Clinical trial NCT02432534: Atorvastatin in Active Vitiligo
Official title: Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitiligo
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of decrease in Vitiligo Area Scoring Index (VASI) score
timeFrame: 4 times (baseline, 1 month, 3 month and 6 month)
Secondary outcomes:
measure: VETF
timeFrame: 4 times (baseline, 1 month, 3 month and 6 month)
measure: PGA
timeFrame: 4 times (baseline, 1 month, 3 month and 6 month)
measure: Adverse event
timeFrame: 4 times (baseline, 1 month, 3 month and 6 month)
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes-Maritimes
city: Bedok
country: Indonesia
facility: National Skin center - 1 Mandalay Rd
state: Singapore
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Passeron Thierry, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapour
name: Chuah Sai Yee, Ph
role: PRINCIPAL_INVESTIGATOR
References: