Atorvastatin in Active Vitiligo
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atorvastatin
UVB
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo
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
Sites / Locations
- CHU de Nice
- National Skin center - 1 Mandalay Rd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
UVB + treatement
UVB
Arm Description
The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months.
The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
VETF
Percentage of decrease in Vitiligo European Task Score (VETF) score between baseline and 6 months after commencement of the study.
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.
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.
Full Information
NCT ID
NCT02432534
First Posted
April 10, 2015
Last Updated
February 1, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02432534
Brief Title
Atorvastatin in Active Vitiligo
Official Title
Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UVB + treatement
Arm Type
Experimental
Arm Description
The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months.
Arm Title
UVB
Arm Type
Other
Arm Description
The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
UVB
Intervention Description
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
Other
Intervention Name(s)
UVB
Intervention Description
The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.
Primary Outcome Measure Information:
Title
Percentage of decrease in Vitiligo Area Scoring Index (VASI) score
Description
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.
Time Frame
4 times (baseline, 1 month, 3 month and 6 month)
Secondary Outcome Measure Information:
Title
VETF
Description
Percentage of decrease in Vitiligo European Task Score (VETF) score between baseline and 6 months after commencement of the study.
Time Frame
4 times (baseline, 1 month, 3 month and 6 month)
Title
PGA
Description
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.
Time Frame
4 times (baseline, 1 month, 3 month and 6 month)
Title
Adverse event
Description
Description of potential side effects using clinical evaluation and biology. Clinical and biological tolerability of high dose of oral atorvastatin will be recorded.
Time Frame
4 times (baseline, 1 month, 3 month and 6 month)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chuah Sai Yee, Ph
Organizational Affiliation
Singapour
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France
Facility Name
National Skin center - 1 Mandalay Rd
City
Bedok
State/Province
Singapore
ZIP/Postal Code
308205
Country
Indonesia
12. IPD Sharing Statement
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Atorvastatin in Active Vitiligo
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