An interventional study of 30% Mannitol in vehicle cream and vehicle cream in Pain, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 19 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-04.
Sponsored by University of British Columbia · Not applicable, Interventional, and Basic science
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.
University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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.
Drug: 30% Mannitol in vehicle cream
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.
Drug: vehicle cream
applied to one half of the upper lip following removal of capsaicin cream.
Also known as: mannitol cream, Mannitol, mannite, manna sugar, C6H8(OH)6
application to the other half of the upper lip following capsaicin cream removal
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.
Time frame: 15 minutes per subject
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
Time frame: One hour
Side effects of test creams
The subjects will be observed for side effects of the mannitol cream or the vehicle cream
Time frame: one hour
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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University of British Columbia