The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in children (6 to \< 12 years old) with nonsegmental vitiligo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
250
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
≥75% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
≥50% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
≥90% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 24
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
≥50% improvement in total body Vitiligo Area Scoring Index.
Time frame: Week 24
Percentage change from baseline in F-BSA
Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Time frame: Week 24
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to Week 52 and 30 days
Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable)
The VNS is a patient-reported measure of vitiligo treatment success that has a 5-point scale.
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Psoriahue
Buenos Aires, Argentina
NOT_YET_RECRUITINGHospital Italiano de Buenos Aires
Buenos Aires, Argentina
NOT_YET_RECRUITINGInstituto de Neumonologia Y Dermatologia
Buenos Aires, Argentina
NOT_YET_RECRUITINGConsultorios Medicos Dr. Doreski
Buenos Aires, Argentina
NOT_YET_RECRUITINGDerma Internacional S.A.
Buenos Aires, Argentina
NOT_YET_RECRUITINGCentro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Argentina
NOT_YET_RECRUITINGHospital Universitario Austral
Pilar, Argentina
NOT_YET_RECRUITINGHospital Del Nino Jesus
San Miguel de Tucumán, Argentina
NOT_YET_RECRUITINGUniversitaetsklinikum Graz
Graz, Austria
RECRUITINGMedical University Innsbruck
Innsbruck, Austria
NOT_YET_RECRUITING...and 76 more locations
Time frame: Week 24 and Week 52
Proportion of participants in each category for the color-matching question
The color-matching question is a patient-reported measure of vitiligo treatment success that has a 5-point scale.
Time frame: Week 24 and Week 52
Proportion of participants who report facial assessment of Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of very much improved or much improved
The F-PaGIC-V is an assessment of improvement by the participant that has a 7-point scale.
Time frame: Week 24 and Week 52
Proportion of participants who report total body assessment of Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of very much improved or much improved
The T-PaGIC-V is an assessment of improvement by the participant that has a 7-point scale.
Time frame: Week 24 and Week 52
Change from baseline in Psychosocial Impact Questionnaire for Pediatric Patients Who Have Nonsegmental Vitiligo (VIT-PIQ)
The VIT-PIQ is a 17-item questionnaire to assess Quality of Life (QOL) of children with vitiligo.
Time frame: Week 24 and Week 52
Change from baseline in Children's Dermatology Life Quality Index (CDLQI)
The CDLQI is the youth/children's version of the Dermatology Life Quality Index.
Time frame: Week 24 and Week 52
Change from baseline in Patient Global Impression of Bother - Vitiligo (PGIB-V)
The PGIB-V is a single question with an 11-point scale ("not at all" to "a whole lot") to assess the participant's level of bother because of their vitiligo.
Time frame: Week 24 and Week 52
Mean satisfaction score
The treatment satisfaction tool is a fit-for-purpose questionnaire to assess treatment satisfaction in children with nonsegmental vitiligo.
Time frame: Week 24 and Week 52
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Time frame: Weeks 6, 24, 30 and 52