A groundbreaking multicenter randomized controlled trial involving 251 patients has demonstrated that combining STRATA Skin Sciences' 308nm excimer laser with oral Janus kinase (JAK) inhibitors achieves unprecedented efficacy in treating vitiligo, with a 100% significant response rate after 52 weeks of treatment.
The study, published in the International Journal of Dermatology and titled "308nm Excimer Laser Combined with JAK Inhibitors for Adult Localized Non-Segmental Vitiligo: A Multicenter Randomized Controlled Trial," represents one of the largest patient populations in contemporary dermatology studies and provides robust evidence for combination therapy approaches.
Superior Efficacy and Response Rates
The combination therapy demonstrated 14.20% higher repigmentation compared to monotherapy approaches, indicating clear synergistic effects between the two treatment modalities. Following 52 weeks of treatment, the combination group achieved an unprecedented 100% significant efficacy rate, substantially outperforming both monotherapy and control groups.
At one-year follow-up, the combination therapy group maintained the highest pigmentation stability at 96.5% with the lowest relapse rate of 8.8%, significantly outperforming monotherapy and control groups. These results suggest that the combination approach not only provides superior initial response but also delivers more durable therapeutic outcomes.
Mechanistic Synergy and Safety Profile
The study identified clear mechanistic synergy between the two treatment approaches. According to the research, JAK inhibitors suppress IFN-γ–driven CD8+ T-cell cytotoxicity, while excimer laser promotes melanocyte migration through UV-induced paracrine signals including α-MSH and endothelin-1. This complementary mechanism of action explains the enhanced therapeutic response observed in the combination group.
Importantly, the combination therapy demonstrated an excellent safety profile with no serious or persistent adverse events occurring throughout the 52-week treatment period. This safety data is particularly significant given the concerns often associated with systemic immunomodulatory treatments.
Clinical and Commercial Implications
Dr. Dolev Rafaeli, CEO of STRATA Skin Sciences, emphasized the significance of these findings: "This investigator-initiated study, which features a much larger patient population than normally seen in contemporary dermatology studies, highlights the continued interest in our Excimer laser technology, and the promise of combination therapy."
The results add to over 400 studies and peer-reviewed papers supporting excimer laser technology, with Dr. Rafaeli noting that "dermatologists continue to rely on the superior performance of our Excimer technology for durable repigmentation in these difficult to manage immunomodulated skin conditions."
Intellectual Property and Market Position
STRATA holds exclusive patents for combination therapies using excimer laser with JAK inhibitors, systemic drugs, and biologic treatments. These patents protect the combined use of excimer laser therapy with systemic pharmacologic agents for treating inflammatory and autoimmune skin diseases including psoriasis, atopic dermatitis, leukoderma, alopecia areata, and vitiligo.
The 308nm excimer laser technology allows for precise, high-dose, localized UVB exposure, delivering therapeutic light energy to affected skin areas while sparing healthy tissue. The patents strategically address limitations of monotherapy by combining phototherapy with systemic treatments to deliver synergistic therapeutic effects, including enhanced treatment response, prolonged remission, potential dosage reduction for systemic drugs, and improved safety through limited UV exposure to affected areas only.
Regulatory and Reimbursement Developments
The American Medical Association's CPT Editorial Panel has approved updates to codes 96920–96922, expanding reimbursement eligibility for XTRAC Excimer Laser treatments to include all inflammatory and autoimmune skin conditions effective January 1, 2027. STRATA is pursuing temporary CMS codes to make these expanded indications reimbursable as early as the 2026 rule cycle, which could effectively triple the addressable patient population while improving treatment economics for providers and the company.
Dr. Rafaeli concluded: "We continue to work with regulators to provide expanded access to our treatment modality by the beginning of 2026." The combination of strong clinical evidence, intellectual property protection, and expanded reimbursement coverage positions STRATA's excimer laser technology as a cornerstone therapy for multiple dermatologic conditions.
