Ruxolitinib 1.5% Cream in Nonsegmental Vitiligo: TRuE-V2 Phase 3 Results

Key Takeaways

TRuE-V2 confirmed facial repigmentation superiority of ruxolitinib 1.5% cream versus vehicle at ~24 weeks, mirroring TRuE-V1.
Continued treatment produced progressive gains beyond the vehicle-controlled period; non-facial improvement lagged facial endpoints.
Safety remained favorable with mainly mild local reactions; systemic exposure was low for a topical agent.
Data support maintenance strategies and combination with light therapy for refractory sites (e.g., acral).

Abstract

TRuE-V2, a sister phase 3 to TRuE-V1, evaluated ruxolitinib 1.5% cream for nonsegmental vitiligo using facial (F-VASI) and total-body (T-VASI) endpoints. This article summarizes design, dosing, principal efficacy findings, safety, and implications for maintenance and integration with phototherapy.

Trial Design

Table 1. TRuE-V2 design overview.

Element	Details
Type	Phase 3, randomized, double-blind, vehicle-controlled
Duration	~24 weeks vehicle-controlled + open-label extension
Masking	Participants, investigators, assessors blinded during core period
Assessments	Standardized photography; centralized/assessor-blinded reads where applicable

Participants

Table 2. Eligibility and baseline notes.

Category	Criteria/Notes
Inclusion	Age ≥12; nonsegmental vitiligo with facial involvement sufficient for F-VASI
Exclusion	Recent systemic immunosuppressants; photosensitivity; uncontrolled dermatoses
Baseline	Mixed phototypes; facial & non-facial lesions; acral involvement in subset

Interventions & Dosing

Table 3. Dosing schema.

Arm	Regimen	Notes
Ruxolitinib 1.5% cream	Thin layer to lesions, typically BID	Apply after emollient if irritation; avoid occlusion
Vehicle	Matched schedule	Eligible for switch to active in extension

Endpoints

Primary: Facial repigmentation threshold by F-VASI at ~24 weeks.
Secondary: T-VASI change; patient/physician global assessment; time to perifollicular islands; durability on extension.
Exploratory: QoL (DLQI/VitiQoL); hair follicle–associated repigmentation patterns.

Efficacy Results

Ruxolitinib cream outperformed vehicle for facial endpoints during the vehicle-controlled period and continued to improve with ongoing therapy. Non-facial responses were slower; acral sites were least responsive.

Table 4. Representative outcomes (framework for data entry).

Outcome	Ruxolitinib cream	Vehicle	Interpretation
F-VASI responders (week ~24)	Higher proportion	Lower proportion	Primary endpoint met
T-VASI % change	Greater reduction	Smaller reduction	Consistent secondary benefit
Time to visible islands	Earlier	Later	Predictive of endpoint
Durability (extension)	Maintained/improved	—	Supports continued use

Safety

Table 5. Common adverse events.

Event	Ruxolitinib cream	Vehicle	Notes
Application-site acne	More frequent	Less frequent	Usually mild; spacing/cleansers help
Erythema/pruritus	Occasional	Occasional	Typically transient
Headache/URTI	Similar to vehicle	Similar	Non-differentiating

Low systemic exposure observed with topical dosing; class warnings for JAK inhibitors remain part of labeling considerations.

Maintenance & Combination Use

Consider maintenance application to preserve gains after plateau.
For acral or slow-responding sites, add NB-UVB or excimer 308 nm.
Standardize photo tracking and F-VASI/T-VASI to guide taper decisions.

Limitations

Facial endpoints may overrepresent total-body benefit; access/cost factors and real-world adherence influence outcomes; limited data on long-term off-drug durability.

References

TRuE-V2 phase 3 publication reporting F-VASI/T-VASI outcomes with ruxolitinib 1.5% cream versus vehicle.
Extension/pooled analyses of TRuE-V1/V2 describing durability and safety with continued therapy.
Methodology resources on VASI scoring and blinded photographic assessment.