A Phase 4 interventional study of Capsaicin and Placebo moisturizing cream in Healthy, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Wake Forest University · Phase 4, Interventional, and Basic science
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.
To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.
Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capsaicin 0.1% cream application to the volar side of forearm.
Drug: Capsaicin
Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) to the opposite forearm.
Drug: Placebo moisturizing cream
Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A
Also known as: Topical capsaicin, 0.1%, Capzasin HP
Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
Also known as: Cetaphil
Ethnic Differences in Burning Pain Induced by Topical Capsaicin
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 burning or pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable pain sensation). The subjects were also asked to indicate whether they experienced any nonpainful sensation.
Time frame: 1 day
Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds
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 12 cm2. The probe warmed the skin surface at a linear rate of 0·4 °C per second, up to a cut-off of 50 °C. Thermal thresholds were measured in the following order: warmth sensation threshold was measured followed by heat pain detection threshold; each of them was determined four times by the ascending method of limits.
Time frame: 1 day
The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application.
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 intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable burning/pain sensation). The subjects were also asked to indicate whether they experienced any non-burning/-painful sensation.
Time frame: 1 day
| Milestone | Capsaicin and Placebo |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
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 burning or pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable pain sensation). The subjects were also asked to indicate whether they experienced any nonpainful sensation.
| units on a scale | African Americans | Caucasians | East Asians | Hispanics |
|---|---|---|---|---|
| Capsaicin | 0.81 ± 0.68 | 4.07 ± 1.61 | 17.05 ± 5.80 | 13.3 ± 4.67 |
| Placebo | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
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 12 cm2. The probe warmed the skin surface at a linear rate of 0·4 °C per second, up to a cut-off of 50 °C. Thermal thresholds were measured in the following order: warmth sensation threshold was measured followed by heat pain detection threshold; each of them was determined four times by the ascending method of limits.
| Change in degrees Celsius | African Americans | Caucasians | East Asians | Hispanics |
|---|---|---|---|---|
| Heat pain detection threshold change | -2.11 ± 1.12 | -6.10 ± 1.36 | -5.01 ± 1.09 | -7.24 ± 0.57 |
| Warmth sensation threshold change | 2.36 ± 0.93 | -0.68 ± 0.68 | 0.56 ± .059 | -3.15 ± 0.93 |
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 intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable burning/pain sensation). The subjects were also asked to indicate whether they experienced any non-burning/-painful sensation.
| units on a scale | Capsaicin | Placebo |
|---|---|---|
| The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application. | 8.81 ± 7.63 | 0 ± 0 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Capsaicin | — | 0/40 (0%) | 0/40 (0%) |
| Placebo | — | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | Capsaicin and Placebo |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 40 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Capsaicin and Placebo |
|---|---|
| Female | 20 |
| Male | 20 |
| Race/Ethnicity, Customized(Participants) | Capsaicin and Placebo |
|---|---|
| African Americans | 10 |
| Caucasians | 10 |
| East Asians | 10 |
| Hispanic | 10 |
| Region of Enrollment(Participants) | Capsaicin and Placebo |
|---|---|
| United States | 40 |
Plan to share: No
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Wake Forest University