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

Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Capsaicin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Gil Yosipovitch, MD, Principal Investigator, Affiliation: Wake Forest School of Medicine

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: To assess ethnic differences in burning pain induced by topical capsaicin

Secondary outcome: To assess ethnic differences on the effects of topical capsaicin on thermal sensory thermal thresholds

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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Wake Forest University Health Sciences Dermatology, Winston Salem, North Carolina 27157, United States
Additional Information

Starting date: February 2008
Last updated: December 18, 2012

Page last updated: August 20, 2015

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