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The Effect of Ablation of Epidermal Nerve Fibers Using Capsaicin Cream

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883102
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Peter J. Dyck, M.D., Mayo Clinic

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain Drug: Capsaicin 0.1% Drug: Placebo Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Ablation of Epidermal Nerve Fibers Using 0.1% Capsaicin Cream on Spontaneous Cutaneous Burning Pain, Tactile Hyperalgesia, and Thermal Hyperalgesia: A Controlled, Masked Trial With an N of 1
Study Start Date : June 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Capsaicin 0.1%
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%
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
Other Name: Capzacin

Placebo Comparator: 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.
Drug: Placebo
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.




Primary Outcome Measures :
  1. Burning pain as measured by a numeric rating scale of 1-10 [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Tactile hyperalgesia as measured with monofilaments A, B, C, (through I), ranging in providing forces -3, -2, -1 (through +5) In grams [ Time Frame: 1 week ]

    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.


  2. Thermal hyperalgesia as measured by the heat as pain thermode test using CASE IVc [ Time Frame: 1 week ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   39 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pain syndrome
  • must be able to be in study for one week

Exclusion Criteria:

- not able to be in study for one week


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883102


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Peter Dyck, MD Mayo Clinic
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Responsible Party: Peter J. Dyck, M.D., MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01883102    
Other Study ID Numbers: 13-002235
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs