Vytorin in the Treatment of Alopecia Areata

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Lawrence Schachner, University of Miami
ClinicalTrials.gov Identifier:
NCT01520077
First received: January 24, 2012
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Alopecia Areata
Drug: vytorin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 20% Hair regrowth [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    would like at least 20% regrowth within 6 months time.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No medication
After 24 weeks those who have had 20% hair growth will be randomized to continue to receive the medication or be monitored while not receiving the medication.
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.
Other Name: Vytorin 10/40
Active Comparator: Vytorin
Patients will receive 10/40mg tablets daily for 52 weeks.
Drug: vytorin
Daily taking vytorin 10/40mg for 52 weeks by mouth.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520077

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: marc handler, md    305-243-8485    mhandler@med.miami.edu   
Sub-Investigator: marc handler, md         
Sponsors and Collaborators
University of Miami
  More Information

Publications:
Responsible Party: Dr. Lawrence Schachner, Chairman of department of Dermatology & Cutaneous Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT01520077     History of Changes
Other Study ID Numbers: eprost-20100451
Study First Received: January 24, 2012
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
alopecia areata
vytorin
statin
hair growth

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014