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

NCT ID: NCT00655811

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-10-31

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.

Detailed Description

To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Capsaicin

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

Group Type: ACTIVE_COMPARATOR

Capsaicin

Intervention Type: DRUG

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

Placebo moisturizing cream

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

Group Type: PLACEBO_COMPARATOR

Placebo moisturizing cream

Intervention Type: DRUG

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

Interventions

Capsaicin

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

Intervention Type: DRUG

Placebo moisturizing cream

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

Intervention Type: DRUG

Other Intervention Names

Topical capsaicin, 0.1%, Capzasin HP; Cetaphil

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gil Yosipovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

00003739

Identifier Type: -

Identifier Source: org_study_id