An announcement was made by Accure Acne, Inc., a company known for its acne treatment solutions, that they received Clearance K242035 from the US Food and Drug Administration (FDA) for the long-term treatment of patients with mild to severe inflammatory acne vulgaris.1
Acne, one of the most common inflammatory skin conditions, can be effectively treated in almost all people with the condition. The severity of the condition as well as the morphology of the disease and the characteristics of the patient such as skin color, age, psychological burden and motivation to treat the disease are essential elements before choosing the treatment.2
The company’s ‘Accure Laser System’ is a treatment that implements the unique 1726 nm laser wavelength. It features proprietary technology designed to precisely control the depth of the thermal gradient for the purpose of targeting the sebaceous gland.
“This achievement is a testament to the relentless pursuit of this goal by Accure, Quanta System and the team of clinicians and researchers who have spent many years together to bring the Accure Laser to the world,” Emil Tanghetti, MD, founder of The Dermatology and Laser Surgery Center and Accure Laser first investigator, said in a statement. “Our journey in understanding the unique nature of this wavelength and the clinical requirements needed to achieve meaningful clinical results has certainly been challenging.”1
Tanghetti noted that using temperature as an endpoint is a technical innovation that, combined with forced air cooling and real-time monitoring algorithms, provided a new option that stands out from more traditional energy-based methods.
During multiple clinical trials in the U.S. approved by their Institutional Review Boards (IRBs), the laser’s “treatment-to-temperature” approach was fully validated. The studies showed an average 70% reduction in the number of inflammatory lesions in users 6 months after 4 treatments each spaced out by a month. The results were also noted to be consistent across many different skin types and severity levels.
In early 2024, there was a limited commercial launch in the US completed by Accure Acne for a laser system. They demonstrated strong clinical outcomes as well as high levels of satisfaction among providers and patients. Specifically, satisfaction scores averaged over 4.4 out of 5.
After this period, the company expanded the availability of the Accure Laser System to regions such as Europe, the Caribbean, the Middle East and Asia Pacific. In their announcement, Accure noted that patients regardless of skin type or acne severity level can now benefit from the effective, safe and long-lasting results of their laser system.
“This achievement cannot be overstated,” Christopher Carlton, Accure Acne co-founder, chairman and CEO, said in a statement. “After many years of rigorous technical, scientific and clinical development, The Accure Laser has achieved yet another milestone achievement – the ability to provide an important, lasting and durable drug-free alternative for acne patients and their providers.”
References
- Accure Acne Announces New FDA Clearance for Long-Term Acne Treatment. Accure Acne, Inc. 15 October 2024. Date accessed: 15 October 2024.
- Eichenfield DZ, Sprague J, Eichenfield LF. Management of Acne Vulgaris: A Review. GLASS. 2021;326(20):2055–2067. doi:10.1001/jama.2021.17633.
