VitiligoPhase 3NCT02156427
Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism
A Phase 3 study testing VITICELL in people with Vitiligo and Piebaldism, run by Laboratoires Genévrier at 5 sites in 3 countries.
Trial summary
The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo. The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo, Piebaldism
- What is being tested?
- VITICELL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 29 Apr 2014to 10 Apr 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
- Men and women aged over 18 years old with a diagnosis of non-scaring leukoderma that has been stable over the last 2 years (non-segmental, segmental vitiligo and piebaldism)
- For non-segmental vitiligo: symmetrical vitiligo lesions, or parts of a lesion. A part of at least 1 cm2 (1 x 1 cm), but preferable 4 cm2 (2x2 cm) and preferably in the center of each lesions (left/right) should be treated.
- The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.
- For segmental vitiligo lesion and piebaldism: all lesions possible if two parts of at least 1 cm2 (1 x 1 cm), but preferably 4 cm2 (2 x 2 cm) in the lesion can be treated. The minimum distance between the 2 areas should be 2 cm and between test areas and to the normal pigmented skin preferably at least 0.5 cm.
- Medical treatments of vitiligo failed (in case of vitiligo: at least cream treatment for 6 months).
- Absence of infected lesion
- Negative serology (HIV-hepatitis B and C- Syphilis)
- Without treatment one month for cream and 3 months for phototherapy
Who cannot join
- Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
- Indication against biopsies
- Patient with a history of melanoma
- Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C-Syphilis)
- Positive pregnancy test
- History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b)
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- Infected lesion
- Test areas not on fingers and toes vitiligo areas in case of non-segmental vitiligo
- Test areas not on facial non segmental vitiligo
- Pregnant women, or lactating
- Age <18years
- Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
France3 sites
University Hospital Center of Bordeaux
Bordeaux
CHU Le Mans
Le Mans
Dr Michel PASCAL
Paris
About this study
Official title: A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)
The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo.
The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator.
- Conditions
- Vitiligo, Piebaldism
- Being tested
- VITICELL, PLACEBO
- Medical subject headings
- Vitiligo, Piebaldism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITICELLDevice
graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid
PLACEBODevice
hyaluronic acid alone
| Study group | Role | What they receive |
|---|---|---|
| VITICELL | Experimental | In this arm, lesions will be treated by autologous epidermal cells suspension (containing hyaluronic acid) obtained after VITICELL kit's use, a class III medical device. Receives: Device: VITICELL |
| PLACEBO | Placebo comparator | In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells. Receives: Device: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful repigmentation
succesful repigementation define as more than or equal to 50% repigmentation of the treated area
Measured: at month 6
Secondary outcomes (1)
Rate of successful repigmentation
succesful repigementation define as more than or equal to 50% repigmentation of the treated area
Measured: at month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study start29 Apr 2014
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, prospective, multicenter, randomised, controlled trial patient is his own control
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Genévrier
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nanja Van Geel, Pr, Principal investigator, Gent hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156427
- Sponsor's protocol ID
- 13INT/VIT01
- Status last verified
- Oct 2019
- First submitted
- 30 May 2014
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)
- ClinicalTrials.gov ID
- NCT02156427
- Acronym / sponsor ID
- 13INT/VIT01
- Conditions
- Vitiligo, Piebaldism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Laboratoires GenévrierIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2014 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 5 Jun 2014 (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.
The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo.
The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blind, prospective, multicenter, randomised, controlled trial patient is his own control
| Arm | Type | Receives |
|---|---|---|
| VITICELL | Experimental | Device: VITICELLIn this arm, lesions will be treated by autologous epidermal cells suspension (containing hyaluronic acid) obtained after VITICELL kit's use, a class III medical device. |
| PLACEBO | Placebo comparator | Device: PLACEBOIn this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged over 18 years old with a diagnosis of non-scaring leukoderma that has been stable over the last 2 years (non-segmental, segmental vitiligo and piebaldism)
- For non-segmental vitiligo: symmetrical vitiligo lesions, or parts of a lesion. A part of at least 1 cm2 (1 x 1 cm), but preferable 4 cm2 (2x2 cm) and preferably in the center of each lesions (left/right) should be treated.
- The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.
- For segmental vitiligo lesion and piebaldism: all lesions possible if two parts of at least 1 cm2 (1 x 1 cm), but preferably 4 cm2 (2 x 2 cm) in the lesion can be treated. The minimum distance between the 2 areas should be 2 cm and between test areas and to the normal pigmented skin preferably at least 0.5 cm.
- Medical treatments of vitiligo failed (in case of vitiligo: at least cream treatment for 6 months).
Key exclusion criteria (12 listed)
- Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
- Indication against biopsies
- Patient with a history of melanoma
- Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C-Syphilis)
- Positive pregnancy test
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 |
|---|---|---|
| VITICELLgraft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid | Device | VITICELL |
| PLACEBOhyaluronic acid alone | Device | PLACEBO |
Primary outcome
Rate of successful repigmentation
Time frame: at month 6
succesful repigementation define as more than or equal to 50% repigmentation of the treated area
1 secondary outcome
Rate of successful repigmentation
Time frame: at month 12
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 14 Oct 2019.
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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.
Nanja Van Geel, Pr principal investigator
Gent hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VITICELL in people with Vitiligo and Piebaldism, run by Laboratoires Genévrier at 5 sites in 3 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 8 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Belgium, Italy. 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?
Rate of successful repigmentation (time frame: at month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2019.