Sebacia, Inc., a company dedicated to delivering breakthrough treatments to advance dermatology, has announced new research showing that selective targeting of sebaceous glands using the Sebacia Treatment, which could be a new effective in-office procedure for acne, one of the most common dermatological diseases. Sebacia Treatment is an investigational device that uses proprietarily designed gold microparticles in combination with an approved dermatology hair removal laser to target sebaceous glands responsible for acne.
The results were published in the Journal of Investigative Dermatology, which is part of the Nature Publishing Group and is considered the number one journal of dermatology research.
"Dermatology hair removal lasers have a large installed base and are routinely and safely used to reduce unwanted hair, and we believe with Sebacia's gold microparticles they can also provide sustained relief from acne," said Anthony Lando, Sebacia's CEO. "These clinical studies show that the Sebacia Treatment delivers a robust and significant reduction in the appearance and occurrence of inflammatory acne lesions."
Unlike other acne prescriptions that require daily use of lotions or pills, the Sebacia Treatment is intended to reduce acne with a few, simple treatments performed at a dermatologist's office. In two randomized and controlled clinical studies, Sebacia Treatment provided clinically and statistically significant improvement of inflammatory acne compared to sham treatment. After three treatments with the Sebacia System given one to two weeks apart, results were seen as early as four weeks post-treatment.
"We expect to complete enrollment in our U.S. pivotal clinical trial in the next few months and begin our application to the FDA to register the Sebacia Treatment as an approved device to treat moderate to severe acne," said Mr. Lando. "If approved, the Sebacia Treatment would be the first topical in combination with a laser used by a dermatologist in-office that is intended to provide long-term relief from acne."
Additional histology studies revealed that the Sebacia Treatment preferentially targeted the sebaceous follicles and glands. Redness and swelling after the procedure were mild and transient. Looking a month later, it was observed that no gold microparticles were retained in the skin.
One of the researchers from the study and specialist in dermatology, Dr. Witold Owczarek, said, "Sebacia treatment provided a significant and sustained reduction in acne for the patients in our clinical study. As a simple, two-step, in-office treatment, the Sebacia Treatment could provide an essential alternative to the daily use of topical and systemic drugs."
About Sebacia Microparticles
Made of gold and silica, Sebacia microparticles are specially designed to be activated by the light from commonly used hair removal lasers and are placed in a suspension designed to penetrate the sebaceous follicles. When exposed to a laser pulse, they create a focused photothermal effect in the sebaceous gland and follicle to reduce the activity level of the gland and the inflammatory lesions that cause acne.