Atorvastatin in Active Vitiligo

Study Overview
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Brief Summary
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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.

Official Title
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Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Atorvastatin
* Other: UVB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UVB + treatement<br>The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months. | Drug: Atorvastatin<br>* 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.<br>* Other names: UVB;|
| Other: UVB<br>The patients will be receiving only NB-UVB phototherapy twice a week for 6 months. | Other: UVB<br>* The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of decrease in Vitiligo Area Scoring Index (VASI) score | 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. | 4 times (baseline, 1 month, 3 month and 6 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VETF | Percentage of decrease in Vitiligo European Task Score (VETF) score between baseline and 6 months after commencement of the study. | 4 times (baseline, 1 month, 3 month and 6 month) | 
| PGA | 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. | 4 times (baseline, 1 month, 3 month and 6 month) | 
| Adverse event | Description of potential side effects using clinical evaluation and biology. Clinical and biological tolerability of high dose of oral atorvastatin will be recorded. | 4 times (baseline, 1 month, 3 month and 6 month) |