VitiligoPhase 2Rapid VitiligoNCT03036995
Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO
A Phase 2 study testing Apremilast in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an acquired pigmentary disorder of the skin and mucous membranes that is characterized by circumscribed, depigmented macules and patches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2017to 25 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of non-segmental vitiligo affecting at least 10% of BSA since at least 3 months.
- Patient requiring a treatment by UVB
- For both female of childbearing potential and male patients: Use of an effective contraceptive method during the study period (see Annex 5 for details)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
- Able to adhere to the study visit schedule and other protocol requirements
- Patient registered to the French Social Security
Who cannot join
- Segmental or mixed vitiligo
- Other than vitiligo, history of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
- Any condition which would place the subject at unacceptable risk if he/she were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
- Pregnant or breast feeding, pregnancy urinary tests will be performed (see Annex 5 for details about pregnancy testing and contraception)
- History of allergy to any component of apremilast
Show all 21Show fewer
- History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
- Active substance abuse or a history of substance abuse within 6 months prior to Screening
- Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening.
- Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence)
- Evidence of skin conditions that would interfere with clinical assessments
- Topical therapy within 2 weeks of randomization
- Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
- Prior treatment with apremilast
- Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives,
- Patients assessed to be uncooperative
- Participants in other clinical studies
- Vulnerable people: pregnant or breast-feeding women (an urinary pregnancy test will be realized in every visit), minors, adults under guardianship or guardianship, deprived of freedom
- Patient with a rare hereditary disease such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
- Patient with severe renal insufficiency
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Nice - Dermatologie - Hôpital Archet
Nice, Alpes-Maritimes, 06
About this study
Official title: Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO RAPID VITILIGO
Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an acquired pigmentary disorder of the skin and mucous membranes that is characterized by circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4) inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and psoriasis. Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading to anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes. Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for promoting melanogenesis and for inducing the differentiation and the proliferation of melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo. Patients with non-segmental vitiligo with BSA > 10% and patient with Vitiligo stable or slowly progressive for 3 months , seeking for treatment in the Department of Dermatology, University Hospital of Nice, France will be recruited into the study. The Patients are seen in consultation by the investigator, selection criteria are checked. All patients will receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks.
From W24 to W48
Read more
- All responders* will receive narrow UVB treatment according the French clinical use i.e.twice weekly sessions of narrowband UVB for 24 weeks.
- All responders* will be randomized to receive either apremilast** 30mg BID or placebo.
- Response is defined as an increase of at least 30 % in the VASI score at W24 compare to baseline **Responders initially randomized in the placebo arm will benefit of the titration At week 24, the non responders patients will stop the treatment and the study after the 4 weeks observationnal follow-up (W28).
Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all subjects who complete the study (responders and non responders) or discontinue the study early.
- Conditions
- Vitiligo
- Being tested
- Apremilast, Placebo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Patient will receive narrow UVB treatment and apremilast (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and apremilast during 24 weeks.
PlaceboOther
Patient will receive narrow UVB treatment and placebo (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and placebo during 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Apremilast - Group A | Experimental | Patient will receive narrow UVB treatment and apremilast (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and apremilast during 24 weeks. Receives: Drug: Apremilast |
| Placebo - Group B | Placebo comparator | Patient will receive UVB treatment and placebo (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment and placebo during 24 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score VASI
Efficacy will be evaluated using the Vitiligo Area Scoring Index (VASI)
Measured: at 24 weeks
Secondary outcomes (2)
Score VETF
Efficacity will be also evaluated using the Vitiligo European Task Score (VETF)
Measured: at 24 weeks
Score VE
Efficacy will be also evaluated using the Vitiligo Extent Score (VES)
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start20 Mar 2017
- Primary completion8 Nov 2018
- Study completion25 Nov 2019
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 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 Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036995
- Sponsor's protocol ID
- 16-PP-06
- Acronym
- Rapid Vitiligo
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2017
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khemis A, Fontas E, Moulin S, Montaudie H, Lacour JP, Passeron T. Apremilast in Combination with Narrowband UVB in the Treatment of Vitiligo: A 52-Week Monocentric Prospective Randomized Placebo-Controlled Study. J Invest Dermatol. 2020 Aug;140(8):1533-1537.e2. doi: 10.1016/j.jid.2019.11.031. Epub 2020 Jan 29.
PubMed 32004567
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
- Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO RAPID VITILIGO
- ClinicalTrials.gov ID
- NCT03036995
- Acronym / sponsor ID
- Rapid Vitiligo / 16-PP-06
- Conditions
- Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 31 Jan 2017 (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.
Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an acquired pigmentary disorder of the skin and mucous membranes that is characterized by circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4) inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and psoriasis. Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading to anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes. Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for promoting melanogenesis and for inducing the differentiation and the proliferation of melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo. Patients with non-segmental vitiligo with BSA > 10% and patient with Vitiligo stable or slowly progressive for 3 months , seeking for treatment in the Department of Dermatology, University Hospital of Nice, France will be recruited into the study. The Patients are seen in consultation by the investigator, selection criteria are checked. All patients will receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks.
From W24 to W48
- All responders* will receive narrow UVB treatment according the French clinical use i.e.twice weekly sessions of narrowband UVB for 24 weeks.
- All responders* will be randomized to receive either apremilast** 30mg BID or placebo.
- Response is defined as an increase of at least 30 % in the VASI score at W24 compare to baseline **Responders initially randomized in the placebo arm will benefit of the titration At week 24, the non responders patients will stop the treatment and the study after the 4 weeks observationnal follow-up (W28).
Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all subjects who complete the study (responders and non responders) or discontinue the study early.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast - Group A | Experimental | Drug: ApremilastPatient will receive narrow UVB treatment and apremilast (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and apremilast during 24 weeks. |
| Placebo - Group B | Placebo comparator | Other: PlaceboPatient will receive UVB treatment and placebo (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment and placebo during 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of non-segmental vitiligo affecting at least 10% of BSA since at least 3 months.
- Patient requiring a treatment by UVB
- For both female of childbearing potential and male patients: Use of an effective contraceptive method during the study period (see Annex 5 for details)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
- Able to adhere to the study visit schedule and other protocol requirements
Key exclusion criteria (21 listed)
- Segmental or mixed vitiligo
- Other than vitiligo, history of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
- Any condition which would place the subject at unacceptable risk if he/she were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
- Pregnant or breast feeding, pregnancy urinary tests will be performed (see Annex 5 for details about pregnancy testing and contraception)
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 |
|---|---|---|
| ApremilastPatient will receive narrow UVB treatment and apremilast (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and apremilast during 24 weeks. | Drug | Apremilast - Group A |
| PlaceboPatient will receive narrow UVB treatment and placebo (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and placebo during 24 weeks. | Other | Placebo - Group B |
Primary outcome
Score VASI
Time frame: at 24 weeks
Efficacy will be evaluated using the Vitiligo Area Scoring Index (VASI)
2 secondary outcomes
Score VETF
Time frame: at 24 weeks
Score VE
Time frame: at 24 weeks
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 32004567Khemis A, Fontas E, Moulin S, Montaudie H, Lacour JP, Passeron T. Apremilast in Combination with Narrowband UVB in the Treatment of Vitiligo: A 52-Week Monocentric Prospective Randomized Placebo-Controlled Study. J Invest Dermatol. 2020 Aug;140(8):1533-1537.e2. doi: 10.1016/j.jid.2019.11.031. Epub 2020 Jan 29.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 21 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 1 site in France. 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. Some participants in this study may receive a placebo. 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?
Score VASI (time frame: at 24 weeks). 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 NCT03036995, 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.