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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30% Mannitol in vehicle cream | Drug | applied to one half of the upper lip following removal of capsaicin cream. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 minutes per subject |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One hour |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects of test creams | The subjects will be observed for side effects of the mannitol cream or the vehicle cream | one hour |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helene Bertrand, MD, CM, CCFP | Department of family practice, University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Helene Bertrand Inc., 220-1940 Lonsdale Ave. | North Vancouver | British Columbia | V7M 2K2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11744224 | Background | 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. | |
| 19639105 | Background | Boudreau 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| vehicle cream | Drug | application to the other half of the upper lip following capsaicin cream removal |
|
| 25978942 | Derived | Bertrand 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. |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |