Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
This study has been completed.
Information provided by (Responsible Party):
Gil Yosipovitch, Wake Forest University
First received: April 4, 2008
Last updated: December 18, 2012
Last verified: December 2012
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2008 (Final data collection date for primary outcome measure)
Active Comparator: Capsaicin
Capsaicin 0.1% cream application to the volar side of forearm.
To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|Wake Forest University Health Sciences Dermatology
|Winston Salem, North Carolina, United States, 27157 |
Wake Forest School of Medicine
||Gil Yosipovitch, MD
||Wake Forest School of Medicine
No publications provided
||Gil Yosipovitch, Professor, Wake Forest University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 4, 2008
||December 18, 2012
||United States: Institutional Review Board
Keywords provided by Wake Forest School of Medicine:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents