A Phase 1 interventional study of Capsaicin 0.1% and Placebo in Pain, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 39 Years and older. Per ClinicalTrials.gov, last updated 2013-06-21.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Supportive care
This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the body; counts of which are used to determine a disease of nerves called "small nerve fiber neuropathy."
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.
On the first day, two areas of the skin of the subject's right abdomen will be marked and identified as sites A and B. Each day for one week the subject will be asked to grade her degree of discomfort or pain from 1 to 10 at sites marked A and B every two hours beginning at 8 a.m. and ending at 10 p.m.
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capsaicin cream 0.1% will be applied to site A or B on the subject's abdomen daily for 7 days.
Drug: Capsaicin 0.1%
The placebo cream will be applied to site A or B on the subject's abdomen daily for 7 days.
Drug: Placebo
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
Also known as: Capzacin
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
Burning pain as measured by a numeric rating scale of 1-10
Time frame: 1 week
Tactile hyperalgesia as measured with monofilaments A, B, C, (through I), ranging in providing forces -3, -2, -1 (through +5) In grams
This outcome measure consists of touch pressure testing of tactile hyperalgesia (increased sensitivity to pain) with monofilaments consists of recognizing the lowest level at which the subject can feel the touch of a monofilament hair, and to the point of discomfort or pain. The units for tactile hyperalgesia are In grams of touch pressure.
Time frame: 1 week
Thermal hyperalgesia as measured by the heat as pain thermode test using CASE IVc
This outcome measure tests heat-pain sensation (the lowest degree of a thermal warming pulse that the subject can perceive as discomfort or pain). CASE IVc is a computerized quantitative sensation testing instrument, extensively described. It was originally developed at Mayo Clinic and the Section of Engineering. It is now manufactured by WR Medical Electronics in Maplewood, Minnesota. This instrument provides exponentially increasing pyramidal and trapezoid heat pulses to a maximum of 49 degrees centigrade for 10 seconds.
Time frame: 1 week
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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