A 251-patient, multicenter randomized controlled trial in adults with localized non-segmental vitiligo reported that combining a 308 nm excimer laser with an oral JAK inhibitor delivered a 14.2% higher repigmentation rate versus monotherapy, achieved a reported 100% “significant efficacy” rate at 52 weeks, and showed the highest pigmentation stability at one year (96.5%) with the lowest relapse rate (8.8%). No serious or persistent adverse events were observed over the study period.
The investigator-initiated study, published in the International Journal of Dermatology, evaluates a well-established device modality alongside systemic JAK inhibition and concludes the combination outperforms monotherapy and conventional care on speed, degree, and durability of repigmentation. STRATA Skin Sciences, which markets the XTRAC excimer platform, is positioning the data to support ongoing efforts to expand reimbursement across vitiligo, psoriasis, and other inflammatory dermatoses, leaning on a larger-than-usual sample size for a dermatology device trial.
Strategically, this is a defense-and-expand maneuver for an in-office light-based platform in an ecosystem tilting toward JAK-driven regimens. Anchoring excimer therapy within a combination framework aims to preserve procedure volume, differentiate the modality on durability, and recast an older technology as integral to modern immunomodulatory algorithms. The tension is obvious: oral JAK use in vitiligo is not uniformly labeled or reimbursed across markets, comes with class safety considerations, and could constrain uptake even if the device component is covered. The company’s focus on reimbursement—rather than new regulatory clearances—signals where the near-term hurdle lies: payer policy alignment more than technical validation.
For dermatology practices, the operational implications are tangible. Combination therapy extends treatment arcs across 52 weeks, requiring capacity planning for high-frequency light sessions, precise dosimetry, and tighter adherence management. Documentation burdens will rise as clinics align prior authorization narratives to combination protocols and track outcomes that matter to payers, including durability and relapse. Practices employing per-treatment partnership models will see clearer volume predictability if coverage expands, but will need to coordinate systemic prescribing, monitoring, and pharmacy logistics that many phototherapy workflows have historically avoided. For JAK manufacturers, the signal supports a device-drug pairing that could accelerate real-world utilization—if safety monitoring pathways and payer policies converge. CROs and sponsors looking at device-drug combinations in dermatology will note the feasibility of running adequately powered RCTs in this space, with endpoints that extend to one-year stability.
The payer and policy dimension is the swing factor. Insurers have been inconsistent on vitiligo phototherapy coverage, and systemic JAK reimbursement varies by indication and geography. A compelling combination effect invites reassessment, but real movement will depend on clarity around the specific JAK agent(s) used, dose, monitoring requirements, and comparative cost-effectiveness against topical ruxolitinib and narrowband UVB. Longer-term safety remains an open question; while the trial reports no serious adverse events, the class warnings associated with oral JAK inhibitors and theoretical concerns about combining immunomodulation with targeted UV exposure will push stakeholders to demand longer follow-up and registry data.
Watch for confirmatory trials specifying the JAK backbone and dosing, payer policy updates that explicitly address device-drug combinations in vitiligo, and guideline revisions that move excimer from an alternative to a co-standard in defined patient segments. If reimbursement broadens by 2026 as targeted, expect a near-term uptick in in-office procedure demand and a corresponding need for practices to scale phototherapy capacity, integrate safety monitoring for systemic agents, and formalize outcomes tracking to sustain coverage.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
