Ignite Creation Date:
2024-05-06 @ 2:05 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01963910
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2013-10-10
Brief Title:
Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LipTRP
Brief 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 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 810 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 Scalescores from the vehicle cream Significance will be accepted if P less than 05
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None