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

Rhea-AI Summary

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.

Positive

• 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

Negative

• None.

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:

1. 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.
2. Superior Efficacy – showing a 14.20% higher repigmentation, indicating synergistic effects.
3. Unprecedented Response Rates – following 52 weeks of treatment had a 100% significant efficacy rate.
4. 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.
5. 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

What were the key findings of STRATA Skin Sciences' (SSKN) Excimer laser and JAK inhibitor combination study?

The study showed 14.20% higher repigmentation, 100% efficacy rate after 52 weeks, 96.5% pigmentation stability, and 8.8% relapse rate at one-year follow-up, with excellent safety profile.

How many patients participated in STRATA Skin Sciences' vitiligo treatment study?

The study included 251 patients, making it larger than typical contemporary dermatology studies.

When will STRATA Skin Sciences (SSKN) implement expanded reimbursement for their treatment?

STRATA is targeting to implement expanded reimbursement for their treatment modality by the beginning of 2026.

What was the safety profile of STRATA's combination therapy for vitiligo?

The combination therapy demonstrated an excellent safety profile with no serious or persistent adverse events reported during the study.

How long has STRATA's Excimer laser technology been in use?

The Excimer laser technology has been in use for approximately 20 years, with over 400 studies and peer-reviewed papers supporting its efficacy.