NCT00176969

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 1997

Typical duration for phase_4

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

August 1, 1997

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

First QC Date

September 12, 2005

Last Update Submit

May 30, 2014

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

CapsaicinDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • Maria Hordinsky, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Marna Ericson, Ph D

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 1997

Study Completion

June 1, 2000

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

US(1)