STRATA Skin Sciences Announces First Patients Treated in TheraClear®X Clinical Study for Acne
Study evaluating efficacy and safety of TheraClearX on mitigating mild to moderate acne in healthy teenagers and young adults
HORSHAM, Pa., May 30, 2023 (GLOBE NEWSWIRE) — STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced that the first six patients have been treated in the TheraClear®X open label, single-arm, clinical research study led by Glynis Ablon, MD, FAAD.
The purpose of the study titled, “A 7-Week, Open Label, Study Evaluating the Efficacy and Safety of TheraClearX on Mitigating Mild to Moderate Acne in Healthy Teenagers and Young Adults,” is to further substantiate the efficacy and safety of TheraClearX as a stand-alone treatment in the mitigation of mild to moderate acne in 30 healthy male and female subjects, 12-40 years of age and older over the course of 7 weeks. The study is being conducted at the Ablon Skin Institute and Research Center in Manhattan Beach, California.
“Dr. Ablon’s clinical study will help further validate the efficacy and safety of TheraClearX as a stand-alone acne treatment therapy,” stated Bob Moccia, Chief Executive Officer of STRATA Skin Sciences. “TheraClearX has the potential to make a meaningful impact on those who suffer from mild to moderate acne through our vacuum technology and intense broadband light that targets the sebaceous glands. We expect patients that have been seen in the clinic to experience visible reductions in acne lesions.”
“We are excited to have treated the first six patients in our TheraClearX clinical study,” stated Dr. Glynis Ablon, MD, FAAD. “TheraClearX offers patients a non-pharmaceutical option to help treat patients with mild to moderate acne with no numbing cream necessary, and no pain. We look forward to reporting our findings to the scientific community at the conclusion of the study.”
Acne is the most common skin disease in the United States affecting up to 50 million Americans annually.1 Research shows that 20-25% of all visits to dermatologists are for acne, and the majority of the cases are for those who suffer from a mild to moderate version.2 Acne is also prevalent in adolescents with 85% experiencing some degree from the ages of 12 to 24 years.3 TheraClearX’s FDA-cleared technology addresses the estimated $5.5 billion acne treatment market with a non-pharmaceutical, in-office procedure.
About TheraClear®X
TheraClearX is engineered and indicated specifically for the treatment of acne. By combining vacuum technology and intense broadband light (500nm-1200nm), TheraClearX shows significant promise in the fight against acne. For best results, it is recommended patients complete 4-6 treatment sessions (scheduled 1-2 weeks apart), dependent on acne severity. Treatments can be completed in 15-20 minutes and are pain-free.
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 an acne treatment device and to integrate that device into its product offerings, the Company’s ability to develop, 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 dermatologist 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 the coronavirus, fiscal, and political factors, 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:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
sskn@cg.capital
References
1Bickers DR et al.J AmAcad Dermatol. 2006;55:490-500
2Tan JKL, Bhate K. Br J Dermatol. 2015;172 (Suppl 10:3-12.
3White GM. J AmAcad Dermatol. 1998;39:S34-S37.
