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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

NCT05872477 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-20

No results posted yet for this 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.

Conditions

  • Vitiligo

Interventions

DRUG

Ruxolitinib Topical

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Passeron Thierry, PhD · CHU de Nice, Service de Dermatologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2024-02-08
Completion
2025-01-10

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872477 on ClinicalTrials.gov