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

NCT01963910 | Completed

• 1 other identifier: H13-01551
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Mannitol; TRPV1 receptor; Pain; Burning pain; neuropathy; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Side effects of capsaicin cream on upper lip

  One hour

Other Outcomes (1)

• Side effects of test creams

  one hour

Study Arms (2)

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.

Drug: 30% Mannitol in vehicle cream

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.

Drug: vehicle cream

Interventions

30% Mannitol in vehicle cream DRUG

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

Mannitol in vehicle cream

vehicle cream DRUG

application to the other half of the upper lip following capsaicin cream removal

Vehicle Cream

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 19 and 80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Dr. Helene Bertrand Inc., 220-1940 Lonsdale Ave.

North Vancouver, British Columbia, V7M 2K2, Canada

Location

Related Publications (3)

• 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.

  PMID: 11744224 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.

  PMID: 19639105 BACKGROUND

• 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.

  PMID: 25978942 DERIVED

MeSH Terms

Conditions

Pain; Neuralgia

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Helene Bertrand, MD, CM, CCFP

  Department of family practice, University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical instructor Department of Family Practice

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 16, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 4, 2014

Record last verified: 2014-02

Locations

CA (1)