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

Last updated: January 17, 2025
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Completed

Phase

2

Condition

Vitiligo

Treatment

Ruxolitinib Topical

Placebo

Clinical Study ID

NCT05872477
22-PP-16
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women with non-segmental vitiligo.

  2. ≥ 18 and <80 years.

  3. At least one pair bilateral of stable vitiligo lesions with a surface >2cm² and < 20cm², located outside the face unresponsive to medical treatment

  4. For women of child-bearing age, an effective contraception (estroprogestative pill,contraceptive implant, IUD, condoms or tubal ligation) should be used for more thanone month before the inclusion in the study. A urine pregnancy test (βHCG in urines)will be performed.

  5. Affiliation to a social security system

  6. Signed informed consent

  7. Participants who agree to discontinue all agents used to treat vitiligo fromscreening through the final safety follow-up visit.

Exclusion

Exclusion Criteria:

  1. Pregnant or breast-feeding women. Or women who plan to get pregnant during the studyduration.

  2. Segmental or mixed vitiligo

  3. Vitiligo lesions located only on face, feet, or fingers. (dorsum of the handaccepted).

  4. Concomitant use of topical or systemic immunosuppressive medication or steroids

  5. Previous treatment with topical ruxolitinib cream or any systemic JAK inhibitor

  6. Areas that have already received surgical grafting

  7. Patients suffering from photodermatosis or taking photosensitive drugs

  8. Medical history of hypertrophic scars or keloids

  9. Medical history of skin cancer on the site to be treated

  10. Allergy to ruxolitinib cream, xylocaine or hyaluronic acid or trypsin (Viticell®must not be utilised with patients who are hypersensitive to hyaluronic acid ortrypsin)

  11. Active infection

  12. Patients with thromboembolic risk

  13. Any dermatosis located on the treated site that could interfere with the evaluationof the treatment

  14. Vulnerable people: pregnant or breast-feeding women, minors, adult underguardianship or deprived of freedom

  15. Participants in other clinical therapeutic studies involving a drug that couldinterfere with the present evaluation

  16. Participants with active acute bacterial, fungal, or viral skin infection within 1week before baseline;

  17. Participants with concurrent malignant disease or a history of that in the 5 yearspreceding the baseline visit except for adequately treated non metastaticmalignancies;

  18. Participants with current and/or history of liver disease, including known hepatitisB or C, with hepatic or biliary abnormalities;

  19. Participants with current and/or history of tuberculosis;

  20. Participants who have used depigmentation treatments for past treatment of vitiligoor other pigmented areas.

  21. Patient under guardianship or curatorship

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Ruxolitinib Topical
Phase: 2
Study Start date:
September 05, 2023
Estimated Completion Date:
January 10, 2025

Connect with a study center

  • CHU de Nice - Hôpital de l'Archet

    Nice, Alpes-maritimes 06200
    France

    Site Not Available

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