Response of Topical Capsaicin in Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

Perifollicular Nerves in Alopecia Areata: Response to Topical Capsaicin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00176969
• Other study ID #: 9707M00122
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: May 30, 2014
• Start date: August 1997
• Est. completion date: June 2000

Study information

• Verified date: May 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Capsaicin

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.
Secondary	The scalps of AA patients may be less sensitive to stimuli.