Vytorin in the Treatment of Alopecia Areata

Sponsor

University of Miami (Other)

Overall Status

Completed

CT.gov ID

NCT01520077

Collaborator

(none)

Enrollment

Location

Arm

42.1

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

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 :

Jul 1, 2011

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

maintenance of hair [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.