Back to resultsResponse of Topical Capsaicin in Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Capsaicin
Sponsored by
About this trial
This is an interventional diagnostic trial for Alopecia Areata
Eligibility Criteria
Inclusion Criteria: Must have alopecia totalis or universalis. Be in good health. Not be taking any medications including topical medications Be 18 years or older. Be willing to apply study medication or vehicle as directed, comply with instructions and commit to follow-up visits. Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study. Exclusion Criteria: Absence of extensive alopecia areata. People not in good health. People taking medications. Allergies to capsaicin. Presence of irritated or visibly inflamed scalp. Having had hair chemically treated (including colored hair, permed hair, etc.) within the month prior to study.
Sites / Locations
- University of Minnesota
Outcomes
Primary Outcome Measures
Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.
Secondary Outcome Measures
The scalps of AA patients may be less sensitive to stimuli.
Full Information
NCT ID
NCT00176969
First Posted
September 12, 2005
Last Updated
May 30, 2014
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT00176969
Brief Title
Response of Topical Capsaicin in Alopecia Areata
Official Title
Perifollicular Nerves in Alopecia Areata: Response to Topical Capsaicin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It has been postulated that Alopecia Areata (AA) is, at least in part, a neurologically mediated disease. Research supporting this theory includes the finding that nerves surrounding the hair follicles are collapsed. We want to take this research a step further and show that not only are these perifollicular nerves collapsed, but that their function is also impaired.
Detailed Description
To assess the function of perifollicular scalp nerves in AA we will look at the response of these nerves to the topical medication capsaicin. Under normal circumstances topical capsaicin is known to target nerves in the peripheral nervous system causing short-term release of the neuropeptide Substance P (SP) as well as long-term transient depletion of SP. We expect the AA patients will respond abnormally to topical capsaicin treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Primary Outcome Measure Information:
Title
Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.
Secondary Outcome Measure Information:
Title
The scalps of AA patients may be less sensitive to stimuli.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must have alopecia totalis or universalis.
Be in good health.
Not be taking any medications including topical medications
Be 18 years or older.
Be willing to apply study medication or vehicle as directed, comply with instructions and commit to follow-up visits.
Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study.
Exclusion Criteria:
Absence of extensive alopecia areata.
People not in good health.
People taking medications.
Allergies to capsaicin.
Presence of irritated or visibly inflamed scalp.
Having had hair chemically treated (including colored hair, permed hair, etc.) within the month prior to study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marna Ericson, Ph D
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Response of Topical Capsaicin in Alopecia Areata
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