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Atorvastatin in Active Vitiligo

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ClinicalTrials.gov Identifier: NCT02432534
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.


Condition or disease Intervention/treatment Phase
Vitiligo Drug: Atorvastatin Other: UVB Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial
Actual Study Start Date : May 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : December 2017


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 Name: UVB

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432534


Locations
France
CHU de Nice
Nice, Alpes-Maritimes, France, 06001
Indonesia
National Skin center - 1 Mandalay Rd
Bedok, Singapore, Indonesia, 308205
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Passeron Thierry, PhD CHU de Nice
Principal Investigator: Chuah Sai Yee, Ph Singapour

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02432534     History of Changes
Other Study ID Numbers: 15-AOI-01
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: March 2017

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors