Vytorin in the Treatment of Alopecia Areata

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Brief Title

Vytorin in the Treatment of Alopecia Areata

Official Title

A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata

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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

20% Hair regrowth

Secondary Outcome

 maintenance of hair

Condition

Alopecia Areata

Intervention

vytorin

Study Arms / Comparison Groups

 Vytorin
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

29

Start Date

July 2011

Completion Date

January 2015

Primary Completion Date

January 2015

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lawrence Schachner, M.D, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01520077

Organization ID

eprost-20100451


Responsible Party

Principal Investigator

Study Sponsor

University of Miami


Study Sponsor

Lawrence Schachner, M.D, Principal Investigator, University of Miami


Verification Date

March 2015