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Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream

Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: 30% Mannitol in vehicle cream (Drug); vehicle cream (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of British Columbia

Official(s) and/or principal investigator(s):
Helene Bertrand, MD, CM, CCFP, Principal Investigator, Affiliation: Department of family practice, University of British Columbia

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.

Clinical Details

Official title: Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: NRS heat score, once per minute

Secondary outcome: Side effects of capsaicin cream on upper lip

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.

Eligibility

Minimum age: 19 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age between 19 and 80 years

Exclusion Criteria:

- 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

- 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

Locations and Contacts

Dr. Helene Bertrand Inc., 220-1940 Lonsdale Ave., North Vancouver, British Columbia V7M 2K2, Canada
Additional Information

Related 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.

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.

Starting date: December 2013
Last updated: February 28, 2014

Page last updated: August 23, 2015

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