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

Background: 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. Methods: 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. Results: 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. Conclusions: 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. © 2016 The Authors. The International Society of Dermatology published by John Wiley & Sons Ltd on behalf of International Society of Dermatology

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

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. © 2017 The Authors

Assessing physicians' preferences on skin cancer treatment in Europe

BACKGROUND: A wide variety of both surgical and nonsurgical therapies is currently available for patients with skin cancer. OBJECTIVES: This part of the EPIDERM (European Prevention Initiative for Dermatological Malignancies) project is aimed at the evaluation of the treatment preferences for skin cancer in eight countries of the European Union. METHODS: A multicentre hospital-based case-control study was carried out at dermatology departments in Finland, Germany, Greece, Italy, Malta, Poland, Scotland and Spain. Patients with skin cancer (basal cell carcinoma, actinic keratosis, squamous cell carcinoma, cutaneous malignant melanoma and Bowen disease) were consecutively enrolled between July 2008 and July 2010. Information on the study variables (sex, age, country, tumour type, anatomical location and treatment) was obtained from questionnaires designed by the EPIDERM project. RESULTS: In total, 1708 patients with skin cancer were included. Surgery was the first treatment option in 76\ub75% of the patients (P = 0\ub7001). Actinic keratosis was the only tumour type in which nonsurgical treatment was more frequent than surgery (91\ub74%). Tumours on the head were less likely to be surgically excised than those at other locations (odds ratio 0\ub725, P = 0\ub7001). Simple excision or curettage was the most common surgical procedure (65\ub74%), followed by graft and flaps (22\ub74%). Cryotherapy was the most common nonsurgical option (52\ub74%), followed by imiquimod (18\ub70%), photodynamic therapy (PDT; 12\ub70%), 5-fluorouracil (5-FU; 5\ub77%), and diclofenac with hyaluronic acid (4\ub70%). CONCLUSIONS: Surgery remains the first-choice treatment of skin cancer. Regarding nonsurgical treatments, the conservative treatments available (imiquimod, 5-FU, PDT and diclofenac gel) have not yet exceeded the use of ablative options such as cryotherapy despite their accepted benefit of treating field cancerization

The patient journey: a report of skin cancer care across Europe

BACKGROUND: There are poorly documented variations in the journey a skin cancer patient will follow from diagnosis to treatment in the European Union. OBJECTIVES: To investigate the possible difficulties or obstacles that a person with a skin malignancy in the European Union may have to overcome in order to receive adequate medical screening and care for his/her condition. In addition, we wished to explore differences in European health systems, which may lead to health inequalities and health inequities within Europe. METHODS: Ten European countries took part in this investigation (in alphabetical order): Finland, Germany, Greece, Italy, Malta, Poland, Romania, Spain, the Netherlands and the U.K. The individual participants undertook local and national enquiries within their own country and completed a questionnaire. RESULTS: This exercise has identified important differences in the management of a skin cancer patient, reflecting major disparities in health care between European countries. CONCLUSIONS: Further investigation of health disparities and efforts to address health inequalities should lead to improvements in European health care quality and reduction in morbidity from skin cancer

Skin cancer risk in outdoor workers: A European multicenter case-control study

Background Exposure to ultraviolet radiation (UVR) is the most important external risk factor for skin cancer. Outdoor workers, who are exposed to high ambient UVR levels are at increased risk. Objective To compare outdoor with indoor workers in terms of: (i) skin cancer risk factors, and (ii) risk of developing skin cancer. Methods Using descriptive methods and a large multicenter European case-control study, we compared risk factor patterns between outdoor (N = 1416) and indoor workers (N = 1863). Risk of developing basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma and actinic keratosis (AK) were analysed by type of work using multivariate logistic regression models, for three categories of work: indoor; farming/construction; other outdoor work. Results Although skin phototype was equally distributed by type of work, significantly less outdoor than indoor workers used sunscreen in their own country (44.3% vs. 60.2%), but had more outdoor hobbies (66.2% vs. 58.2%). Outdoor workers had lower educational levels, and felt less confident in understanding medical information and filling medical forms (all P < 0.001). Outdoor workers had more signs of photodamage (78.1% vs. 65.5%) and among the skin cancer patients, 37.7% of outdoor workers vs. 28.6% of indoor workers had ≥2 skin cancers diagnosed during their lifetime. Multivariate logistic regression models showed significantly increased risk of outdoor vs. indoor work for AK (ORother outdoor = 1.55, ORfarming/construction = 2.58), SCC (ORother outdoor = 1.32, ORfarming/construction = 2.77) and BCC (ORother outdoor = 1.53, ORfarming/construction = 1.83). No significant associations were found for melanoma. The risk of all types of skin cancer and AK was significantly increased for workers with ≥5 years of outdoor work. Conclusions Outdoor workers had more risk behaviour with similar constitutional skin cancer risk factors: more UV exposure (both occupational and leisure) and less sunscreen use and lower health literacy. This results in higher exposure, more photodamage and an increased risk of developing AK, BCC and SCC.SCOPUS: ar.jFLWINinfo:eu-repo/semantics/publishe