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

Nikolis, Andreas; Fauverghe, Stéphane; Scapagnini, Giovanni; Sotiriadis, Dimitrios; Kontochristopoulos, George; Petridis, Athanasios K.; Rigopoulos, Dimitrios; Dessinioti, Clio; Kalokasidis, Konstantinos; Antoniou, Christina

doi:10.1111/ijd.13349

Cited by 42 publications

(48 citation statements)

References 31 publications

(70 reference statements)

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“…Additionally, in the following two measurements, days 4 and 6, the mean wound sizes of the BL group still ranked as the smallest sizes (4 days: ~31%, P < 0.1 vs control; 6 days: ~19%, P < 0.1 vs control), which showed that the blue light phototherapy performed best in wound‐healing promotion. Indeed, there was not much doubt that blue light promoted wound healing, given the great role played in antibiosis and disinfection, which was also illustrated in previous studies .…”

Section: Resultssupporting

confidence: 55%

LED Phototherapy with Gelatin Sponge Promotes Wound Healing in Mice

Zhang

Liu

Yang

et al. 2017

Photochem & Photobiology

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Tiny but highly efficient, a light-emitting diode (LED) can power a therapy device, such as a phototherapy device, and, at the same time, decrease the device's size requirements. In this study, a LED phototherapy device was designed to investigate the possible impact on wound healing using a mouse model and a cell line exposed to red and blue light. To enhance wound phototherapy, a gelatin sponge was fabricated. Results showed that the red and blue lights promoted cell growth and wound healing, while the blue light with a gelatin sponge protected the wound from infection in the early stages of wound healing. The LED phototherapy device combined with the gelatin sponge, therefore, has potential significance in clinical application for wound healing.

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Section: Resultssupporting

confidence: 55%

LED Phototherapy with Gelatin Sponge Promotes Wound Healing in Mice

Zhang

Liu

Yang

et al. 2017

Photochem & Photobiology

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“…Compliance was excellent despite the young age of the patients and the long study period (at least 24 weeks considering the total duration of the Main and the Extension trials). Serious adverse events after treatment were not observed and as previously reported the BioPhotonic System was safe and well tolerated . One limitation of this trial might be that most the patients included were female (71%).…”

Section: Discussionmentioning

confidence: 77%

“…reported that blue light therapy at 414 nm significantly reduces inflammatory acne lesions by 50.02% at the 12‐week assessment. In our previous multicenter, randomized, split‐face study, we demonstrated that the use of chromophore‐assisted blue light phototherapy twice weekly for 6 weeks was efficacious, resulting in a reduction of at least 2 grades in the IGA scale in a statistically significant number of treated hemifaces of patients at 12 weeks (51.7% compared to 18.0% of the untreated hemifaces) . To build on these results, long‐term studies should also be carried out to demonstrate maintenance of efficacy and to assess safety parameters of blue light phototherapy in the treatment of acne.…”

Section: Discussionmentioning

confidence: 99%

“…Enrolled female subjects had a negative pregnancy test, and participants were willing to practice birth control during their participation into study. Patients meeting any of the exclusion criteria outlined in the first study protocol were excluded . There was an average of 39.3 days between the last visit of the first study and the screening visit of this extension study.…”

Section: Methodsmentioning

confidence: 99%

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An extension of a multicenter, randomized, split‐face clinical trial evaluating the efficacy and safety of chromophore gel‐assisted blue light phototherapy for the treatment of acne

et al. 2017

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A variety of laser/light-based devices have been reported to be effective for the treatment of acne, yet no long-term data on efficacy and safety have been published. A first 12-week clinical trial ("Main trial") recently demonstrated that the KLOX BioPhotonic System, an LED blue light device using photo-converter chromophores, can significantly improve moderate and severe facial acne vulgaris with an excellent safety profile. This Extension trial followed the Main trial, using the same BioPhotonic System, with the same dose and instructions for use, on patients having already completed treatment in the Main trial. Main objectives of this open-label long-term extension 12-week study were to evaluate the efficacy of the KLOX BioPhotonic System on the untreated hemiface during the Main trial, as well as the duration of response on the hemiface treated during the first 12-week Main trial. Despite their young age (mean age: 21.6 years) and their 12-week participation in the Main trial, 49 (54.4%) of the total number of patients who participated in the Main trial enrolled in this additional 12-week Extension trial. Baseline grading of acne was performed with the Investigator's Global Assessment (IGA) scale. For each patient, the hemiface randomly selected as a control during the Main trial received 6 weeks of treatment (twice weekly) and was then followed up for an additional 6 weeks. The first hemiface treated in the Main trial was consequently observed throughout the Extension trial, allowing for a further 12-week assessment of outcomes (total 24 weeks). In light of an additional 12 weeks of treatment on the contralateral face, the patient compliance rate was excellent, with 91.9% of the total number of patients receiving at least 80% of the treatments.Patients with a baseline IGA grade of 2 (mild) on the treated hemiface demonstrated a success rate of 58.3 and 66.7% at weeks 6 and 12, respectively. At these same time points, subjects with a baseline IGA grade of 3 (moderate) demonstrated a success rate of 81.8 and 90.0%. Patients with a baseline IGA grade of 4 (severe) demonstrated a success rate of 100% at both week 6 and week 12. When evaluating the originally treated hemifaces from the Main trial, the rate of return to baseline at 24 weeks was calculated to be 15.5%. This latter outcome confirmed the long duration of effect following treatment.The patient safety profile was also excellent, with very few related adverse events. The BioPhotonic System, which is comprised of LED blue light phototherapy and photoconverter chromophores, provides long-term efficacy and safety in the treatment of acne vulgaris, with a rate of compliance above what is generally observed in a young population of patients suffering from acne vulgaris, especially in light of sequential enrollment in a study treating one hemiface.

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“…With great interest we have read the article of Antoniou et al . regarding the efficacy of a new photoconverter gel‐assisted blue light therapy (PALT) for the treatment of acne.…”

mentioning

confidence: 99%