PainLipTRPNCT01963910
Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream
A study of Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
Capsaicin is a TRPV1 (transient receptor potential vanilloid 1) agonist, causing pain upon application. The investigators wish to determine whether mannitol blocks the effect of capsaicin application. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Jan 2014
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 19 and 80 years
Who cannot join
- Diet containing capsaicin (Cayenne pepper, capsicum) (spicy foods), more than once a week.
- Meal containing capsaicin (spicy foods) within 5 days prior to the experiment.
- Any lesion, cracking, cold sore or abrasion on the lips
- Inability to tolerate capsaicin containing "spicy foods"
- Wearing lipstick or lip balm on the upper lip
- Inability to fill out an NRS pain scale
Show all 10Show fewer
- Use of painkilling medication, within 24 hours of the study.
- Allergy to any of the ingredients of the creams, or to mannitol
- History of contact or allergic dermatitis
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. Helene Bertrand Inc., 220-1940 Lonsdale Ave.
North Vancouver, British Columbia, V7M 2K2
About this study
Capsaicin is a TRPV1 (transient receptor potential vanilloid 1) agonist, causing pain upon application. The investigators wish to determine whether mannitol blocks the effect of capsaicin application. As both cream bases are identical and mannitol addition is the only difference between the creams, if the mannitol cream is more effective in blocking the effect of capsaicin on the TRPV1 (transient receptor potential vanilloid 1) receptor, the investigators will have established that mannitol down-regulates or blocks the TRPV1 (transient receptor potential vanilloid 1) receptor.
Read the detailed description
Capsaicin cream, which stimulates the TRPV1 (transient receptor potential vanilloid 1) receptor, causing a burning sensation, will be applied to both halves of the upper lip until a burning sensation with 8/10 intensity on an NRS (Visual Analog Scale) scale is experienced or five minutes have elapsed. Following this, the capsaicin cream will be wiped off and 30% mannitol in vehicle cream ( isopropyl palmitate, caprylic capric triglyceride, propylene glycol, ceteareth 20, cetearyl alcohol, glyceryl stearate, polyethylene glycol 100 stearate, dimethicone, octyldodecanol, lecithin, ethylhexyl glycerin and phenoxy ethanol) will be applied to one half of the upper lip, and vehicle cream alone will be applied to the other half. Cream assignment will be randomized and neither the subject nor the person applying the cream will know which half upper lip has which cream. Every minute for 10 minutes, the heat sensation felt in each half upper lip will be measured, using a visual scale from 0 to 10. A repeated measures analysis of variance will compare the NRS (Visual Analog Scale) scores from the 30% mannitol cream, to the NRS (Visual Analog Scale)scores from the vehicle cream. Significance will be accepted if P less than .05.
- Conditions
- Pain
- Being tested
- 30% Mannitol in vehicle cream, vehicle cream
- Keywords
- Mannitol, TRPV1 receptor, Pain, Burning pain, neuropathy, neuropathic pain
- Medical subject headings
- Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30% Mannitol in vehicle creamDrug
Also called mannitol cream, Mannitol, mannite, manna sugar
applied to one half of the upper lip following removal of capsaicin cream.
vehicle creamDrug
application to the other half of the upper lip following capsaicin cream removal
| Study group | Role | What they receive |
|---|---|---|
| Mannitol in vehicle cream | Active comparator | Once the capsaicin has been removed, .2 mL of 30% mannitol in vehicle cream will be applied to one half of the upper lip and kept there for 10 minutes. Receives: Drug: 30% Mannitol in vehicle cream |
| Vehicle Cream | Placebo comparator | Once the capsaicin has been removed, .2 mL of vehicle cream will be applied to the other half of the upper lip and kept there for 10 minutes. Receives: Drug: vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS heat score, once per minute
Every minute after capsaicin cream application, subject will indicate NRS (numerical rating scale)heat score. When the score has reached 8/10 or after five minutes, the cream will be removed. The time needed to reach 8/10 heat score and the heat score achieved, or the score at five minutes will be recorded. Following application of the test creams, NRS (Visual Analog Scale) heat scores will be recorded once per minute for each side for 10 minutes.
Measured: 15 minutes per subject
Secondary outcomes (1)
Side effects of capsaicin cream on upper lip
The subject will be observed for redness, swelling, or other side effects following the capsaicin cream application. These side effects will be recorded
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Bertrand, University of British Columbia
- Investigators
- Helene Bertrand, MD, CM, CCFP, Principal investigator, Department of family practice, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963910
- Sponsor's protocol ID
- H13-01551
- Acronym
- LipTRP
- Status last verified
- Feb 2014
- First submitted
- 10 Oct 2013
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ngom PI, Dubray C, Woda A, Dallel R. A human oral capsaicin pain model to assess topical anesthetic-analgesic drugs. Neurosci Lett. 2001 Dec 28;316(3):149-52. doi: 10.1016/s0304-3940(01)02401-6.
PubMed 11744224Boudreau SA, Wang K, Svensson P, Sessle BJ, Arendt-Nielsen L. Vascular and psychophysical effects of topical capsaicin application to orofacial tissues. J Orofac Pain. 2009 Summer;23(3):253-64.
PubMed 19639105Bertrand H, Kyriazis M, Reeves KD, Lyftogt J, Rabago D. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial. PM R. 2015 Nov;7(11):1111-1117. doi: 10.1016/j.pmrj.2015.05.002. Epub 2015 May 12.
PubMed 25978942
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream
- ClinicalTrials.gov ID
- NCT01963910
- Acronym / sponsor ID
- LipTRP / H13-01551
- Conditions
- Pain
- Keywords
- Mannitol, TRPV1 receptor, Pain, Burning pain, neuropathy, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Oct 2013 (estimated)
- 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.
Capsaicin is a TRPV1 (transient receptor potential vanilloid 1) agonist, causing pain upon application. The investigators wish to determine whether mannitol blocks the effect of capsaicin application. As both cream bases are identical and mannitol addition is the only difference between the creams, if the mannitol cream is more effective in blocking the effect of capsaicin on the TRPV1 (transient receptor potential vanilloid 1) receptor, the investigators will have established that mannitol down-regulates or blocks the TRPV1 (transient receptor potential vanilloid 1) receptor.
Detailed description
Capsaicin cream, which stimulates the TRPV1 (transient receptor potential vanilloid 1) receptor, causing a burning sensation, will be applied to both halves of the upper lip until a burning sensation with 8/10 intensity on an NRS (Visual Analog Scale) scale is experienced or five minutes have elapsed. Following this, the capsaicin cream will be wiped off and 30% mannitol in vehicle cream ( isopropyl palmitate, caprylic capric triglyceride, propylene glycol, ceteareth 20, cetearyl alcohol, glyceryl stearate, polyethylene glycol 100 stearate, dimethicone, octyldodecanol, lecithin, ethylhexyl glycerin and phenoxy ethanol) will be applied to one half of the upper lip, and vehicle cream alone will be applied to the other half. Cream assignment will be randomized and neither the subject nor the person applying the cream will know which half upper lip has which cream. Every minute for 10 minutes, the heat sensation felt in each half upper lip will be measured, using a visual scale from 0 to 10. A repeated measures analysis of variance will compare the NRS (Visual Analog Scale) scores from the 30% mannitol cream, to the NRS (Visual Analog Scale)scores from the vehicle cream. Significance will be accepted if P less than .05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannitol in vehicle cream | Active comparator | Drug: 30% Mannitol in vehicle creamOnce the capsaicin has been removed, .2 mL of 30% mannitol in vehicle cream will be applied to one half of the upper lip and kept there for 10 minutes. |
| Vehicle Cream | Placebo comparator | Drug: vehicle creamOnce the capsaicin has been removed, .2 mL of vehicle cream will be applied to the other half of the upper lip and kept there for 10 minutes. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 19 and 80 years
Key exclusion criteria (10 listed)
- Diet containing capsaicin (Cayenne pepper, capsicum) (spicy foods), more than once a week.
- Meal containing capsaicin (spicy foods) within 5 days prior to the experiment.
- Any lesion, cracking, cold sore or abrasion on the lips
- Inability to tolerate capsaicin containing "spicy foods"
- Wearing lipstick or lip balm on the upper lip
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 |
|---|---|---|
| 30% Mannitol in vehicle creamAlso: mannitol cream, Mannitol, mannite, manna sugarapplied to one half of the upper lip following removal of capsaicin cream. | Drug | Mannitol in vehicle cream |
| vehicle creamapplication to the other half of the upper lip following capsaicin cream removal | Drug | Vehicle Cream |
Primary outcome
NRS heat score, once per minute
Time frame: 15 minutes per subject
Every minute after capsaicin cream application, subject will indicate NRS (numerical rating scale)heat score. When the score has reached 8/10 or after five minutes, the cream will be removed. The time needed to reach 8/10 heat score and the heat score achieved, or the score at five minutes will be recorded. Following application of the test creams, NRS (Visual Analog Scale) heat scores will be recorded once per minute for each side for 10 minutes.
1 secondary outcome
Side effects of capsaicin cream on upper lip
Time frame: One hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Background: PubMed 11744224Ngom PI, Dubray C, Woda A, Dallel R. A human oral capsaicin pain model to assess topical anesthetic-analgesic drugs. Neurosci Lett. 2001 Dec 28;316(3):149-52. doi: 10.1016/s0304-3940(01)02401-6.
- Background: PubMed 19639105Boudreau SA, Wang K, Svensson P, Sessle BJ, Arendt-Nielsen L. Vascular and psychophysical effects of topical capsaicin application to orofacial tissues. J Orofac Pain. 2009 Summer;23(3):253-64.
- Derived from this study: PubMed 25978942Bertrand H, Kyriazis M, Reeves KD, Lyftogt J, Rabago D. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial. PM R. 2015 Nov;7(11):1111-1117. doi: 10.1016/j.pmrj.2015.05.002. Epub 2015 May 12.
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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.
Helene Bertrand, MD, CM, CCFP principal investigator
Department of family practice, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pain, run by University of British Columbia 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 4 Mar 2014. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NRS heat score, once per minute (time frame: 15 minutes per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963910, which also lists 3 linked publications.
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 Mar 2014.