VitiligoPhase 2NCT02432534
Atorvastatin in Active Vitiligo
A Phase 2 study testing Atorvastatin and UVB in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Atorvastatin and UVB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Indonesia1 site
National Skin center - 1 Mandalay Rd
Bedok, Singapore, 308205
About this study
Official title: Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial
Condition:
Non segmental and active vitiligo of adulthood.
Read more
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.
- Conditions
- Vitiligo
- Being tested
- Atorvastatin, UVB
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called UVB
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.
UVBOther
The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| UVB + treatement | Experimental | The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months. Receives: Drug: Atorvastatin |
| UVB | Other | The patients will be receiving only NB-UVB phototherapy twice a week for 6 months. Receives: Other: UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 times (baseline, 1 month, 3 month and 6 month)
Secondary outcomes (3)
VETF
Percentage of decrease in Vitiligo European Task Score (VETF) score between baseline and 6 months after commencement of the study.
Measured: 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.
Measured: 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.
Measured: 4 times (baseline, 1 month, 3 month and 6 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passeron Thierry, PhD, Principal investigator, Centre Hospitalier Universitaire de NiceChuah Sai Yee, Ph, Principal investigator, Singapour
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432534
- Sponsor's protocol ID
- 15-AOI-01
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2015
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29617528
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02432534
- Acronym / sponsor ID
- 15-AOI-01
- Conditions
- Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UVB + treatement | Experimental | Drug: AtorvastatinThe patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months. |
| UVB | Other | Other: UVBThe patients will be receiving only NB-UVB phototherapy twice a week for 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Active non-segmental vitiligo defined by
- Patient requiring a treatment by UVB
- Signed informed consent document
- Patient registered to the French Social Security
Key exclusion criteria (17 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: UVBThe 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. | Drug | UVB + treatement |
| UVBThe patients will be receiving only NB-UVB phototherapy twice a week for 6 months. | Other | UVB |
Primary outcome
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.
3 secondary outcomes
VETF
Time frame: 4 times (baseline, 1 month, 3 month and 6 month)
PGA
Time frame: 4 times (baseline, 1 month, 3 month and 6 month)
Adverse event
Time frame: 4 times (baseline, 1 month, 3 month and 6 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 29617528Nguyen 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.
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
Not yet recruitingPhase 3
A Study to Learn How Effective, Safe, and Tolerable Upadacitinib is for Young Participants With Non-segmental Vitiligo
Non-Segmental Vitiligo
Active, not recruitingPhase 1
A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
Vitiligo
Active, not recruitingPhase 3
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Stable Nonsegmental Vitiligo, Active Nonsegmental Vitiligo
RecruitingPhase 2
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Non-segmental Vitiligo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Passeron Thierry, PhD principal investigator
Centre Hospitalier Universitaire de Nice
Chuah Sai Yee, Ph principal investigator
Singapour
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin and UVB in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of decrease in Vitiligo Area Scoring Index (VASI) score (time frame: 4 times (baseline, 1 month, 3 month and 6 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.