Alopecia Areata | Vytorin in the Treatment of Alopecia Areata
Alopecia Areata research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:vytorinPatient 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
VytorinSubjects 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.
Start Date: July 2011
Completed Date: January 2015
Phase: Phase 1
Primary Outcome: 20% Hair regrowth
Secondary Outcome: maintenance of hair
Study sponsors, principal investigator, and references
Principal Investigator: Lawrence Schachner, M.D
Lead Sponsor: University of Miami
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.