Atorvastatin in Active Vitiligo

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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