NCT01520077

Brief Summary

Subjects, non pregnant/lactating and over 18years old, with 40% alopecia areata will take vytorin (statin/ezetimibe) for 24 or 52 weeks and be monitored for hair regrowth. The investigators hypothesize that Vytorin medication may have an effect on the inflammatory process of alopecia areata. Inactivating the inflammatory process may help in permitting hair regrowth in those subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2011

Typical duration for phase_1

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

July 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.5 years

First QC Date

January 24, 2012

Last Update Submit

March 16, 2015

Conditions

Alopecia Areata

Keywords

alopecia areatavytorinstatinhair growth

Outcome Measures

Primary Outcomes (1)

  • 20% Hair regrowth

    would like at least 20% regrowth within 6 months time.

    6 months

Secondary Outcomes (1)

  • maintenance of hair

    6 months

Study Arms (1)

Vytorin

OTHER

Subjects will receive Vytorin for 24 weeks. At 24 weeks if regrowth greater or equal than 20%, subjects will be randomized 1/1 to either stop or continue vytorin. Subjects will be follow for additional 24 weeks. Subjects that at 24 weeks don't meet the 20% regrowth will be dropped out of the study.

Drug: vytorin

Interventions

vytorinDRUG

Patient will take once per day by mouth Vytorin 10/40mg. Will take it for 24 weeks and then continue or discontinue treatment at that time and be monitored for 24 more weeks. Should there be no improvement by the initial 24 weeks then they will no longer be in the study.

Also known as: Vytorin 10/40
Vytorin

Eligibility Criteria

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

You may qualify if:

  • % hair loss.
  • Clinical diagnosis of alopecia areata
  • years or older

You may not qualify if:

  • You are less than 18 years old
  • You are pregnant or planning to be pregnant during the next 12 months.
  • You are nursing a child.
  • You have kidney, liver or muscle disease.
  • You have an allergy to Lidocaine, the study drug or its components.
  • You are presently participating in another clinical trial
  • You are currently using, or have used within the past 3 months, the following:
  • Systemic corticosteroids. (prednisone, methylprednisolone, hydrocortisone etc.)
  • Immunosuppressant agents.(cyclosporine, efalizumab etc.)
  • Any medication that may have interaction with Vytorin (check with the study doctor for other medications you are taking).
  • You are currently using, or have used within the past 2 weeks, any topical medication for the treatment of alopecia areata
  • You have an ongoing hypothyroid problem that is not being treated. If this problem is being treated then you can participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Ali A, Martin JM 4th. Hair growth in patients alopecia areata totalis after treatment with simvastatin and ezetimibe. J Drugs Dermatol. 2010 Jan;9(1):62-4.

    PMID: 20120427BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SimvastatinLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEzetimibeAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Lawrence Schachner, M.D

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of department of Dermatology & Cutaneous Surgery

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 27, 2012

Study Start

July 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(1)