comparator | 20 mL frozen sucrose solution Receives: Other: Food(Sucrose and cold) |
| Water | Placebo comparator | 20 mL room-temperature water Receives: Other: Water (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of ICH NRS scores
Pruritus intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate greater pruritus intensity and therefore a worse outcome.
Measured: From baseline (pre-intervention) through 15 minutes post-intervention.
Secondary outcomes (3)
Time to reduction of at least 2 points from the baseline ICH NRS score.
A reduction of at least 2 points on the 11-point Numerical Rating Scale (0-10) indicates an improvement in pruritus intensity.
Measured: From baseline (pre-intervention) through 15 minutes post-intervention.
Time to complete resolution of oral pruritus (ICH NRS score of 0).
Complete resolution of oral pruritus is defined as an Intra-episode Clinical Numerical Rating Scale (ICH NRS) score of 0, corresponding to no itching. The scale ranges from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus severity and therefore a worse outcome.
Measured: From baseline (pre-intervention) through 15 minutes post-intervention.
Time to a decrease in oral pruritus intensity to a level at which the participant would normally not seek treatment.
Time from intervention administration to the first assessment at which oral pruritus intensity decreases to a level that the participant reports would not normally prompt them to seek treatment. Pruritus intensity is assessed using the Intra-episode Clinical Numerical Rating Scale (ICH NRS), ranging from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus intensity and a worse outcome.
Measured: From baseline (pre-intervention) through 15 minutes post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philippe Bégin
- Sponsor type
- University, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), Sainte Justine Hospital Research Institute
- Responsible party
- Sponsor-investigator, Philippe Bégin, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917312
- Sponsor's protocol ID
- MP-21-2027-10364
- Acronym
- FROST
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled 2×2 Factorial Study Evaluating Sucrose and Cold for the Treatment of Oral Pruritus During Allergy Procedures
- ClinicalTrials.gov ID
- NCT07917312
- Acronym / sponsor ID
- FROST / MP-21-2027-10364
- Conditions
- Allergy, Food Allergies, Oral Pruritus, Environmental Allergies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Philippe BéginUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), Sainte Justine Hospital Research Institute
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 4 Nov 2026 (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.
This is a two-center, randomized, open-label, factorial controlled trial. This trial aims to evaluate the efficacy of exposure to sucrose and ice, alone and in combination, compared to control, in reducing oral pruritus during allergy procedures.
The population will include patients aged 8 years and older presenting with oral pruritus in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.
Clinically significant oral pruritus will be defined as a pruritus intensity of ≥3/10 on the ICH NRS, and a symptom bothersome enough that the patient would normally seek treatment.
Eligible participants will be randomized to one of four groups (1:1:1:1 ratio):
- Sucrose only (3.5 g granulated sugar)
- Cold only (20 mL of ice in the form of popsicle)
- Sucrose + cold (20 mL frozen sucrose solution)
- Control (20 mL room-temperature water)
Participants will be asked to report when the pruritus has decreased to a level at which they would not normally seek treatment, as well as when it has completely resolved.
The evolution of oral pruritus will be assessed using an 11-point Numeric Rating Scale (ICH NRS). Pruritus intensity will be measured every 30 seconds during the first 5 minutes after administration of the study intervention and then every 1 minute until 15 minutes post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sucrose only | Active comparator | Other: Food (sucrose)3.5 g granulated sugar |
| Cold only | Active comparator | Other: Food (popsicle)20 mL of ice in the form of popsicle |
| Sucrose and cold | Active comparator | Other: Food(Sucrose and cold)20 mL frozen sucrose solution |
| Water | Placebo comparator | Other: Water (Placebo)20 mL room-temperature water |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 8 years and older.
- Have a clinically diagnosed IgE-mediated food allergy, supported by a compatible clinical history and evidence of IgE sensitization (e.g., skin prick testing and/or serum food-specific IgE), as determined by the treating allergist.
- Undergoing an oral food challenge or initiating oral immunotherapy / undergoing an oral immunotherapy dose escalation.
- Develop oral pruritus following allergen administration with a minimum score of 3/10 on the ICH Numeric Rating Scale (ICH NRS).
- Be able to assess and report their symptoms using the ICH NRS.
Key exclusion criteria (5 listed)
- Any oral condition or pathology that could interfere with the perception, assessment, or interpretation of oral pruritus symptoms.
- Presence or development of systemic allergic symptoms for which epinephrine administration would be clinically indicated.
- Poorly controlled diabetes mellitus, as defined by the treating physician.
- Any condition affecting oral sensation or the ability to accurately communicate symptoms using the ICH NRS.
- Cold urticaria or significant hypersensitivity to cold.
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 |
|---|---|---|
| Food (sucrose)Sucrose only (3.5 g granulated sugar) | Other | Sucrose only |
| Food (popsicle)Cold only (20 mL of ice in the form of popsicle) | Other | Cold only |
| Food(Sucrose and cold)Sucrose + cold (20 mL frozen sucrose solution) | Other | Sucrose and cold |
| Water (Placebo)20 mL room-temperature water | Other | Water |
Primary outcome
Area under the curve (AUC) of ICH NRS scores
Time frame: From baseline (pre-intervention) through 15 minutes post-intervention.
Pruritus intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate greater pruritus intensity and therefore a worse outcome.
3 secondary outcomes
Time to reduction of at least 2 points from the baseline ICH NRS score.
Time frame: From baseline (pre-intervention) through 15 minutes post-intervention.
Time to complete resolution of oral pruritus (ICH NRS score of 0).
Time frame: From baseline (pre-intervention) through 15 minutes post-intervention.
Time to a decrease in oral pruritus intensity to a level at which the participant would normally not seek treatment.
Time frame: From baseline (pre-intervention) through 15 minutes post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food (sucrose), Food (popsicle) and Food(Sucrose and cold) in people with Allergy and Food Allergies, run by Philippe Bégin at 2 sites in Canada.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ginevra Lacatusu (514-345-4931 ext. 2670, ginevra.lacatusu.hsj@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of ICH NRS scores (time frame: From baseline (pre-intervention) through 15 minutes post-intervention.). 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 4 Nov 2026.