Health TrialsbyHealthPanel

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

ConditionNonSegmental Vitiligo
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorIncyte Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 6 to < 12 years at the time of signing the ICF.

Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI.

Total body vitiligo area does not exceed 10% BSA.

Pigmented hair within some of the areas of vitiligo on the face.

Disqualifiers

Diagnosis of other forms of vitiligo (eg, segmental).

Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).

Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.

Prior or current use of depigmentation treatments (eg, monobenzone).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ruxolitinib Cream

    Drug

    Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

  • Vehicle Cream

    Drug

    Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Treatment groups

250 Participants
are divided into 3 treatment groups
Group A: Ruxolitinib 0.75 % CreamExperimental treatment 1 intervention
Group B: Ruxolitinib 1.5 % CreamExperimental treatment 1 intervention
Group C: Vehicle CreamPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)

≥50% improvement in facial Vitiligo Area Scoring Index.

Time frame
Week 24
2

Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)

≥90% improvement in facial Vitiligo Area Scoring Index.

Time frame
Week 24
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Incyte Corporation

Lead sponsor

Source ClinicalTrials.gov
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