The Effect of Ablation of Epidermal Nerve Fibers Using Capsaicin Cream
NCT ID: NCT01883102
Last Updated: 2013-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
1 participants
INTERVENTIONAL
2013-06-30
2013-06-30
Brief Summary
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Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1% capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such ablation results in relief of spontaneous pain, touch, or heat-pain.
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Detailed Description
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Each day except for Saturday and Sunday touch-pressure sensation will be evaluated using monofilaments and heat pain sensation at sites A and B. Also evaluated will be touch pressure pain at each of these sites.
On Thursday of the first week 3 mm punch biopsies of the skin will be obtained from sites A and B and another 3 mm punch biopsy will be obtained on Thursday of the following week from sites A and B.
Following the first biopsy, the experimental creams will be applied to sites A and B. One of the experimental creams contains 0.1% Capsaisin in a bland cream. The second cream contains no Capsaisin. 0.1% Capsaisin is known to destroy the small fibers, especially pain fibers in the skin. Both the investigators applying the cream and the subject will not know which experimental cream contains the Capsaisin. The creams will be applied on Thursday of the first week but only after all testing and skin biopsies have been done. The creams will be left in place except when testing is being done, and they will not be applied after the second set of skin biopsies has been obtained.
The creams will be applied by the investigators and by the subject, care being taken so that the tube marked A is applied to the site marked A, and the tube marked B is applied to the site marked B. Between application to the two sites, investigators and the subject will use different gloves and applicators, carefully washing their hands with soap and water between and after applications.
The subject will be asked not to shower or to immerse herself in water but to use sponge baths, avoiding the tested areas, so that the cream does not move to other areas.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Capsaicin 0.1%
Capsaicin cream 0.1% will be applied to site A or B on the subject's abdomen daily for 7 days.
Capsaicin 0.1%
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
Placebo/cream without 0.1% capsaicin
The placebo cream will be applied to site A or B on the subject's abdomen daily for 7 days.
Placebo
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
Interventions
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Capsaicin 0.1%
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
Placebo
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* must be able to be in study for one week
Exclusion Criteria
39 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Peter J. Dyck, M.D.
MD
Principal Investigators
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Peter Dyck, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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13-002235
Identifier Type: -
Identifier Source: org_study_id
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