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Completed

NCT Number: NCT02432534

Atorvastatin in Active Vitiligo

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Nice, Nice, Alpes-Maritimes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

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 names: UVB

UVB

Other

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

Primary outcomes

  1. Percentage of decrease in Vitiligo Area Scoring Index (VASI) score

    Time frame: 4 times (baseline, 1 month, 3 month and 6 month)

    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.

Secondary outcomes

  1. VETF

    Time frame: 4 times (baseline, 1 month, 3 month and 6 month)

    Percentage of decrease in Vitiligo European Task Score (VETF) score between baseline and 6 months after commencement of the study.

  2. PGA

    Time frame: 4 times (baseline, 1 month, 3 month and 6 month)

    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.

  3. Adverse event

    Time frame: 4 times (baseline, 1 month, 3 month and 6 month)

    Description of potential side effects using clinical evaluation and biology. Clinical and biological tolerability of high dose of oral atorvastatin will be recorded.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 4, 2015
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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