NCT01883102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

Same day

First QC Date

June 6, 2013

Last Update Submit

June 19, 2013

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Burning pain as measured by a numeric rating scale of 1-10

    1 week

Secondary Outcomes (2)

  • Tactile hyperalgesia as measured with monofilaments A, B, C, (through I), ranging in providing forces -3, -2, -1 (through +5) In grams

    1 week

  • Thermal hyperalgesia as measured by the heat as pain thermode test using CASE IVc

    1 week

Study Arms (2)

Capsaicin 0.1%

EXPERIMENTAL

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%

Placebo/cream without 0.1% capsaicin

PLACEBO COMPARATOR

The placebo cream will be applied to site A or B on the subject's abdomen daily for 7 days.

Drug: Placebo

Interventions

Capsaicin 0.1%DRUG

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

Also known as: Capzacin
Capsaicin 0.1%
PlaceboDRUG

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

Placebo/cream without 0.1% capsaicin

Eligibility Criteria

Age39 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- not able to be in study for one week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Dyck, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

US(1)