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

NCT05872477 | Completed Phase 2

• 1 other identifier: 22-PP-16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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.

  At three months and visit inclusion.

Study Arms (2)

Group treatment

EXPERIMENTAL

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.

Drug: Ruxolitinib Topical

group placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Ruxolitinib Topical DRUG

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.

Group treatment

Placebo DRUG

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.

group placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, 06200, France

Location

MeSH Terms

Conditions

Vitiligo

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Passeron Thierry, PhD

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 24, 2023
• Study Start: September 5, 2023
• Primary Completion: February 8, 2024
• Study Completion: January 10, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

FR (1)