ToleranceNCT03952845
Intranasal Capsaicinoid Spray
A study testing Capsaicinoid in people with Tolerance and Capsaicin, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Rhinitis is inflammation of the inside of the nose. Symptoms of rhinitis include itchiness, sneezing, and a "runny" nose (rhinorrhea). There are many different causes for rhinitis, including allergies, age, different irritants in the air, overacting nervous system, and others. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Capsaicinoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to 1 Dec 2030
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- American Association of Anesthesiology Class 1,"A normal, healthy patient" only
Who cannot join
- Age less than 18 years
- Pregnancy
- Previous nasal or paranasal sinus surgery or radiation
- Allergies to capsaicinoids or capsaicinoid containing products (any combination of sweet peppers, or hot peppers).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, B3H 2Y9
David W Forner, MD, 9027895932, david.forner@dal.ca
s M Taylor, MD FRCSC, smarktaylor@eastlink.ca
About this study
Official title: Tolerability of Intranasal Capsaicinoid Spray
Rhinitis is inflammation of the inside of the nose. Symptoms of rhinitis include itchiness, sneezing, and a "runny" nose (rhinorrhea). There are many different causes for rhinitis, including allergies, age, different irritants in the air, overacting nervous system, and others.
Many current treatments for rhinitis are not helpful or are unable to be used for long periods of time. Capsaicin ("Kap-Sey-Uh-Sin") is a natural product that is found in many spicy foods, including hot peppers. This natural product has been used as a lotion to prevent pain, and scientists have found that it may reduce the symptoms of rhinitis when used as a spray in the nose.
Read more
However, capsaicin is known to cause a burning sensation. This study is needed so we can figure out what doses of capsaicin cause this burning sensation, and to what level these doses cause discomfort. Capsaicin can also cause a small degree of tearing from the eyes when used as a spray in the nose, and can also cause the nose to become "runny" (rhinorrhea).
When the safest dose of capsaicin spray is found, that dose can be used to treat people with rhinitis that is not getting better from standard treatments.
Read the detailed description
Inflammation of the nasal mucosa (internal lining of the nose) results in a condition called rhinitis. Patients with rhinitis suffer from nasal stuffiness, congestion, rhinorrhea (nasal discharge), sneezing, and itchiness. Rhinitis affects a large number of people, with several studies estimating that between 10 and 50% of people have rhinitis.
The term rhinitis includes many different diseases that are commonly divided into allergic rhinitis and non-allergic rhinitis. Allergic rhinitis is a result of allergen exposure, with the diagnosis requiring an identifiable offending agent. Common allergens include pollen, molds, animals, and insects. Allergic rhinitis has similar symptoms to those outlined above and can be confirmed by allergy skin testing. There is also a strong association between allergic rhinitis and asthma, with one third of allergic rhinitis patients also suffering from reactive airway disease.
On the other hand, non-allergic rhinitis is a broad category and includes all forms of rhinitis that do not have an identifiable allergic component. Subcategories of non-allergic rhinitis include occupational, gustatory, smoking, hormonal, senile, atrophic, medication-induced, vasomotor (idiopathic), local allergic, and non-allergic rhinitis with eosinophilia syndrome (NARES).
Avoidance of triggers and use of intranasal medication, such as intranasal steroids and intranasal antihistamines, are the mainstays of treatment for non-allergic rhinitis. Combination of intranasal steroid and antihistamine has recently been developed as a single product and approved for the use in both allergic and non-allergic rhinitis. When high volume, clear rhinorrhea is the primary rhinitis symptom, intranasal anticholinergics have shown good effect. Finally, surgical intervention is considered in patients with select non-allergic rhinitis causes, such as vasomotor rhinitis.
The use of intranasal capsaiscinoid spray for treatment of rhinitis has been investigated for many years. The first identifiable trial was in 1991 and showed that both subjective and objective measurements of chronic rhinitis were reduced with repeated applications of intranasal capsaicin.
Capsaicinoids are active ingredients in the plant genus Capsicum, which includes bell peppers, habanero peppers, and jalapeno peppers, amongst others. The most noteworthy of the capsaicinoids is capsaicin. All capsaicinoids are irritants for humans, and they give the Capsicum plants their pungent taste and hot sensation, as well as produce the burning sensation from topical application.
Capsaicinoids are believed to be effective for non-allergic rhinitis due to their ability to block specific nerve fibers in the lining of the nose. Blocking this pathway results in decreased nasal hypersensitivity and leads to reduced nasal obstruction, sneezing, and rhinorrhea.
More recently, a systematic review for the Cochrane Collaboration was carried out. Four studies were included in the review, representing 302 patients. The authors of the review conclude that given many therapeutic options for non-allergic rhinitis are ineffective, the use of intranasal capsaicinoid as possible treatment modality is reasonable.
It should be noted that each of the four studies included in the review utilized a different dose of capsaiscinoid, and indeed a different capsaiscinoid altogether.
Despite many trials documenting the efficacy of intranasal capsaicinoids for non-allergic rhinitis, tolerability of the intervention is poorly studied. Also of note is that many of the current studies utilizing intranasal capsaicinoids have used some form of topical anesthetic in order to deliver high doses.
Therefore, given that intranasal capsaicinoid spray is an enticing treatment option for non-allergic rhinitis in terms of efficacy, and there is a dearth of reliable tolerability studies, we would seek to identify the side effect profile of a naturally sourced intranasal capsaicin spray. As pelargonic acid vanillylamide (PAVA) is the most studied capsaicinoid in terms of efficacy in humans, we propose to utilize this for our study.
The proposed study would address the following objectives:
- Determine the rate and severity of intranasal burning sensation and pain with administration of intranasal PAVA in an otherwise healthy population with no history of medical or surgical nasal disease
- Measured using both a Likert scale and a Visual Analogue Scale (VAS)
- Determine the rate and severity of lacrimation with administration of intranasal PAVA in an otherwise healthy population with no history of medical or surgical nasal disease
- Measured using a Likert scale
- Determine the rate and severity of rhinorrhea with administration of intranasal PAVA in an otherwise healthy population with no history of medical or surgical nasal disease
- Measured using a Likert scale
- Determine the overall patient perceived tolerability of intranasal PAVA administration in an otherwise healthy population with no history of medical or surgical nasal disease a. Considered an overall combined measure of all Likert scales and VAS
- Being tested
- Capsaicinoid
- Keywords
- Capsaicin, Rhinitis
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinoidOther
This is a tolerability study on doses lower than previously published for the use of intranasal capsaicinoid in the treatment of rhinitis
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Capsaicin | Experimental | Separate patients will be given escalating doses of intranasal capsaicinoid spray Receives: Other: Capsaicinoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Visual Analogue Scale (VAS) - Change from 1 hour after pre-treatment baseline
Visual analogue scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. The visual analogue scale will be presented as a single line scale that is 100mm (0mm to 100mm) in length that the patient my place a mark on to indicate the severity of their pain. The distance (mm) of this mark from the 0 set point will determine the severity score.
Measured: Pre-treatment and Immediate (1 hour after treatment)
Pain - Visual Analogue Scale (VAS) - Change from 1 week after pre-treatment baseline
Visual analogue scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. The visual analogue scale will be presented as a single line scale that is 100mm (0mm to 100mm) in length that the patient my place a mark on to indicate the severity of their pain. The distance (mm) of this mark from the 0 set point will determine the severity score.
Measured: Pre-treatment and Delayed (1 week after treatment)
Rhinorrhea - Likert - Change from 1 hour after pre-treatment baseline
Likert scale will be used to analyze participant's perception of rhinorrhea ("runny-nose") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Measured: Pre-treatment and Immediate (1 hour after treatment)
Rhinorrhea - Likert - Change from 1week after pre-treatment baseline
Likert scale will be used to analyze participant's perception of rhinorrhea ("runny-nose") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Measured: Pre-treatment and Delayed (1 week after treatment)
Lacrimation - Likert - Change from 1 hour after pre-treatment baseline
Likert scale will be used to analyze participant's perception of lacrimation ("teary-eyes") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Measured: Pre-treatment and Immediate (1 hour after treatment)
Lacrimation - Likert - Change from 1 week after pre-treatment baseline
Likert scale will be used to analyze participant's perception of lacrimation ("teary-eyes") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Measured: Pre-treatment and Delayed (1 week after treatment)
Pain - Likert - Change from 1 hour after pre-treatment baseline
Likert scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Measured: Pre-treatment and Immediate (1 hour after treatment)
Pain - Likert - Change from 1 week after pre-treatment baseline
Likert scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Measured: Pre-treatment and Delayed (1 week after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In brief, three consecutive patients will receive the initial intervention dose, and complete a post-intervention assessment. Subsequent cohorts receive escalating doses that are determined in advance (see below). If no patients in the initial cohort experience a dose limiting toxicity, three new patients will be recruited into the subsequent cohort and each will receive the escalated dose. This process continues on until at least one patient in a cohort experiences a dose limiting toxicity. When this occurs, three new patients will be recruited but will receive the same dose as the patient who experienced a dose limiting toxicity. If no patients in this new cohort experience a dose limiting toxicity, three additional patients will be recruited and will receive the next predetermined escalated dose. However, if two of six patients experience a dose limiting toxicity, the trial is considered complete and the dose these six patients received is considered the maximum tolerated dose.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S Mark Taylor, MD FRCSC, Principal investigator, Dalhousie UniversityDavid WA Forner, MD, Study director, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952845
- Sponsor's protocol ID
- 1024481
- Status last verified
- Aug 2024
- First submitted
- 11 May 2019
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of Intranasal Capsaicinoid Spray
- ClinicalTrials.gov ID
- NCT03952845
- Acronym / sponsor ID
- 1024481
- Keywords
- Capsaicin, Rhinitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 16 May 2019 (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.
Rhinitis is inflammation of the inside of the nose. Symptoms of rhinitis include itchiness, sneezing, and a "runny" nose (rhinorrhea). There are many different causes for rhinitis, including allergies, age, different irritants in the air, overacting nervous system, and others.
Many current treatments for rhinitis are not helpful or are unable to be used for long periods of time. Capsaicin ("Kap-Sey-Uh-Sin") is a natural product that is found in many spicy foods, including hot peppers. This natural product has been used as a lotion to prevent pain, and scientists have found that it may reduce the symptoms of rhinitis when used as a spray in the nose.
However, capsaicin is known to cause a burning sensation. This study is needed so we can figure out what doses of capsaicin cause this burning sensation, and to what level these doses cause discomfort. Capsaicin can also cause a small degree of tearing from the eyes when used as a spray in the nose, and can also cause the nose to become "runny" (rhinorrhea).
When the safest dose of capsaicin spray is found, that dose can be used to treat people with rhinitis that is not getting better from standard treatments.
Detailed description
Inflammation of the nasal mucosa (internal lining of the nose) results in a condition called rhinitis. Patients with rhinitis suffer from nasal stuffiness, congestion, rhinorrhea (nasal discharge), sneezing, and itchiness. Rhinitis affects a large number of people, with several studies estimating that between 10 and 50% of people have rhinitis.
The term rhinitis includes many different diseases that are commonly divided into allergic rhinitis and non-allergic rhinitis. Allergic rhinitis is a result of allergen exposure, with the diagnosis requiring an identifiable offending agent. Common allergens include pollen, molds, animals, and insects. Allergic rhinitis has similar symptoms to those outlined above and can be confirmed by allergy skin testing. There is also a strong association between allergic rhinitis and asthma, with one third of allergic rhinitis patients also suffering from reactive airway disease.
On the other hand, non-allergic rhinitis is a broad category and includes all forms of rhinitis that do not have an identifiable allergic component. Subcategories of non-allergic rhinitis include occupational, gustatory, smoking, hormonal, senile, atrophic, medication-induced, vasomotor (idiopathic), local allergic, and non-allergic rhinitis with eosinophilia syndrome (NARES).
Avoidance of triggers and use of intranasal medication, such as intranasal steroids and intranasal antihistamines, are the mainstays of treatment for non-allergic rhinitis. Combination of intranasal steroid and antihistamine has recently been developed as a single product and approved for the use in both allergic and non-allergic rhinitis. When high volume, clear rhinorrhea is the primary rhinitis symptom, intranasal anticholinergics have shown good effect. Finally, surgical intervention is considered in patients with select non-allergic rhinitis causes, such as vasomotor rhinitis.
The use of intranasal capsaiscinoid spray for treatment of rhinitis has been investigated for many years. The first identifiable trial was in 1991 and showed that both subjective and objective measurements of chronic rhinitis were reduced with repeated applications of intranasal capsaicin.
Capsaicinoids are active ingredients in the plant genus Capsicum, which includes bell peppers, habanero peppers, and jalapeno peppers, amongst others. The most noteworthy of the capsaicinoids is capsaicin. All capsaicinoids are irritants for humans, and they give the Capsicum plants their pungent taste and hot sensation, as well as produce the burning sensation from topical application.
Capsaicinoids are believed to be effective for non-allergic rhinitis due to their ability to block specific nerve fibers in the lining of the nose. Blocking this pathway results in decreased nasal hypersensitivity and leads to reduced nasal obstruction, sneezing, and rhinorrhea.
More recently, a systematic review for the Cochrane Collaboration was carried out. Four studies were included in the review, representing 302 patients. The authors of the review conclude that given many therapeutic options for non-allergic rhinitis are ineffective, the use of intranasal capsaicinoid as possible treatment modality is reasonable.
It should be noted that each of the four studies included in the review utilized a different dose of capsaiscinoid, and indeed a different capsaiscinoid altogether.
Despite many trials documenting the efficacy of intranasal capsaicinoids for non-allergic rhinitis, tolerability of the intervention is poorly studied. Also of note is that many of the current studies utilizing intranasal capsaicinoids have used some form of topical anesthetic in order to deliver high doses.
Therefore, given that intranasal capsaicinoid spray is an enticing treatment option for non-allergic rhinitis in terms of efficacy, and there is a dearth of reliable tolerability studies, we would seek to identify the side effect profile of a naturally sourced intranasal capsaicin spray. As pelargonic acid vanillylamide (PAVA) is the most studied capsaicinoid in terms of efficacy in humans, we propose to utilize this for our study.
The proposed study would address the following objectives:
- Determine the rate and severity of intranasal burning sensation and pain with administration of intranasal PAVA in an otherwise healthy population with no history of medical or surgical nasal disease
- Measured using both a Likert scale and a Visual Analogue Scale (VAS)
- Determine the rate and severity of lacrimation with administration of intranasal PAVA in an otherwise healthy population with no history of medical or surgical nasal disease
- Measured using a Likert scale
- Determine the rate and severity of rhinorrhea with administration of intranasal PAVA in an otherwise healthy population with no history of medical or surgical nasal disease
- Measured using a Likert scale
- Determine the overall patient perceived tolerability of intranasal PAVA administration in an otherwise healthy population with no history of medical or surgical nasal disease a. Considered an overall combined measure of all Likert scales and VAS
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In brief, three consecutive patients will receive the initial intervention dose, and complete a post-intervention assessment. Subsequent cohorts receive escalating doses that are determined in advance (see below). If no patients in the initial cohort experience a dose limiting toxicity, three new patients will be recruited into the subsequent cohort and each will receive the escalated dose. This process continues on until at least one patient in a cohort experiences a dose limiting toxicity. When this occurs, three new patients will be recruited but will receive the same dose as the patient who experienced a dose limiting toxicity. If no patients in this new cohort experience a dose limiting toxicity, three additional patients will be recruited and will receive the next predetermined escalated dose. However, if two of six patients experience a dose limiting toxicity, the trial is considered complete and the dose these six patients received is considered the maximum tolerated dose.
| Arm | Type | Receives |
|---|---|---|
| Intranasal Capsaicin | Experimental | Other: CapsaicinoidSeparate patients will be given escalating doses of intranasal capsaicinoid spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults
- American Association of Anesthesiology Class 1,"A normal, healthy patient" only
Key exclusion criteria (4 listed)
- Age less than 18 years
- Pregnancy
- Previous nasal or paranasal sinus surgery or radiation
- Allergies to capsaicinoids or capsaicinoid containing products (any combination of sweet peppers, or hot peppers).
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 |
|---|---|---|
| CapsaicinoidThis is a tolerability study on doses lower than previously published for the use of intranasal capsaicinoid in the treatment of rhinitis | Other | Intranasal Capsaicin |
Primary outcome
Pain - Visual Analogue Scale (VAS) - Change from 1 hour after pre-treatment baseline
Time frame: Pre-treatment and Immediate (1 hour after treatment)
Visual analogue scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. The visual analogue scale will be presented as a single line scale that is 100mm (0mm to 100mm) in length that the patient my place a mark on to indicate the severity of their pain. The distance (mm) of this mark from the 0 set point will determine the severity score.
Pain - Visual Analogue Scale (VAS) - Change from 1 week after pre-treatment baseline
Time frame: Pre-treatment and Delayed (1 week after treatment)
Visual analogue scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. The visual analogue scale will be presented as a single line scale that is 100mm (0mm to 100mm) in length that the patient my place a mark on to indicate the severity of their pain. The distance (mm) of this mark from the 0 set point will determine the severity score.
Rhinorrhea - Likert - Change from 1 hour after pre-treatment baseline
Time frame: Pre-treatment and Immediate (1 hour after treatment)
Likert scale will be used to analyze participant's perception of rhinorrhea ("runny-nose") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Rhinorrhea - Likert - Change from 1week after pre-treatment baseline
Time frame: Pre-treatment and Delayed (1 week after treatment)
Likert scale will be used to analyze participant's perception of rhinorrhea ("runny-nose") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Lacrimation - Likert - Change from 1 hour after pre-treatment baseline
Time frame: Pre-treatment and Immediate (1 hour after treatment)
Likert scale will be used to analyze participant's perception of lacrimation ("teary-eyes") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Lacrimation - Likert - Change from 1 week after pre-treatment baseline
Time frame: Pre-treatment and Delayed (1 week after treatment)
Likert scale will be used to analyze participant's perception of lacrimation ("teary-eyes") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Pain - Likert - Change from 1 hour after pre-treatment baseline
Time frame: Pre-treatment and Immediate (1 hour after treatment)
Likert scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
Pain - Likert - Change from 1 week after pre-treatment baseline
Time frame: Pre-treatment and Delayed (1 week after treatment)
Likert scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.
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 21 Aug 2024.
- 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.
S Mark Taylor, MD FRCSC principal investigator
Dalhousie University
David WA Forner, MD study director
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicinoid in people with Tolerance and Capsaicin, run by Nova Scotia Health Authority at 1 site 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 2 inclusion and 4 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 21 Aug 2024. 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 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. 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 David WA Forner, MD (902 473 2222 ext. 8247, david.forner@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - Visual Analogue Scale (VAS) - Change from 1 hour after pre-treatment baseline (time frame: Pre-treatment and Immediate (1 hour after treatment)). The study lists 8 primary outcomes in all. 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 21 Aug 2024.