New Peer Reviewed Publication of Combination Therapy in Vitiligo with STRATA Skin Sciences’ Excimer Laser and JAK Inhibitors Demonstrated Superior Safety and Unprecedented Response Rates, Providing Continued Validation of Personalized Medicine Approach
STRATA Skin Sciences (NASDAQ: SSKN) has announced significant findings from a 251-patient randomized controlled study combining their 308nm Excimer laser with JAK inhibitors for vitiligo treatment. The study, published in the International Journal of Dermatology, demonstrated superior efficacy with 14.20% higher repigmentation compared to monotherapy.
Key results include 100% significant efficacy rate after 52 weeks of treatment, 96.5% pigmentation stability, and a low 8.8% relapse rate at one-year follow-up. The combination therapy showed excellent safety with no serious adverse events. This research supports STRATA's pursuit of expanded reimbursement for various indications, with the company targeting implementation by early 2026.
STRATA Skin Sciences (NASDAQ: SSKN) ha annunciato risultati significativi da uno studio controllato randomizzato su 251 pazienti che combina il laser Excimer 308 nm con inibitori JAK per il trattamento della vitiligine. Lo studio, pubblicato sull'International Journal of Dermatology, ha dimostrato una superiorità dell'efficacia con una repigmentazione del 14,20% rispetto alla monoterapia.
Risultati chiave: 100% di efficacia significativa dopo 52 settimane di trattamento, 96,5% di stabilità della pigmentazione e un tasso di ricaduta dell'8,8% al follow-up di un anno. La terapia combinata ha mostrato un'ottima sicurezza senza eventi avversi gravi. Queste ricerche sostengono l'obiettivo di STRATA di ampliare i rimborsi per diverse indicazioni, con l'azienda che punta all'implementazione entro l'inizio del 2026.
STRATA Skin Sciences (NASDAQ: SSKN) anunció hallazgos significativos de un ensayo aleatorizado de 251 pacientes que combina su láser Excimer de 308 nm con inhibidores de JAK para el tratamiento de la vitiligo. El estudio, publicado en el International Journal of Dermatology, demostró una eficacia superior con una repigmentación un 14,20% mayor que la monoterapia.
Resultados clave: tasa de eficacia significativa del 100% tras 52 semanas de tratamiento, 96,5% de estabilidad de la pigmentación y un 8,8% de recaída en el seguimiento de un año. La terapia de combinación mostró una excelente seguridad sin eventos adversos graves. Esta investigación respalda la búsqueda de STRATA de ampliar la cobertura/reembolso para diversas indicaciones, con la empresa apuntando a su implementación para principios de 2026.
STRATA Skin Sciences (NASDAQ: SSKN)은 251명의 환자를 대상으로 한 무작위 대조 연구에서 308nm 엑시머 레이저와 JAK 억제제를 결합한 백반증 치료의 중요한 발견을 발표했습니다. 국제 피부과학 저널에 게재된 이 연구는 단일 요법에 비해 재색화가 14.20% 더 우수한 효능을 보였습니다.
주요 결과로는 52주 치료 후 효능 유의성 100%, 피부 색소 유지율 96.5%, 1년 추적에서 재발률 8.8%이 보고되었습니다. 결합 요법은 심각한 이상반응 없이 우수한 안전성을 보였습니다. 이 연구는 다양한 적응증에 대한 보험 보장 확대를 지지하며, 회사는 2026년 초까지 구현을 목표로 하고 있습니다.
STRATA Skin Sciences (NASDAQ: SSKN) a annoncé des résultats significatifs d'une étude contrôlée randomisée portant sur 251 patients, associant son laser Excimer 308 nm à des inhibiteurs de JAK pour le traitement de la vitiligo. L'étude, publiée dans l'International Journal of Dermatology, a démontré une efficacité supérieure avec une repigmentation de 14,20% par rapport à la monothérapie.
Résultats clés : taux d'efficacité significative de 100% après 52 semaines de traitement, 96,5% de stabilité de la pigmentation et 8,8% de taux de rechute lors du suivi d'un an. La thérapie combinée a démontré une excellente sécurité sans événements indésirables graves. Cette recherche soutient les efforts de STRATA pour élargir le remboursement pour diverses indications, l'entreprise visant une mise en œuvre début 2026.
STRATA Skin Sciences (NASDAQ: SSKN) hat signifikante Ergebnisse einer randomisierten Studie mit 251 Patienten bekannt gegeben, die ihren 308-nm-Excimer-Laser mit JAK-Hemmern zur Vitiligo-Behandlung kombiniert. Die in der International Journal of Dermatology veröffentlichte Studie zeigte eine überlegene Wirksamkeit mit 14,20% höherer Repigmentierung im Vergleich zur Monotherapie.
Wesentliche Ergebnisse: 100% signifikante Wirksamkeit nach 52 Wochen Behandlung, 96,5% Pigmentationsstabilität und eine Recidivrate von 8,8% nach einem Jahr Follow-up. Die Kombinationstherapie zeigte eine hervorragende Sicherheit ohne schwere unerwünschte Ereignisse. Diese Forschung unterstützt Stratas Bestrebungen, die Erstattung für verschiedene Indikationen auszuweiten, mit dem Ziel der Umsetzung bis Anfang 2026.
STRATA Skin Sciences (ناسداك: SSKN) أعلنت عن نتائج مهمة من دراسة عشوائية محكومة شملت 251 مريضاً، تجمع بين ليزر Excimer 308nm ومثبطات JAK لعلاج البهاق (فينتيليغو). الدراسة، المنشورة في International Journal of Dermatology، أظهرت فعالية متفوقة مع زيادة في إعادة التصبغ بنسبة 14,20% مقارنة بالعلاج الأحادي.
النتائج الرئيسية تشمل معدل فعالية ذي دلالة 100% بعد 52 أسبوعاً من العلاج، استقرار التصبغ بنسبة 96,5%، ومعدل انتكاس منخفض 8,8% عند المتابعة لمدة عام. أظهرت هذه المعالجة المدمجة أماناً ممتازاً بدون أحداث جانبية خطيرة. تدعم هذه الدراسة سعي STRATA لتوسيع التغطية/التعويض لمؤشرات متعددة، مع استهداف الشركة للتنفيذ بحلول أوائل 2026.
STRATA Skin Sciences（纳斯达克股票代码：SSKN）宣布了一项包含251名参与者的随机对照研究的重大发现，该研究将其308nm准分子激光与JAK抑制剂用于白斑病治疗。该研究发表在《International Journal of Dermatology》上，显示相对于单药治疗，联合治疗在色素再沉着方面提高了14.20%。
关键结果包括治疗52周后达到100%的显著疗效、色素稳定性为96.5%，以及一年随访时的8.8%复发率。联合治疗显示出良好的安全性，未出现严重不良事件。这项研究支持STRATA扩大对多种适应症的报销范围，公司目标在2026年初实现实施。
- Achieved 100% significant efficacy rate in combination therapy after 52 weeks
- Demonstrated 14.20% higher repigmentation compared to monotherapy
- Achieved 96.5% pigmentation stability with only 8.8% relapse rate
- Study validates expanded reimbursement application for multiple indications
- Large-scale study with 251 patients provides robust evidence base
- None.
Insights
STRATA's Excimer laser shows exceptional results when combined with JAK inhibitors for vitiligo treatment, potentially expanding market opportunities.
The newly published study represents a significant advancement in vitiligo treatment, demonstrating STRATA's Excimer laser technology achieves superior results when combined with JAK inhibitors. The 251-patient randomized controlled trial provides robust evidence with five remarkable findings: mechanistic synergy between the treatments, 14.20% higher repigmentation rates, a 100% significant efficacy rate after 52 weeks, impressive durability with 96.5% pigmentation stability at one-year follow-up, and an excellent safety profile with no serious adverse events.
This publication strengthens STRATA's position in three critical ways. First, it validates the continued relevance of their 20-year-old Excimer technology in the modern treatment landscape. Second, it supports their application for expanded reimbursement coverage across multiple dermatological conditions including vitiligo, psoriasis, and others. Third, it positions their treatment approach as personalized medicine – a significant competitive advantage in today's healthcare market.
What's particularly notable is the durability of results, with only an 8.8% relapse rate in the combination therapy group – substantially outperforming monotherapy approaches. The study adds to an extensive body of over 400 existing studies supporting the technology, strengthening the company's case for expanded insurance coverage potentially by early 2026. This could substantially increase STRATA's addressable market across multiple inflammatory and autoimmune skin conditions, including atopic dermatitis, alopecia areata, and lichen planus.
Investigator-initiated randomized controlled combination trial published in the International Journal of Dermatology confirms its superiority to monotherapy, fueling continued market growth and expanding indications
HORSHAM, Pa., Sept. 22, 2025 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, highlights a recent peer reviewed and randomized controlled study of its 308nm Excimer laser in combination with an oral Janus kinase (JAK) inhibitor that demonstrated superior efficacy, unprecedented response rates, and excellent safety profile relative to monotherapy or conventional treatment. The 251-patient study, published in the International Journal of Dermatology, titled “308nm Excimer Laser Combined with JAK Inhibitors for Adult Localized Non-Segmental Vitiligo: A Multicenter Randomized Controlled Trial,” illustrates the continued interest in the Company’s well-established technology, in addition to showing more rapid, better results and durable repigmentation in combination vitiligo therapy relative to monotherapy. The study is also supportive of the Company’s current pursuit of expanded reimbursement for a variety of indications, including vitiligo, psoriasis, and others.
The study counts five key findings relating to the combination of Excimer Laser and JAK inhibitor:
- Mechanistic Synergy – pointing out that the synergy likely arises as JAK inhibitors suppress IFN-γ–driven CD8+ T-cell cytotoxicity, whereas excimer laser promotes melanocyte migration through UV-induced paracrine signals like α-MSH and endothelin-1.
- Superior Efficacy – showing a
14.20% higher repigmentation, indicating synergistic effects. - Unprecedented Response Rates – following 52 weeks of treatment had a
100% significant efficacy rate. - Durable Stability - At 1-year follow-up, the combination group demonstrated the highest pigmentation stability (
96.5% ) and lowest relapse rate (8.8% ), outperforming the monotherapy and control groups. - Excellent Safety Profile - No serious or persistent adverse events occurred.
Strata CEO Dr. Dolev Rafaeli commented, “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. It is even more encouraging in light of the fact that our technology has been in use for around 20 years. Dermatologists continue to rely on the superior performance of our Excimer technology for durable repigmentation in these difficult to manage immunomodulated skin conditions. The addition of JAK inhibiting treatments has enhanced the efficacy of the therapy without compromising safety, and repigmentation has shown high stability with very little relapse.
“These results were published in the last month, adding to a wealth of over 400 studies and/or peer-reviewed papers that exists in the literature today, which we believe to be a strong validation of our recent application for expanded reimbursement. Care providers continue to rely on the value of our approach, which in combination therapy with JAK inhibitors and other therapies, can be considered personalized medicine given the duration of the laser exposure and dosage of the corresponding treatment. We continue to work with regulators to provide expanded access to our treatment modality by the beginning of 2026,” concluded Dr. Rafaeli.
This pivotal trial adds to the substantial body of clinical evidence confirming the 308 nm excimer laser as a cornerstone therapy for inflammatory and autoimmune skin diseases, including vitiligo, psoriasis, atopic dermatitis, alopecia areata, and lichen planus. With 251 patients enrolled, this study provides a robust evidence base, offering sufficient power to support the reliability and generalizability of its findings. With over two decades of published data, excimer laser therapy is uniquely positioned as a proven, targeted, and safe treatment option across a broad range of dermatologic conditions.
Excimer laser continues to play a pivotal role alongside emerging systemic treatments, ensuring patients have access to therapies that are not only innovative, but also clinically validated, targeted, and safe.
About STRATA Skin Sciences, Inc.
STRATA Skin Sciences is a medical technology company dedicated to developing, commercializing, and marketing innovative products for the in-office treatment of various dermatologic conditions, such as psoriasis, vitiligo, and acne. Its products include the XTRAC® excimer laser, VTRAC® lamp systems, and the TheraClear®X Acne Therapy System.
STRATA is proud to offer these exciting technologies in the U.S. through its unique Partnership Program. STRATA’s popular partnership approach includes a fee per treatment cost structure versus an equipment purchase, installation and use of the device, on-site training for practice personnel, service and maintenance of the equipment, dedicated account and customer service associates, and co-op advertising support to help raise awareness and promote the program within the practice.
Safe Harbor
This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to launch and sell products recently acquired or to be developed in the future, the Company’s ability to develop social media marketing campaigns, direct to consumer marketing campaigns, and the Company’s ability to build a leading franchise in dermatology and aesthetics, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions labor supply shortages, or supply chain interruptions resulting from fiscal, political factors, tariffs, international conflicts, responses, or conditions affecting the Company, the medical device industry and our customers and patients in general, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances occurring after the date of this press release. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.
Investor Contact:
CORE IR
516-222-2560
IR@strataskin.com
FAQ
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