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Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas (PREVENT)

Primary Purpose

Vitiligo

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ruxolitinib Topical
Placebo
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women with non-segmental vitiligo. ≥ 18 and <80 years. At least one pair bilateral of stable vitiligo lesions with a surface >2cm² and < 20cm², located outside the face unresponsive to medical treatment For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed. Affiliation to a social security system Signed informed consent Participants who agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Exclusion Criteria: Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration. Segmental or mixed vitiligo Vitiligo lesions located only on face, feet, or fingers. (dorsum of the hand accepted). Concomitant use of topical or systemic immunosuppressive medication or steroids Previous treatment with topical ruxolitinib cream or any systemic JAK inhibitor Areas that have already received surgical grafting Patients suffering from photodermatosis or taking photosensitive drugs Medical history of hypertrophic scars or keloids Medical history of skin cancer on the site to be treated Allergy to ruxolitinib cream, xylocaine or hyaluronic acid or trypsin (Viticell® must not be utilised with patients who are hypersensitive to hyaluronic acid or trypsin) Active infection Patients with thromboembolic risk Any dermatosis located on the treated site that could interfere with the evaluation of the treatment Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or deprived of freedom Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation Participants with active acute bacterial, fungal, or viral skin infection within 1 week before baseline; Participants with concurrent malignant disease or a history of that in the 5 years preceding the baseline visit except for adequately treated non metastatic malignancies; Participants with current and/or history of liver disease, including known hepatitis B or C, with hepatic or biliary abnormalities; Participants with current and/or history of tuberculosis; Participants who have used depigmentation treatments for past treatment of vitiligo or other pigmented areas. Patient under guardianship or curatorship

Sites / Locations

  • CHU de Nice - Hôpital de l'ArchetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group treatment

group placebo

Arm Description

There will be 2 arms with intra individual comparison. After 7 days the dressing will be removed. Each grafted side of the body will be randomly assigned to receive twice daily application of topical 1.5% ruxolitinib cream After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.

Each grafted side of the body will be randomly assigned to receive twice daily application of placebo cream (Group B). After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.

Outcomes

Primary Outcome Measures

Repigmentation of the target area
The primary objective will be assessed using the depigmentation of the target lesion. A drawing of the target lesions will be done at V1 (week 0), V5 (week 12) and V6 (wk24). Repigmentation of the target area will be calculated using Image J software in order to have an objective measurement of the response. We will define success as a repigmentation ≥50%, repigmentation being define as the difference of depigmentation between M3 and M0.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2023
Last Updated
October 12, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05872477
Brief Title
Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas
Acronym
PREVENT
Official Title
Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas. Prospective Monocentric Interventional Study With Blinded Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
August 5, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Medical approaches remain the gold standard treatment for non-segmental forms of vitiligo. Topical ruxolitinib cream has demonstrated its efficacy and good tolerance for treating vitiligo. While about 30% of patients will achieve at least 90% of repigmentation on the face after 1 year of treatment, some locations on the body, such as hands, feet, bony prominences remain highly challenging, and most patients won't get satisfactory repigmentation on those areas despite months of application of topical treatments, even when combined with UV. The poor rate of repigmentation in these locations are probably explained by the difficulty to stimulate the differentiation and proliferation of melanocytes stem cells in those areas. To study the efficacy at 3 months of epidermal cell suspension grafting followed by twice daily applications topical 1.5% ruxolitinib cream compared to epidermal cell suspension grafting followed by placebo in vitiligo resistant areas.There will be 2 arms with intra individual comparison. Both groups will receive epidermal cell suspension (provided by Cutiss®). After 7 days the dressing will be removed. Each grafted side of the body will be randomly assigned to receive twice daily application of topical 1.5% ruxolitinib cream (Group A) or twice daily application of placebo cream (Group B). After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.There will be 8 visits in total during the 7 months duration for each subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
There will be 2 arms with intra individual comparison. Each grafted side of the body will be randomly assigned to receive twice daily application of topical 1.5% ruxolitinib cream (Group A) or twice daily application of placebo cream (Group B). After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group treatment
Arm Type
Experimental
Arm Description
There will be 2 arms with intra individual comparison. After 7 days the dressing will be removed. Each grafted side of the body will be randomly assigned to receive twice daily application of topical 1.5% ruxolitinib cream After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.
Arm Title
group placebo
Arm Type
Placebo Comparator
Arm Description
Each grafted side of the body will be randomly assigned to receive twice daily application of placebo cream (Group B). After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib Topical
Intervention Description
There will be 2 arms with intra individual comparison. Both groups will receive epidermal cell suspension (provided by Cutiss®). After 7 days the dressing will be removed. Each grafted side of the body will be randomly assigned to receive twice daily application of topical 1.5% ruxolitinib cream (Group A) or twice daily application of placebo cream (Group B). After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
There will be 2 arms with intra individual comparison. Both groups will receive epidermal cell suspension (provided by Cutiss®). After 7 days the dressing will be removed. Each grafted side of the body will be randomly assigned to receive twice daily application of topical 1.5% ruxolitinib cream (Group A) or twice daily application of placebo cream (Group B). After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.
Primary Outcome Measure Information:
Title
Repigmentation of the target area
Description
The primary objective will be assessed using the depigmentation of the target lesion. A drawing of the target lesions will be done at V1 (week 0), V5 (week 12) and V6 (wk24). Repigmentation of the target area will be calculated using Image J software in order to have an objective measurement of the response. We will define success as a repigmentation ≥50%, repigmentation being define as the difference of depigmentation between M3 and M0.
Time Frame
At three months and visit inclusion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women with non-segmental vitiligo. ≥ 18 and <80 years. At least one pair bilateral of stable vitiligo lesions with a surface >2cm² and < 20cm², located outside the face unresponsive to medical treatment For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed. Affiliation to a social security system Signed informed consent Participants who agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Exclusion Criteria: Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration. Segmental or mixed vitiligo Vitiligo lesions located only on face, feet, or fingers. (dorsum of the hand accepted). Concomitant use of topical or systemic immunosuppressive medication or steroids Previous treatment with topical ruxolitinib cream or any systemic JAK inhibitor Areas that have already received surgical grafting Patients suffering from photodermatosis or taking photosensitive drugs Medical history of hypertrophic scars or keloids Medical history of skin cancer on the site to be treated Allergy to ruxolitinib cream, xylocaine or hyaluronic acid or trypsin (Viticell® must not be utilised with patients who are hypersensitive to hyaluronic acid or trypsin) Active infection Patients with thromboembolic risk Any dermatosis located on the treated site that could interfere with the evaluation of the treatment Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or deprived of freedom Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation Participants with active acute bacterial, fungal, or viral skin infection within 1 week before baseline; Participants with concurrent malignant disease or a history of that in the 5 years preceding the baseline visit except for adequately treated non metastatic malignancies; Participants with current and/or history of liver disease, including known hepatitis B or C, with hepatic or biliary abnormalities; Participants with current and/or history of tuberculosis; Participants who have used depigmentation treatments for past treatment of vitiligo or other pigmented areas. Patient under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Passeron Thierry, PhD
Phone
+33492036488
Email
passeron.t@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle Pradelli
Phone
+33492036488
Email
pradelli.e@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, PhD
Organizational Affiliation
CHU de Nice, Service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Hôpital de l'Archet
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PASSERON thierry, PhD
Phone
+33492036488
Email
passeron.t@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Pradelli emmanuelle
Phone
+33492036488
Email
pradelli.e@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas

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