HealthyPhase 4NCT00655811
Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
A Phase 4 study testing Capsaicin in people with Healthy, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27157
About this study
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.
Read the detailed description
To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.
- Conditions
- Healthy
- Being tested
- Capsaicin, Placebo moisturizing cream
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Also called Topical capsaicin, 0.1%, Capzasin HP
Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A
Placebo moisturizing creamDrug
Also called Cetaphil
Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Active comparator | Capsaicin 0.1% cream application to the volar side of forearm. Receives: Drug: Capsaicin |
| 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. Receives: Drug: Placebo moisturizing cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gil Yosipovitch, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655811
- Sponsor's protocol ID
- 00003739
- Status last verified
- Aug 2018
- First submitted
- 4 Apr 2008
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
- ClinicalTrials.gov ID
- NCT00655811
- Acronym / sponsor ID
- 00003739
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Posted 14 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Active comparator | Drug: CapsaicinCapsaicin 0.1% cream application to the volar side of forearm. |
| Placebo moisturizing cream | Placebo comparator | Drug: Placebo moisturizing creamPlacebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) to the opposite forearm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsaicinAlso: Topical capsaicin, 0.1%, Capzasin HPTopical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A | Drug | Capsaicin |
| Placebo moisturizing creamAlso: CetaphilPlacebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) | Drug | Placebo moisturizing cream |
Primary outcome
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.
2 secondary outcomes
Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds
Time frame: 1 day
The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application.
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil Yosipovitch, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Capsaicin in people with Healthy, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ethnic Differences in Burning Pain Induced by Topical Capsaicin (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.