Phase
Condition
Vitiligo
Treatment
Ruxolitinib Topical
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thanone 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 fromscreening through the final safety follow-up visit.
Exclusion
Exclusion Criteria:
Pregnant or breast-feeding women. Or women who plan to get pregnant during the studyduration.
Segmental or mixed vitiligo
Vitiligo lesions located only on face, feet, or fingers. (dorsum of the handaccepted).
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 ortrypsin)
Active infection
Patients with thromboembolic risk
Any dermatosis located on the treated site that could interfere with the evaluationof the treatment
Vulnerable people: pregnant or breast-feeding women, minors, adult underguardianship or deprived of freedom
Participants in other clinical therapeutic studies involving a drug that couldinterfere with the present evaluation
Participants with active acute bacterial, fungal, or viral skin infection within 1week before baseline;
Participants with concurrent malignant disease or a history of that in the 5 yearspreceding the baseline visit except for adequately treated non metastaticmalignancies;
Participants with current and/or history of liver disease, including known hepatitisB 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 vitiligoor other pigmented areas.
Patient under guardianship or curatorship
Study Design
Connect with a study center
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-maritimes 06200
FranceSite Not Available

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