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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01520077 |
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Date of registration:
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24/01/2012 |
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Primary sponsor: |
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Public title:
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Vytorin in the Treatment of Alopecia Areata
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Scientific title:
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A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01520077 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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marc handler, md |
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Address:
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Telephone:
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305-243-8485 |
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Email:
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mhandler@med.miami.edu |
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Affiliation:
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alopecia Areata
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Intervention(s)
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Drug: vytorin
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Primary Outcome(s)
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20% Hair regrowth
[Time Frame: 6 months]
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Secondary Outcome(s)
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maintenance of hair
[Time Frame: 6 months]
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Secondary ID(s)
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eprost-20100451
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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