- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00176969
Response of Topical Capsaicin in Alopecia Areata
May 30, 2014 updated by: University of Minnesota
Perifollicular Nerves in Alopecia Areata: Response to Topical Capsaicin
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.
Study Overview
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.
Study Type
Interventional
Enrollment
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.
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Secondary Outcome Measures
Outcome Measure |
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The scalps of AA patients may be less sensitive to stimuli.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marna Ericson, Ph D, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1997
Study Completion
June 1, 2000
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
June 2, 2014
Last Update Submitted That Met QC Criteria
May 30, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9707M00122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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