drugset / Trial / NCT02432534

Atorvastatin in Active Vitiligo

NCT02432534

Phase 2 Completed 28 enrolled Centre Hospitalier Universitaire de Nice
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-05
Primary completion
2017-02
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 80 mg Oral

Indications