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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsaicin | Active Comparator | Capsaicin 0.1% cream application to the volar side of forearm. |
|
| Placebo moisturizing cream | Placebo Comparator | Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) to the opposite forearm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Drug | Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gil Yosipovitch, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Capsaicin and Placebo | 0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm. A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capsaicin and Placebo | 0.1% Topical Capsaicin cream was appled to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm. A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | 1 day |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capsaicin | 0.1% Topical Capsaicin cream was applied to one forearm. A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gil Yosipovitch, MD, Professor | University of Miami | 305-243-5121 | gyosipovitch@med.miami.edu |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Placebo moisturizing cream | Drug | Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) |
|
|
| 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. | 1 day |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Caucasians | 0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm. A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application. |
| OG002 | East Asians | 0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm. A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application. |
| OG003 | Hispanics | 0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm. A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Change in degrees Celsius | 1 day |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 day |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | A placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm. A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application. | 0 | 40 | 0 | 40 |
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| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| Warmth sensation threshold change |
|
| Superiority |
| t-test, 2 sided | 0.002 | Superiority |