Response of Topical Capsaicin in Alopecia Areata - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 8, 2006

Start Date ^ICMJE

August 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00176969 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The scalps of AA patients may be less sensitive to stimuli.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Response of Topical Capsaicin in Alopecia Areata

Official Title ^ICMJE

Perifollicular Nerves in Alopecia Areata: Response to Topical Capsaicin

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Alopecia Areata

Intervention ^ICMJE

Drug: Capsaicin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00176969

Responsible Party

Study ID Numbers ^ICMJE

9707M00122

Study Sponsor ^ICMJE

Hordinsky, Maria K., MD

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Maria Hordinsky, MD	University of Minnesota
Principal Investigator:	Marna Ericson, Ph D	University of Minnesota

Information Provided By

University of Minnesota

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP