Atorvastatin in Active Vitiligo

NCT ID: NCT02432534

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UVB + treatement

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

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: 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.

UVB

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

Group Type: OTHER

UVB

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

UVB

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

Intervention Type: OTHER

Other Intervention Names

UVB

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Passeron Thierry, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Chuah Sai Yee, Ph

Role: PRINCIPAL_INVESTIGATOR

Singapour

Locations

CHU de Nice

Nice, Alpes-Maritimes, France

National Skin center - 1 Mandalay Rd

Bedok, Singapore, Indonesia

Countries

France; Indonesia

Other Identifiers

15-AOI-01

Identifier Type: -

Identifier Source: org_study_id