KLOX Technologies has received CE mark approval in Europe for its topical photo-converter gel for the treatment of acne vulgaris. The gel is part of the company’s LumiCleanse System, a non-invasive acne vulgaris treatment that combines LED light and a topical photo-converter gel. According to a company press release, the non-abrasive and non-thermal treatment protocol—including skin preparation—can be performed in 15 minutes. Patients undergo treatment twice a week for six weeks. The system was approved for the treatment of all severities of acne vulgaris in Canada in September of this year.
The approval of the medical device application was based on a European registration trial that demonstrated effectiveness in moderate to severe acne vulgaris patients. The study showed that the treatment was clinically and statistically significant on the primary (p < 0.0001) and all of the secondary endpoints, with an extremely favorable safety profile.
"We are pleased to reach another significant milestone in our regulatory and commercial roadmap and in our efforts to expand the reach of KLOX's innovative treatment in the $3 billion global acne market,” said Lise Hebert, president and CEO of KLOX. “Europe represents a significant pool of potential patients with unmet needs when it comes to the effective treatment of mild to severe acne.”