NCT02432534

Atorvastatin in Active Vitiligo

Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitiligo

Interventions

Type	Name	Description
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	UVB	The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-02-01
• Completion: 2017-12-01
• First posted: 2015-05-04
• Last updated: 2026-03-24

Locations

2 sites across 2 countries: France, Indonesia