Vytorin in the Treatment of Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520077
• Other study ID #: eprost-20100451
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2012
• Last updated: March 16, 2015
• Start date: July 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20% Hair regrowth	would like at least 20% regrowth within 6 months time.	6 months	No
Secondary	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	No