Clinical Trial of Simvastatin to Treat Generalized Vitiligo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Harris, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01517893
First received: January 13, 2012
Last updated: March 10, 2015
Last verified: March 2015
Results First Received: February 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Vitiligo
Interventions: Drug: Simvastatin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intervention Arm

Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated

Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated

Placebo Arm Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated

Participant Flow:   Overall Study
    Intervention Arm     Placebo Arm  
STARTED     8     7  
COMPLETED     6     6  
NOT COMPLETED     2     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Arm

Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated

Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated

Placebo Arm Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
Total Total of all reporting groups

Baseline Measures
    Intervention Arm     Placebo Arm     Total  
Number of Participants  
[units: participants]
  8     7     15  
Age  
[units: years]
Mean ( Full Range )
  43.9  
  ( 28 to 55 )  
  39  
  ( 32 to 49 )  
  41.6  
  ( 28 to 55 )  
Gender  
[units: participants]
     
Female     0     0     0  
Male     8     7     15  
Vitiligo area scoring index [1]
[units: percentage]
Mean ( Full Range )
  14.81  
  ( 3.23 to 40.93 )  
  23.09  
  ( 5.12 to 46.26 )  
  19.23  
  ( 3.23 to 46.26 )  
[1] The vitiligo area scoring index (VASI) is a measure of the surface area affected by vitiligo in a given research subject. It ranges from 0% (no vitiligo) to 100% (complete depigmentation of the entire body surface area). In terms of treatment, a decrease in VASI is desirable as it indicates less surface area affected by vitiligo. The score represents an estimate made by the investigators, based on the approximation that one "hand unit," is roughly equivalent to 1% of the body surface area.



  Outcome Measures

1.  Primary:   Decrease in VASI Score   [ Time Frame: Assessed at final study visit, 6 months after randomization ]

2.  Secondary:   Increase in Investigator's Global Assessment Score   [ Time Frame: Assessed at final study visit, 6 months after randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Safety and Tolerability of High-dose Simvastatin Use in Vitiligo Patients.   [ Time Frame: Assessed at every visit following randomization (monthly for 6 months) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Decrease in Sentinel Patch Area   [ Time Frame: Assessed at final study visit, 6 months after randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Increase in Quality of Life (QoL) Score   [ Time Frame: Assessed at final study visit, 6 months after randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Decrease in CXCR3 Expression on CD8+ T Cells   [ Time Frame: Assessed prior to treatment and periodically while on treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Increase in Patient's Global Assessment Score   [ Time Frame: Assessed at final study visit, 6 months after randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Correlation Among Various Outcome Measures for Vitiligo   [ Time Frame: Assessed at final study visit, 6 months after randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Decrease in Serum Chemokines   [ Time Frame: Assessed prior to treatment and periodically while on treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John E. Harris, MD, PhD
Organization: University of Massachusetts Medical School
phone: 508-856-1982
e-mail: john.harris@umassmed.edu


No publications provided


Responsible Party: John Harris, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01517893     History of Changes
Other Study ID Numbers: UM-DERM001
Study First Received: January 13, 2012
Results First Received: February 19, 2015
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration