VitiligoPhase 3VITACNCT02466997
Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC
A Phase 3 study testing tacrolimus in people with Vitiligo, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
Multicentric French parallel double-blind randomized versus placebo study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- tacrolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Feb 2016to 30 Sep 2018
- Phase
- Phase 3
- 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
- Subject male or female with age over 18 years old
- Diagnosis of non-segmental (symmetrical) vitiligo
- Presence of at least one vitiligo target-plaque on the face, with:
- Area greater than 3cm² Local Vitiligo Area Severity Index (VASI) score ≥ 50% Stable (no change in pigmentation or size over the last 3 months) Recent onset (less than 2 years duration)
- Subject affiliated to the French social security system
Who cannot join
- Progressive vitiligo over the last 3 months
- Spontaneous ongoing repigmentation (documented in the last 3 months)
- Previous topical Tacrolimus treatment in the last 3 months
- Previous topical or systemic treatment in the last month:
- Topical or oral corticosteroid Topical vitamin D Phototherapy or laser Other topical treatment specific to vitiligo Other immunosuppressant or immunomodulator
- Underlying dermatological disease (i.e.: history of atopic dermatitis, eczema, psoriasis), which, according to the investigator, could interfere with the study assessments
Show all 12Show fewer
- Known sensitivity to study drug or macrolides
- Past history of skin cancer or lymphoma
- Congenital or acquired immunodeficiency
- Pregnant or breastfeeding women
- Women without contraception
- Absence of signed informed consent
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital of Bordeaux - St André Hospital
Bordeaux, 33000
Regional Hospital Center of Le Mans -
Le Mans, 72000
University Hospital Center of Nice - Hôpital de l'Archet
Nice, 06000
University Hospital Center of Rennes - Hôpital Pontchaillou
Rennes, 35000
About this study
Official title: Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study
Multicentric French parallel double-blind randomized versus placebo study
Read the detailed description
Multicentric French parallel double-blind randomized versus placebo study, with duration of treatment of 6 months, and a post-treatment follow-up period of 6 months
- Conditions
- Vitiligo
- Being tested
- tacrolimus, Placebo
- Keywords
- Vitiligo, Tacrolimus, Face
- Medical subject headings
- Vitiligo, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Protopic
tacrolimus 0.1% ointment applied twice a day for the experimental group during 24 weeks placebo ointment applied twice a day for the control group during 24 weeks
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus group | Experimental | Target-lesion will be treated with the study treatment BID. The batch of treatment (Tacrolimus ointment 0.1% or placebo) will be randomized. All the patients will be treated during 6 months. Counselling on natural daylight exposition will also be given to all patients. During the 6-month observation period, relapse (worsening of VASI ≥ 25%) will be re-treated by the study treatment Receives: Drug: tacrolimus |
| Control group | Placebo comparator | In the Control group, patients will receive the placebo ointment to be applied twice a day during 24 weeks.
Counselling on natural light exposure during the duration of the trial will be given. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of repigmented surface area of the target lesion ≥75%
To test the efficacy of a 24 weeks months Tacrolimus 0.1% ointment treatment vs placebo in an adult population with stable non-segmental vitiligo of the face. Therapeutic success is defined as the variation in percentage of repigmented surface area of the target lesion ≥75% at 24 weeks months.
Measured: One year
Secondary outcomes (10)
Variation in percentage of repigmented surface area
Variation in percentage of repigmented surface area of the target lesion between week 24 and week 48 (observation period) in patients who were successfully treated (observation period)
Measured: 24 weeks
Variation in percentage of repigmented surface area
Variation in percentage of repigmented surface area of the target lesion between week 24 and week 48 (observation period) in patients who were successfully treated (observation period)
Measured: 48 weeks
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
Measured: 12 weeks
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
Measured: 24 weeks
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
Measured: 48 weeks
Variation of the physician global evaluation of treatment efficacy
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit
Measured: 12 weeks
Variation of the physician global evaluation of treatment efficacy
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.
Measured: 24 weeks
Variation of the physician global evaluation of treatment efficacy
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.
Measured: 48 weeks
Variation of the Dermatology Life Quality Index
Variation of the Dermatology Life Quality Index (DLQI) between inclusion and after 24 weeks of treatment between the 2 groups
Measured: 24 weeks
Number of participants with Adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start23 Feb 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
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.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled EZZEDINE, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466997
- Sponsor's protocol ID
- CHUBX 2012/05
- Acronym
- VITAC
- Status last verified
- Apr 2021
- First submitted
- 26 May 2015
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taieb A, Ezzedine K. Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study. J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.
PubMed 33549606
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT02466997
- Acronym / sponsor ID
- VITAC / CHUBX 2012/05
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Tacrolimus, Face
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 9 Jun 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.
Multicentric French parallel double-blind randomized versus placebo study
Detailed description
Multicentric French parallel double-blind randomized versus placebo study, with duration of treatment of 6 months, and a post-treatment follow-up period of 6 months
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 |
|---|---|---|
| Tacrolimus group | Experimental | Drug: tacrolimusTarget-lesion will be treated with the study treatment BID. The batch of treatment (Tacrolimus ointment 0.1% or placebo) will be randomized. All the patients will be treated during 6 months. Counselling on natural daylight exposition will also be given to all patients. During the 6-month observation period, relapse (worsening of VASI ≥ 25%) will be re-treated by the study treatment |
| Control group | Placebo comparator | Drug: PlaceboIn the Control group, patients will receive the placebo ointment to be applied twice a day during 24 weeks. Counselling on natural light exposure during the duration of the trial will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject male or female with age over 18 years old
- Diagnosis of non-segmental (symmetrical) vitiligo
- Presence of at least one vitiligo target-plaque on the face, with:
- Area greater than 3cm² Local Vitiligo Area Severity Index (VASI) score ≥ 50% Stable (no change in pigmentation or size over the last 3 months) Recent onset (less than 2 years duration)
- Subject affiliated to the French social security system
Key exclusion criteria (12 listed)
- Progressive vitiligo over the last 3 months
- Spontaneous ongoing repigmentation (documented in the last 3 months)
- Previous topical Tacrolimus treatment in the last 3 months
- Previous topical or systemic treatment in the last month:
- Topical or oral corticosteroid Topical vitamin D Phototherapy or laser Other topical treatment specific to vitiligo Other immunosuppressant or immunomodulator
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 |
|---|---|---|
| tacrolimusAlso: Protopictacrolimus 0.1% ointment applied twice a day for the experimental group during 24 weeks placebo ointment applied twice a day for the control group during 24 weeks | Drug | Tacrolimus group |
| Placebo | Drug | Control group |
Primary outcome
Percentage of repigmented surface area of the target lesion ≥75%
Time frame: One year
To test the efficacy of a 24 weeks months Tacrolimus 0.1% ointment treatment vs placebo in an adult population with stable non-segmental vitiligo of the face. Therapeutic success is defined as the variation in percentage of repigmented surface area of the target lesion ≥75% at 24 weeks months.
10 secondary outcomes
Variation in percentage of repigmented surface area
Time frame: 24 weeks
Variation in percentage of repigmented surface area
Time frame: 48 weeks
Variation of patient's global satisfaction using Likert score
Time frame: 12 weeks
Variation of patient's global satisfaction using Likert score
Time frame: 24 weeks
Variation of patient's global satisfaction using Likert score
Time frame: 48 weeks
Variation of the physician global evaluation of treatment efficacy
Time frame: 12 weeks
Variation of the physician global evaluation of treatment efficacy
Time frame: 24 weeks
Variation of the physician global evaluation of treatment efficacy
Time frame: 48 weeks
Variation of the Dermatology Life Quality Index
Time frame: 24 weeks
Number of participants with Adverse events
Time frame: 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 19 Apr 2021.
- Derived from this study: PubMed 33549606Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taieb A, Ezzedine K. Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study. J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.
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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.
Khaled EZZEDINE principal investigator
University Hospital Bordeaux, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus in people with Vitiligo, run by University Hospital, Bordeaux at 4 sites 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 5 inclusion and 12 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 repigmented surface area of the target lesion ≥75% (time frame: One year). 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 NCT02466997, 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 19 Apr 2021.