Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
|ClinicalTrials.gov Identifier: NCT00655811|
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : August 14, 2017
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Capsaicin Drug: Placebo moisturizing cream||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects|
|Study Start Date :||February 2008|
|Primary Completion Date :||August 2008|
|Study Completion Date :||October 2009|
Active Comparator: Capsaicin
Capsaicin 0.1% cream application to the volar side of forearm.
Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A
Other Name: Topical capsaicin, 0.1%, Capzasin HP
Placebo Comparator: Placebo moisturizing cream
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
Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
Other Name: Cetaphil
- Ethnic Differences in Burning Pain Induced by Topical Capsaicin [ 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.
- Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds [ 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.
- The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application. [ 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655811
|United States, North Carolina|
|Wake Forest University Health Sciences Dermatology|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Gil Yosipovitch, MD||Wake Forest University Health Sciences|