View Clinical Trial (Medical Research Study)
A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata
| City: |
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Miami |
| State: |
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Florida |
| Zip Code: |
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33136 |
| Conditions: |
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Alopecia Areata |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01520077 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Miami, Florida 33136
United States
marc handler, md
Phone: 305-243-8485
Email: mhandler@med.miami.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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