The Canadian based company's ‘LumiCleanse’ treatment, comprised of a multi-LED light, activates a topical photo-converter gel applied on the affected area to treat acne vulgaris.
According to Klox representatives, acne vulgaris accounts for over 30% of dermatology visits and over 40% of those suffering from this disease are looking for treatments with a better safety and efficacy profile than what is currently available.
"We are pleased to reach another significant milestone in our regulatory and commercial roadmap and in our efforts to expand the reach of this treatment. Europe represents a significant pool of potential patients with unmet needs when it comes to the effective treatment of mild to severe acne," says CEO Dr. Lise Hébert.
New type of treatment...
The skin disease affects over 150 million people worldwide, and can have drastic physical, social and psychological effects on those who suffer from it, particularly in moderate to severe cases.
Reps say that many of the current topical, oral and light-based treatments on the market are characterized by inconsistent efficacy/persistence, systemic treatment schedules, problems with patient tolerability and in most cases, side-effects.
Thus, in this instance the company set about developing a treatment that targets the underlying problems that lead to disease as well as stimulating collagen in traumatized skin.
"LumiCleanse is designed to promote healing in both the epidermis and deeper in the dermis in a non-invasive manner. Completed within a 15-minute treatment cycle including preparation, the treatment requires applications twice a week for a six-week period," Hébert explains.
Trial before approval
The clinical evidence for the device application was based on a European registration trial conducted in Europe.
In the study, Klox reps say the system demonstrated effectiveness in moderate to severe acne vulgaris patients and was clinically and statistically significant on the primary (p < 0.0001) and all of the secondary endpoints, with an extremely favourable safety profile.
The three month extension study is said to have 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."