Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT00655811
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 4
Winston-Salem, North Carolina, 27157, United States
To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A
Other names: Topical capsaicin, 0.1%, Capzasin HP
Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
Other names: Cetaphil
Time frame: 1 day
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
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
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.
Wake Forest University
Other
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