Vitiligo Clinical Trial
Official title:
Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial
Verified date | March 2017 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | December 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice | Nice | Alpes-Maritimes |
Indonesia | National Skin center - 1 Mandalay Rd | Bedok | Singapore |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France, Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) |
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