Vytorin in the Treatment of Alopecia Areata
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata|
- 20% Hair regrowth [ Time Frame: 6 months ] [ Designated as safety issue: No ]would like at least 20% regrowth within 6 months time.
- maintenance of hair [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
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.
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.
Other Name: Vytorin 10/40
To evaluate the efficacy of oral simvastatin + ezetimibe (Vytorin) in treating alopecia areata in subjects 18 years and older.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520077
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: marc handler, md 305-243-8485 firstname.lastname@example.org|
|Sub-Investigator: marc handler, md|
|Principal Investigator:||Lawrence Schachner, M.D||University of Miami|