Vytorin in the Treatment of Alopecia Areata

University of Miami

Status and phase: Completed; Phase 1

Conditions: Alopecia Areata

Treatments: Drug: vytorin

Study type: Interventional

Funder types: Other

Identifiers

NCT01520077

eprost-20100451

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Vytorin

Other group

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.

Treatment:

Drug: vytorin