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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVB + treatement | Experimental | The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months. |
|
| UVB | Other | The patients will be receiving only NB-UVB phototherapy twice a week for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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. |
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Inclusion Criteria:
Active non-segmental vitiligo defined by
Patient requiring a treatment by UVB
Signed informed consent document
Patient registered to the French Social Security
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Passeron Thierry, PhD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Chuah Sai Yee, Ph | Singapour | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Nice | Alpes-Maritimes | 06001 | France | ||
| National Skin center - 1 Mandalay Rd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29617528 | Result | 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. |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| UVB | Other | The patients will be receiving only NB-UVB phototherapy twice a week for 6 months. |
|
| 4 times (baseline, 1 month, 3 month and 6 month) |
| 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) |
| Bedok |
| Singapore |
| 308205 |
| Indonesia |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |