Atorvastatin in Active Vitiligo

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 2

Conditions: Vitiligo

Treatments: Other: UVB; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02432534

15-AOI-01

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

UVB + treatement

Experimental group

Description:

The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months.

Treatment:

Drug: Atorvastatin

UVB

Other group

Description:

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

Treatment:

Other: UVB