Atorvastatin in Active Vitiligo

Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Atorvastatin; Other: UVB

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • CHU de Nice
• Indonesia
  • Singapore
    • Bedok, Singapore, Indonesia, 308205
      • National Skin center - 1 Mandalay Rd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UVB + treatement; The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months.	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 Names: UVB
Other: UVB; The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.	Other: UVB; The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of decrease in Vitiligo Area Scoring Index (VASI) score	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.	4 times (baseline, 1 month, 3 month and 6 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VETF	Percentage of decrease in Vitiligo European Task Score (VETF) score between baseline and 6 months after commencement of the study.	4 times (baseline, 1 month, 3 month and 6 month)
PGA	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.	4 times (baseline, 1 month, 3 month and 6 month)
Adverse event	Description of potential side effects using clinical evaluation and biology. Clinical and biological tolerability of high dose of oral atorvastatin will be recorded.	4 times (baseline, 1 month, 3 month and 6 month)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Passeron Thierry, PhD, Centre Hospitalier Universitaire de Nice; Principal Investigator: Chuah Sai Yee, Ph, Singapour

Publications and helpful links

General Publications

• Nguyen S, Chuah SY, Fontas E, Khemis A, Jhingan A, Thng STG, Passeron T. Atorvastatin in Combination With Narrowband UV-B in Adult Patients With Active Vitiligo: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jun 1;154(6):725-726. doi: 10.1001/jamadermatol.2017.6401.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimated): May 4, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Pyrroles; Heptanoic Acids; Atorvastatin
• Other Study ID Numbers: 15-AOI-01