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
RECRUITINGHospital Italiano de Buenos Aires
Buenos Aires, Argentina
RECRUITINGInstituto de Neumonologia Y Dermatologia
Buenos Aires, Argentina
RECRUITINGConsultorios Medicos Dr. Doreski
Buenos Aires, Argentina
RECRUITINGDerma Internacional S.A.
Buenos Aires, Argentina
RECRUITINGHospital Universitario Austral
Derqui-pilar, Argentina
RECRUITINGCentro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Argentina
RECRUITINGHospital Del Nino Jesus
San Miguel de Tucumán, Argentina
RECRUITINGUniversitaetsklinikum Graz
Graz, Austria
RECRUITINGMedical University Innsbruck
Innsbruck, Austria
RECRUITING...and 69 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