Clinical Trial: Vytorin in the Treatment of Alopecia Areata

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: University of Miami

Current Primary Outcome: 20% Hair regrowth [ Time Frame: 6 months ]

would like at least 20% regrowth within 6 months time.


Original Primary Outcome: Same as current

Current Secondary Outcome: maintenance of hair [ Time Frame: 6 months ]

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.


Original Secondary Outcome: Same as current

Information By: University of Miami

Dates:
Date Received: January 24, 2012
Date Started: July 2011
Date Completion:
Last Updated: March 16, 2015
Last Verified: March 2015