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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: vytorin

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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 Names: Vytorin 10/40

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
20% Hair regrowth	would like at least 20% regrowth within 6 months time.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maintenance of hair	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.	6 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Lawrence Schachner, M.D, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: hair growth; statin; alopecia areata; vytorin
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe, Simvastatin Drug Combination
• Other Study ID Numbers: eprost-20100451