Clinical trial NCT01520077: Vytorin in the Treatment of Alopecia Areata
Official title: A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alopecia Areata
Keywords: alopecia areata
vytorin
statin
hair growth
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 20% Hair regrowth
timeFrame: 6 months
Secondary outcomes:
measure: maintenance of hair
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Lawrence Schachner, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.