EU approves LumiCleanse gel (KLOX Tech) for Acne

KLOX Technologies has received CE mark approval in Europe for the topical photo-converter gel component in its LumiCleanse system, a Class IIa Medical Device for the treatment of Acne vulgaris, including all severities. The LumiCleanse System is comprised of a multi-LED light, which activates the topical photo-converter gel applied on the affected area.

Approval is based on a study in which the system demonstrated effectiveness in moderate to severe Acne vulgaris patients and was clinically and statistically significant on the primary and all of the secondary endpoints, with a favourable safety profile. The three month extension study demonstrated a similar effectiveness and safety profile. The persistence of effect was maintained in 92% of the cohort who had met the primary efficacy endpoint in the registration trial, thus demonstrating a persistence of effect of at least 6 months.