NCT01520077

Vytorin in the Treatment of Alopecia Areata

A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	vytorin	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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-01-27
• Last updated: 2015-03-17

Locations

1 site across 1 country: United States