Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects

NCT00655811 | Completed Phase 4 Results

• 1 other identifier: 00003739
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study how people respond differently to capsaicin in different racial groups and the effect it has on your pain levels. Capsaicin is a natural product made from hot chili peppers that is useful for treating the itch symptoms of skin disease.

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Ethnic Differences in Burning Pain Induced by Topical Capsaicin

  The primary endpoint is to test the burning pain effect of topical capsaicin by using an continuous visual analog scale (CoVAS) intensity scale as an outcome measure. Participants will rate burning pain intensity after topical capsaicin application. The burning or pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable pain sensation). The subjects were also asked to indicate whether they experienced any nonpainful sensation.

  1 day

Secondary Outcomes (2)

• Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds

  1 day

• The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application.

  1 day

Study Arms (2)

Capsaicin

ACTIVE COMPARATOR

Capsaicin 0.1% cream application to the volar side of forearm.

Drug: Capsaicin

Placebo moisturizing cream

PLACEBO COMPARATOR

Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) to the opposite forearm.

Drug: Placebo moisturizing cream

Interventions

Capsaicin DRUG

Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A

Also known as: Topical capsaicin, 0.1%, Capzasin HP

Capsaicin

Placebo moisturizing cream DRUG

Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)

Also known as: Cetaphil

Placebo moisturizing cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult men and women who are between 18 and 50 years of age.
• Subjects must be in general good health with no skin disease, disease state or physical condition which would impair evaluation of pain perception or which would increase their health risk by study participation as determined by the investigators.
• Women of childbearing potential will be required to have a negative pregnancy test in order to enroll in the study.

You may not qualify if:

• Adults over age 50.
• Children less than 18 years of age.
• Unable to complete the required measures.
• Diagnosis of diseases that would affect the measurement of pain perception.
• Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 30 days prior to study participation.
• Use of oral analgesic or other medications known to interfere with pain perception in the week prior to the study.
• Use of emollient on the forearms on the day of the study visit.
• Use of medicated topical preparations on the forearms for the week prior to the study.
• Known history of neuropathy causing diseases such as uremia.
• Known history of uncontrolled thyroid disease.
• Known history of diabetes mellitus.
• Allergy to capsaicin.
• Pregnant women.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Capsaicin; cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Gil Yosipovitch, MD, Professor
• Organization: University of Miami

gyosipovitch@med.miami.edu

305-243-5121

Study Officials

• Gil Yosipovitch, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2009
• Last Updated: September 10, 2018
• Results First Posted: August 14, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)