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

Pain Clinical Trial

— LipTRP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963910
• Other study ID #: H13-01551
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: February 28, 2014
• Start date: December 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 30% Mannitol in vehicle cream
applied to one half of the upper lip following removal of capsaicin cream.
• vehicle cream
application to the other half of the upper lip following capsaicin cream removal

Locations

Country	Name	City	State
Canada	Dr. Helene Bertrand Inc., 220-1940 Lonsdale Ave.	North Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects of test creams	The subjects will be observed for side effects of the mannitol cream or the vehicle cream	one hour	Yes
Primary	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	No
Secondary	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	Yes