Phase 4
Completed N=40
Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT00655811 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Ethnic Differences in Burning Pain Induced by Topical Capsaicin — 0.81; 4.07; 17.05; 13.3 units on a scale — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ethnic Differences in Burning Pain Induced by Topical Capsaicin |
0.81; 4.07; 17.05; 13.3; 0; 0 | <0.05 sig |
| SECONDARY Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds |
-2.11; -6.10; -5.01; -7.24; 2.36; -0.68 | 0.012 sig |
| SECONDARY The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application. |
8.81; 0 | 0.06 |
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.
Data sourced from ClinicalTrials.gov (NCT00655811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.