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Atorvastatin in Active Vitiligo

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ClinicalTrials.gov Identifier: NCT02432534
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE April 10, 2015
First Posted Date  ICMJE May 4, 2015
Last Update Posted Date February 5, 2018
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
Percentage of decrease in Vitiligo Area Scoring Index (VASI) score [ Time Frame: 4 times (baseline, 1 month, 3 month and 6 month) ]
Percentage of decrease in Vitiligo Area Scoring Index (VASI) score between baseline and 6 months after commencement of the study. In the VASI assessment, the body is separated into five sites: hands, upper extremities, trunk, lower extremities and feet. The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. The VASI score is then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the surface of the lesions of all body sites together.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
  • VETF [ Time Frame: 4 times (baseline, 1 month, 3 month and 6 month) ]
    Percentage of decrease in Vitiligo European Task Score (VETF) score between baseline and 6 months after commencement of the study.
  • PGA [ Time Frame: 4 times (baseline, 1 month, 3 month and 6 month) ]
    Physician global assessment (PGA). Treatment response will be graded as excellent (76 - 100%), moderate (51 - 75%), Mild (26 - 50%), minimal (1 - 25%) or no response.
  • Adverse event [ Time Frame: 4 times (baseline, 1 month, 3 month and 6 month) ]
    Description of potential side effects using clinical evaluation and biology. Clinical and biological tolerability of high dose of oral atorvastatin will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atorvastatin in Active Vitiligo
Official Title  ICMJE Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial
Brief Summary

Condition:

Non segmental and active vitiligo of adulthood.

Main objective:

To evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to UVB compared to UVB alone in active vitiligo after 6 months of treatment.

Methods:

Prospective interventional bicentric study with evaluation blinded to the treatment received.

Inclusion criteria:

Patients from 18 to 75 year-old with active non segmental vitiligo. Active is defined by the apparition or the modification of vitiligo lesions with the past 3 months and under Wood's lamp examination hypochromic borders and/or spotty depigmentation.

Interventions:

After central randomization

  • Arm A : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice weekly narrowband UVB treatment for 6 months.
  • Arm B: with twice weekly narrowband UVB treatment for 6 months.

Evaluation:

Main criteria: Decrease of VASI score expressed in percentage Secondary criteria: Decrease of VETF score expressed in percentage. Variation of PGA and DLQI scores. Clinical and biological tolerance. Variation of CXCL10 levels in the serum.

Length of the study:

Inclusion period: 12 months. Length of treatment: 6 months. Statistical analyses and drafting the article: 6 months. Total length: 24 months.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vitiligo
Intervention  ICMJE
  • Drug: Atorvastatin
    The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months. The initial starting dose of the oral atorvastatin will be 40mg daily and after 1 month, if tolerated clinically and biologically following blood tests, the dose will be increased to 80mg daily.
    Other Name: UVB
  • Other: UVB
    The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.
Study Arms  ICMJE
  • Experimental: UVB + treatement
    The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months.
    Intervention: Drug: Atorvastatin
  • UVB
    The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.
    Intervention: Other: UVB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2015)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active non-segmental vitiligo defined by

    • Non- segmental vitiligo with new patches or extension of old lesions during the last 3 months AND
    • Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination
  • Patient requiring a treatment by UVB
  • Signed informed consent document
  • Patient registered to the French Social Security

Exclusion Criteria:

  • - Segmental or mixed vitiligo
  • Pregnant (urinary pregnancy test will be done) or lactating patients
  • Allergy to statin medications
  • Use of statin or fibrate medications due to cardiac risks
  • Use of statin medications in the past 8 weeks
  • Use of any medications contraindicated with use of statin medications
  • Use of vitiligo treatments (both topicals and phototherapy) in the past 4 weeks
  • Treatment with immunomodulating oral medications in the past 4 weeks
  • Hepatic disease and/or dysfunction
  • Renal dysfunction
  • Personal or familial history of myopathy or personal history of rhabdomyolysis or elevated baseline creatinine kinase
  • Alcohol or drug abuse
  • Untreated hypothyroidism
  • Personal history of skin cancer
  • Any other clinically significant findings that, in the opinion of the Principal Investigator, might interfere with study evaluations or pose a risk to subject safety during the study.
  • Patients assessed to be uncooperative
  • Participants in other clinical studies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02432534
Other Study ID Numbers  ICMJE 15-AOI-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Passeron Thierry, PhD Centre Hospitalier Universitaire de Nice
Principal Investigator: Chuah Sai Yee, Ph Singapour
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP