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Vytorin in the Treatment of Alopecia Areata

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ClinicalTrials.gov Identifier: NCT01520077
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Lawrence Schachner, University of Miami

January 24, 2012
January 27, 2012
March 17, 2015
July 2011
January 2015   (Final data collection date for primary outcome measure)
20% Hair regrowth [ Time Frame: 6 months ]
would like at least 20% regrowth within 6 months time.
Same as current
Complete list of historical versions of study NCT01520077 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Vytorin in the Treatment of Alopecia Areata
A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata

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.

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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alopecia Areata
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
Vytorin

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.

Intervention: Drug: vytorin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
30
January 2015
January 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01520077
eprost-20100451
Yes
Not Provided
Not Provided
Dr. Lawrence Schachner, University of Miami
University of Miami
Not Provided
Principal Investigator: Lawrence Schachner, M.D University of Miami
University of Miami
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP