Alopecia AreataPhase 4NCT00176969
Response of Topical Capsaicin in Alopecia Areata
A Phase 4 study testing Capsaicin in people with Alopecia Areata, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Capsaicin
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1997to Jun 2000
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the 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.
- Conditions
- Alopecia Areata
- Being tested
- Capsaicin
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 1997
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Hordinsky, MD, Principal investigator, University of MinnesotaMarna Ericson, Ph D, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176969
- Sponsor's protocol ID
- 9707M00122
- Status last verified
- May 2014
- First submitted
- 12 Sep 2005
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perifollicular Nerves in Alopecia Areata: Response to Topical Capsaicin
- ClinicalTrials.gov ID
- NCT00176969
- Acronym / sponsor ID
- 9707M00122
- Conditions
- Alopecia Areata
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 1997
- Study completion
- Jun 2000
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Absence of extensive alopecia areata.
- People not in good health.
- People taking medications.
- Allergies to capsaicin.
- Presence of irritated or visibly inflamed scalp.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin | Drug | – |
Primary outcome
Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.
1 secondary outcome
The scalps of AA patients may be less sensitive to stimuli.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Hordinsky, MD principal investigator
University of Minnesota
Marna Ericson, Ph D principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Capsaicin in people with Alopecia Areata, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.