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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gil Yosipovitch, Wake Forest University
ClinicalTrials.gov Identifier:
NCT00655811
First received: April 4, 2008
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Capsaicin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • To assess ethnic differences in burning pain induced by topical capsaicin [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess ethnic differences on the effects of topical capsaicin on thermal sensory thermal thresholds [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2008
Study Completion Date: October 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Capsaicin
Capsaicin 0.1% cream application to the volar side of forearm.
Drug: Capsaicin
Topical application

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655811

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Gil Yosipovitch, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Gil Yosipovitch, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT00655811     History of Changes
Other Study ID Numbers: 00003739
Study First Received: April 4, 2008
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Healthy volunteers

Additional relevant MeSH terms:
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2014