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Vytorin in the Treatment of Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520077
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Dr. Lawrence Schachner, University of Miami

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: vytorin Phase 1

Detailed Description:

Primary objective:

To evaluate the efficacy of oral simvastatin + ezetimibe (Vytorin) in treating alopecia areata in subjects 18 years and older.

Secondary objective:

To investigate the presence of heat shock proteins in alopecia areata subjects, before and after treatment with oral simvastatin.

Subjects will be asked to take vytorin 10/40 for a period of 24 or 52 weeks and monitored for progression of hair regrowth. They will have Lipids, creatinine kinase (CK), liver function tests (LFTs), obtained on baseline visit prior to starting the medication and at visit 2, week 8. LFTs will be continuously monitored at visit 4, 7, week 24 and week 40.

In case of muscular pain or tenderness the medication will be stopped immediately. In most cases, muscle symptoms and CK increases resolved when simvastatin treatment was promptly discontinued.

All adverse events will be recorded

The investigators are going to exclude:

oChildren less than 18 years

  • Pregnant women
  • Lactating women
  • Subjects with kidney, liver or muscle disease
  • Allergy to the drug or its components. Subjects with history of uncontrolled hypothyroidism, The investigators Hypothesize that this medication may have an effect on the inflammatory process of alopecia areata. Inactivating the inflammatory cascade may help in permitting hair regrowth in those subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata
Study Start Date : July 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment

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
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.
Other Name: Vytorin 10/40

Primary Outcome Measures :
  1. 20% Hair regrowth [ Time Frame: 6 months ]
    would like at least 20% regrowth within 6 months time.

Secondary Outcome Measures :
  1. maintenance of hair [ Time Frame: 6 months ]
    Will monitor patients from week 25-52 who have had 20% hairgrowth by week 24 and determine if without the medication if they continue to have hairgrowth, remain stable or lose hair.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 40-80% hair loss.
  • Clinical diagnosis of alopecia areata
  • 18-years or older

Exclusion Criteria:

  1. You are less than 18 years old
  2. You are pregnant or planning to be pregnant during the next 12 months.
  3. You are nursing a child.
  4. You have kidney, liver or muscle disease.
  5. You have an allergy to Lidocaine, the study drug or its components.
  6. You are presently participating in another clinical trial
  7. 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).
  8. You are currently using, or have used within the past 2 weeks, any topical medication for the treatment of alopecia areata
  9. You have an ongoing hypothyroid problem that is not being treated. If this problem is being treated then you can participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01520077

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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Principal Investigator: Lawrence Schachner, M.D University of Miami

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Responsible Party: Dr. Lawrence Schachner, Chairman of department of Dermatology & Cutaneous Surgery, University of Miami Identifier: NCT01520077    
Other Study ID Numbers: eprost-20100451
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Dr. Lawrence Schachner, University of Miami:
alopecia areata
hair growth
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents