NCT02432534

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2015

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

April 10, 2015

Last Update Submit

March 20, 2026

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • VETF

    4 times (baseline, 1 month, 3 month and 6 month)

  • PGA

    4 times (baseline, 1 month, 3 month and 6 month)

  • Adverse event

    4 times (baseline, 1 month, 3 month and 6 month)

Study Arms (2)

UVB + treatement

EXPERIMENTAL

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

Drug: Atorvastatin

UVB

OTHER

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

Other: UVB

Interventions

AtorvastatinDRUG

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.

Also known as: UVB
UVB + treatement
UVBOTHER

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

UVB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Nice

Nice, Alpes-Maritimes, 06001, France

Location

National Skin center - 1 Mandalay Rd

Bedok, Singapore, 308205, Indonesia

Location

Related Publications (1)

  • 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.

    PMID: 29617528RESULT

MeSH Terms

Conditions

Vitiligo

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Passeron Thierry, PhD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

  • Chuah Sai Yee, Ph

    Singapour

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

May 4, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2017

Study Completion

December 1, 2017

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

FR(1)ID(1)