A multicenter, randomized, split-face clinical trial evaluating the efficacy and safety of chromophore gel-assisted blue light phototherapy for the treatment of acne.

Abstract

Although a variety of laser/light-based devices have been reported to be effective for the treatment of acne, long-term data on efficacy and safety in the management of moderate and severe inflammatory acne is lacking. The objective of this 12-week clinical trial was to evaluate the efficacy and safety of the KLOX BioPhotonic System, a LED blue light device using specific photo-converter chromophores, in the treatment of moderate to severe acne vulgaris. One patient hemiface was randomly selected to receive 6 weeks of treatment (twice weekly) with the LED light and the photo-converter chromophores whereas the contralateral hemiface was not treated with the BioPhotonic System. All patients were provided with a skin cleanser and a non-comedogenic cream with ultraviolet protection to be used on the entire face during the treatment period. Following completion of the 6-week treatment period, the patient was followed for an additional 6 weeks. Efficacy was assessed through changes in acne severity using the Investigator's Global Assessment (IGA) scale and inflammatory acne lesion counts, both evaluated against baseline at weeks 6 and 12. Safety was assessed through physical exam, vital signs, laboratory evaluations, and physician and patient reporting of adverse events. A reduction of at least two grades in IGA scale severity was demonstrated in 51.7% of patients at week 12. Furthermore, at week 12, subjects with a baseline IGA grade of 3 (moderate) demonstrated a success rate (2 or greater grade drop) of 45.3% whereas patients with a baseline IGA grade of 4 (severe) demonstrated a success rate of 61.1%. Acne inflammatory lesion counts confirmed these results, with a reduction of at least 40% of lesions in 81.6% of treated hemifaces after 12 weeks. Treatment was considered as safe and well tolerated, with no serious adverse event and no patient discontinuation from the study from any adverse event. Patients' quality of life was also improved with a decrease of pain linked to acne after the 6-week treatment period. The BioPhotonic System comprised of LED blue-light phototherapy and photo-converter chromophores was found to be efficacious and safe, with a sustained clinical response at 12 weeks for the management of moderate to severe facial inflammatory acne.