Expired Study
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Winston-Salem, North Carolina 27157


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.


Study summary:

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


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.


Study is Available At:


Original ID:

00003739


NCT ID:

NCT00655811


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wake Forest University Health Sciences


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gil Yosipovitch, MD
Principal Investigator
Wake Forest University Health Sciences

Study Dates

Start Date:February 2008
Completion Date:October 2009
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 9, 2018
First Received Date:April 4, 2008
First Results Date:March 16, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application.
Time Frame:1 day
Safety Issues:False
Description:This secondary outcome is to see if subjects rated burning/pain differently between the topical capsaicin or placebo application. Participants will rate burning/pain intensity after topical capsaicin and placebo application. The burning/pain sensation int
Outcome Type:Secondary Outcome
Measure:Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds
Time Frame:1 day
Safety Issues:False
Description:A secondary endpoint is to see if topical capsaicin has an effect on warm and heat pain thresholds. Quantitative thermosensory testing was carried out using the Medoc TSA 2001 (Medoc Ltd). The probe baseline temperature was 32 °C and the contact area was
Outcome Type:Primary Outcome
Measure:Ethnic Differences in Burning Pain Induced by Topical Capsaicin
Time Frame:1 day
Safety Issues:False
Description: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 b

Study Interventions

Intervention Type:Drug
Name:Capsaicin
Description:Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A
Arm Name:Capsaicin
Other Name:Topical capsaicin, 0.1%, Capzasin HP
Intervention Type:Drug
Name:Placebo moisturizing cream
Description:Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
Arm Name:Placebo moisturizing cream
Other Name:Cetaphil

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo moisturizing cream
Description:Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) to the opposite forearm.
Study Arm Type:Active Comparator
Arm Name:Capsaicin
Description:Capsaicin 0.1% cream application to the volar side of forearm.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wake Forest University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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