Attitudes and behaviors regarding sun exposure in Japan compared to Europe and North America.

The objective of our study was to assess the attitudes and behaviors in Japan regarding sun exposure and compare them to those in Europe and North America. The study population was a representative sample of individuals aged >18 years from Ipsos panels in Japan (N = 1000), North America (N = 1000), and Europe (N = 6000) using the quota method. Questionnaires covered habits, practices, and perceptions regarding sun exposure. Results revealed that the majority of people (80.1%) believed that the sun gives them energy, and 61.1% considered that being tanned made them look healthier. However, there was a significant difference between men and women regarding the appeal of tanned skin, with 54.95% of men versus 34.67% (p < 0.001) of women seeing a tan as an aesthetic asset. People aged <40 years were less likely to find a tan attractive (30.3%) compared to those aged ≥40 years (48.9%) (p < 0.001). Of those questioned, 45.70% of used sunscreen with a much higher use among women (70.10%) than men (18.74%) (p < 0.001). Almost 54% of people said they stayed in the shade to protect themselves from the sun with this behavior being more prevalent among women (67.05%) and fair-skinned individuals (56.13%). Fear of the risks of sun exposure was more common among women, with 84.8% fearing premature skin aging, compared to 71.8% of men (p < 0.001). In Japan, 44.30% of those questioned said tanned skin was attractive (p < 0.001); for Europeans and North Americans the proportions were 81.1% and 77.6%, respectively. Only a quarter (25.80%) thought it essential to return from vacation with a tan. On the other hand, Europeans showed a strong recognition of the energy the sun brings (83.18%), and widely believed that tanned skin is attractive (82.32%) and healthy (73.15%). In North America, attitudes were similar to those in Europe regarding the attractiveness of tanned skin (77.65%) and the importance of returning tanned from vacation (48.15%). Compared to Europeans and North Americans, the Japanese seemed to be more cautious about sun-induced hazards and considered lighter skin to be more attractive.

Impact of daily use of emollient 'plus' on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study.

BACKGROUND: Emollients are the baseline treatment for mild or moderate atopic dermatitis (AD) to improve the epidermal barrier and provide anti-irritant and anti-pruritic effects. Emollient 'plus' can influence the skin microbiome of atopic eczema patients. OBJECTIVES: To evaluate the benefits of using Emollient 'plus' to reduce corticosteroid consumption. METHODS: In an open, single-centre, randomized, controlled study, patients with mild to moderate AD (Severity scoring of AD [SCORAD] score 20-30) were randomized 1:1 to apply the Emollient 'plus' twice daily for 28 days or to continue with their usual classical emollient (Control group). In addition, each patient received topical corticosteroids to use when necessary and according to the dermatologist's prescription. Assessments included SCORAD, PO-SCORAD, local SCORAD, quality of life questionnaires, and tolerability. RESULTS: A total of 119 patients were included in the PP population with a mean age of 26.50 ± 17.5 years old (min-max 3-71 years). Between baseline and day 28, the mean amount of corticosteroid used was lower for the Emollient 'plus' versus Control group (6.03 vs. 9.16 g; p = 0.041) and corticosteroid was applied on fewer days (37.5% vs. 46.9% of days; p = 0.0256) with fewer applications per day (0.55 vs. 0.71 applications per day; p = 0.0203). Similar improvements were observed in both groups for SCORAD, PO-SCORAD, local SCORAD, skin sensation score, AD burden scale, patient benefit index >1, as well as subject and investigator efficacy and tolerability questionnaire assessments. CONCLUSIONS: Between baseline and day 28, there was significant corticosteroid-sparing in the Emollient 'plus' group compared to the Control group in quantity, number of applications per day and number of days of use, whilst efficacy was maintained with no significant differences between the two groups for all clinical evaluations, as well as for tolerability.

Skin, hair and beyond: the impact of menopause.

The skin is an endocrine organ and a major target of hormones such as estrogens, androgens and cortisol. Besides vasomotor symptoms (VMS), skin and hair symptoms often receive less attention than other menopausal symptoms despite having a significant negative effect on quality of life. Skin and mucosal menopausal symptoms include dryness and pruritus, thinning and atrophy, wrinkles and sagging, poor wound healing and reduced vascularity, whereas skin premalignant and malignant lesions and skin aging signs are almost exclusively caused by environmental factors, especially solar radiation. Hair menopausal symptoms include reduced hair growth and density on the scalp (diffuse effluvium due to follicular rarefication and/or androgenetic alopecia of female pattern), altered hair quality and structure, and increased unwanted hair growth on facial areas. Hormone replacement therapy (HRT) is not indicated for skin and hair symptoms alone due to the risk-benefit balance, but wider potential benefits of HRT (beyond estrogen's effect on VMS, bone, breast, heart and blood vessels) to include skin, hair and mucosal benefits should be discussed with women so that they will be able to make the best possible informed decisions on how to prevent or manage their menopausal symptoms.

Artificial Intelligence analysis of over half a million European and Chinese women reveals striking differences in the facial skin ageing process.

BACKGROUND: Artificial Intelligence (A.I) and deep learning-based algorithms are increasingly being used in dermatology following the emergence of powerful smartphones with high-resolution cameras. OBJECTIVES: To use an A.I-based algorithm, validated by dermatologists, to compare the evolution of the skin ageing process among Chinese and European women. METHODS: Selfie images were taken by 465 587 European and 79 016 Chinese women ranging from 18 to 85 and 18 to 69 years old, respectively, without facial skin diseases and who had access to a smartphone with a high-resolution camera (≥4 Megapixels). The selfies were analysed by facial skin diagnostic using a smartphone application to grade the severity of 9 facial signs (including wrinkles, sagging, vascular, pigmentation signs, pores). RESULTS: Wrinkles/texture, ptosis and sagging increased linearly with age in European women compared to lower scores and more gradual increase in the younger age-classes in Chinese women. In Chinese women, pigmentation signs increased regularly between 18 and 40 years, plateaued between 40 and 60 years, then increased in the over 60s compared to lower scores and a slower more regular increase with age in European women. Vascularization signs increased steadily with age in European women compared to no significant change in Chinese women. CONCLUSIONS: Marked differences were observed in the skin ageing process between European and Chinese populations, both in the prevalence of each facial ageing sign and their kinetics. Automatic grading performed on selfies and analysed by A.I is a fast and confidential method for quantifying signs of facial ageing and identifying the main issues for each population and age-class, which is of practical interest, as it will allow the development of tailored prevention and therapeutic measures.

Vichy volcanic mineralizing water has unique properties to strengthen the skin barrier and skin defenses against exposome aggressions.

Exposome aggressions are known to weaken certain skin functions, such as skin barrier and skin defense functions. Vichy volcanic mineralizing water (VVMW) percolates through volcanic and magmatic rocks in the Auvergne region in France to create a pure, highly mineralized water containing 15 minerals for a total mineral concentration of 5.2 g/L. Here, we provide an overview of the main results of in vitro and ex vivo studies (keratinocyte cultures, 3D reconstructed skin model, skin explants) and clinical studies to evaluate the effect of VVMW on key skin functions to help elucidate how it counteracts exposome aggressions on the skin. Properties to strengthen the skin barrier: VVMW stimulated the synthesis of tight junction proteins and keratinocyte differentiation markers in vitro. In clinical studies, VVMW accelerated cell turnover and improved skin hydration. Properties to strengthen skin antioxidant defense: VVMW stimulated the expression of antioxidant defense markers and had a higher stimulatory effect than a competitor thermal water on the expression of superoxide dismutase, catalase, and glutathione peroxidase in keratinocytes in vitro. In vivo, VVMW restored endogenous catalase activity after exposure to UVA radiation. Anti-inflammatory action: VVMW reduced substance P-induced inflammation ex vivo and lactic acid-induced stinging in vivo. Topical application of VVMW in subjects with sensitive skin showed soothing and decongestant effects by reducing skin dryness and erythema. After sodium lauryl sulfate -induced skin barrier disruption, recovery from redness and erythema was faster following application of VVMW compared to a competitor water or untreated skin. These studies illustrate that VVMW has unique properties to repair and regenerate the skin barrier, as well as to strengthen antioxidant and immune defenses, which help protect the skin against exposome aggressions.

A dermocosmetic formulation containing Vichy volcanic mineralizing water, Vitreoscilla filiformis extract, niacinamide, hyaluronic acid, and vitamin E regenerates and repairs acutely stressed skin.

The exposome has an impact on skin from life-long exposure. Acute short-term exposure to exposome stressors can also alter skin functions such as skin physical barrier and immune defenses, leading to skin dryness, sensitivity, flares of inflammatory skin conditions, or viral reactivations. Probiotics are defined as live microorganisms, which, when administered in adequate amounts, confer a health benefit on the host. An extract produced by lysing Vitreoscilla filiformis (VfeV) cultured in Vichy volcanic mineralizing water (VVMW) has properties of probiotic fractions. In this review, we present in vivo and ex vivo studies with a dermocosmetic formulation containing 80% VVMW, 5% VfeV, 4% niacinamide (vitamin B3), 0.4% hyaluronic acid, and 0.2% vitamin E (M89PF) to evaluate the clinical efficacy in preventing and repairing stressed skin. Skin barrier benefits of M89PF were shown in studies after the skin was exposed to sudden thermal changes, after skin irritation by tape stripping, and in sleep-deprived women. M89PF significantly accelerated skin renewal compared to untreated skin. Skin antioxidant defense activity of M89PF was shown after exposure to stress from UVA plus cigarette smoke aggression. Skin microbiome recovery after acute stress from a harsh cleanser was significantly better in M89PF-treated skin compared to bare skin. Clinical benefits of M89PF on correcting clinical signs of stressed skin were shown in both Caucasian and Asian women exposed to a stressful lifestyle and various external (pollution, tobacco smoking, solar radiation) and internal (poor sleep, stressful work, unbalanced diet, and alcohol consumption) exposome factors. M89PF also showed depigmenting properties on dark spots in Asian women. Further clinical studies are now warranted to evaluate the efficacy of M89PF as adjuvant care to prevent and repair skin barrier disruption and reinforce skin defenses in skin exposed to acute stresses.

A combination of Vitreoscilla filiformis extract and Vichy volcanic mineralizing water strengthens the skin defenses and skin barrier.

Probiotics are live microorganisms, which, when administered in adequate amounts, confer a health benefit on the host. Semiactive, non-replicating bacteria or extracts used in dermocosmetics have interesting properties for skin quality. Vitreoscilla filiformis is cultured by a fermentation process to obtain an extract. It is considered as a probiotic fraction and topical application of this extract has shown activity to strengthen the skin physical barrier function and maintain good homeostasis of skin defenses. Vichy volcanic mineralizing water (VVMW) is a pure, highly mineralized water that has been shown to strengthen the skin against exposome aggressions. This manuscript reviews properties of probiotic fractions used in skin care, especially studies on an extract of V. filiformis grown in a medium containing VVMW (VfeV) and evaluated in combination with VVMW. Skin barrier function: In normal human epidermal keratinocyte cultures, the combination of 10% VVMW and 0.002% VfeV significantly increased transglutaminase, filaggrin, involucrin, claudin-1, and zonula occludens-1 in comparison with the controls. Antimicrobial peptide defenses: The combination of 16.7% VVMW and 0.1% VfeV increased the expression of ß-defensin-4A and S100A7. Skin immune defense functions: In lipopolysaccharide-stimulated peripheral blood mononuclear cells, the combination of 16.7% VVMW and 0.1% VfeV down-regulated IL-8, TNF-α, IL-12/IL-23p40, and increased IL10 and IL-10/IL-12 ratio compared to the control. Additionally, the combination of 79% VVMW plus 5% VfeV protected Langerhans cells in skin explants exposed to ultraviolet radiation. In conclusion, the combination of VfeV plus VVMW has properties to strengthen the skin barrier by stimulating skin differentiation and tight junctions, biochemical defenses by stimulating antimicrobial peptides, and cellular immune defenses by increasing the IL-10/IL-12 ratio and by protecting Langerhans cells challenged by ultraviolet radiation.

Adult skin acute stress responses to short-term environmental and internal aggression from exposome factors.

Exposome factors that lead to stressed skin can be defined as any disturbance to homeostasis from environmental (meteorological factors, solar radiation, pollution or tobacco smoke) and/or internal exposure (unhealthy diet, hormonal variations, lack of sleep, psychosocial stress). The clinical and biological impact of chronic exposome effects on skin functions has been extensively reviewed, whereas there is a paucity of information on the impact of short-term acute exposure. Acute stress, which would typically last minutes to hours (and generally no more than a week), provokes a transient but robust neuroendocrine-immune and tissue remodelling response in the skin and can alter the skin barrier. Firstly, we provide an overview of the biological effects of various acute stressors on six key skin functions, namely the skin physical barrier, pigmentation, defences (antioxidant, immune cell-mediated, microbial and microbiome maintenance), structure (extracellular matrix and appendages), neuroendocrine and thermoregulation functions. Secondly, we describe the biological and clinical effects on adult skin from individual exposome factors that elicit an acute stress response and their consequences in skin health maintenance. Clinical manifestations of acutely stressed skin may include dry skin that might accentuate fine lines, oily skin, sensitive skin, pruritus, erythema, pale skin, sweating, oedema and flares of inflammatory skin conditions such as acne, rosacea, atopic dermatitis, pigmentation disorders and skin superinfection such as viral reactivation. Acute stresses can also induce scalp sensitivity, telogen effluvium and worsen alopecia.

Effectiveness of a formulation containing peptides and vitamin C in treating signs of facial ageing: three clinical studies.

OBJECTIVE: Vitamin C and peptides are widely used in cosmetic products but there is a paucity of clinical studies showing that the formulations are effective in treating signs of facial ageing. These 3 clinical studies evaluated the effectiveness of an anti-ageing formula containing natural vitamin C (10%), biopeptides (rice and lupin), hyaluronic acid, and Vichy volcanic mineralising water, in amber glass ampoules with no preservatives (Peptide-C ampoules). METHODS: Dansyl chloride fluorescence labelling compared cell turnover for Peptide-C ampoules vs untreated skin in 32 female subjects. Study 2, an open clinical study, evaluated the efficacy on wrinkles of Peptide-C ampoules by investigator clinical scoring based on Dynamical Atlas visual assessment (N = 40) and subject self-assessment questionnaires (N = 47). Study 3, an open clinical study, evaluated wrinkles by instrumental quantification with 3D fringe projection analysis (N = 40) and subject questionnaires (N = 51). RESULTS: The mean cell turnover was faster for skin treated with Peptide-C ampoules compared to untreated skin (17.1 days vs. 19.2 days; P < 0.0001). In study 2, after 28 days application of Peptide-C ampoules, clinical grading of crow's-feet wrinkles, forehead wrinkles and nasolabial folds decreased by 9%, 11% and 5%, respectively (all P < 0.05 vs baseline). Of 47 subjects, 77%, 64% and 79% indicated their skin seemed smoothed out, fine lines were less visible, and skin complexion was more radiant, respectively. In study 3, the number of wrinkles decreased by 11.5% after 29 days application of Peptide-C ampoules vs baseline (P < 0.05) and 65% of subjects responded the fine lines were less visible. CONCLUSION: This formulation of a combination of anti-ageing ingredients in ampoules, allowing a minimalist formula, showed significant results on improving facial wrinkles and radiance.

OBJECTIF: La vitamine C et les peptides sont régulièrement utilisés dans les produits dermocosmétiques mais il existe peu d'études cliniques sur l'efficacité des formulations sur les signes du vieillissement cutané du visage. Trois études cliniques ont évalué l'efficacité d'une formule anti-âge contenant de la vitamine C naturelle (10%), des biopeptides (riz et lupin), de l'acide hyaluronique et de l'eau minéralisante volcanique de Vichy, dans un format d'ampoules en verre ambré, sans conservateur (ampoules Peptide-C). MÉTHODES: Une première étude a comparé par la technique de chlorure de Dansyl le renouvellement cellulaire avec la formulation ampoules Peptide-C et la peau non traitée chez 32 sujets féminins. La seconde étude, en ouvert, a évalué l'efficacité clinique sur les rides des ampoules Peptide-C en se reposant sur les Atlas Dynamiques (N=40) et les questionnaires d'auto-évaluation des sujets (N=47). La troisième étude, ouverte, a évalué les rides par quantification instrumentale avec l'analyse de projection de franges 3D (N=40) et les questionnaires d'autoévaluation des sujets (N=51). RÉSULTATS: Le renouvellement cellulaire était plus rapide pour la peau traitée avec des ampoules de Peptide-C comparées à la peau non traitée (17.1 jours contre 19.2 jours ; p<.0001). Dans l'étude 2, après 28 jours d'application des ampoules Peptide-C, l'évaluation clinique des rides de la patte d'oie, du front et des plis naso-labiaux a montré une amélioration de 9 %, 11 % et 5 %, respectivement (tous p<0,05 vs baseline). Sur 47 sujets, 77%, 64% et 79% ont indiqué que leur peau semblait respectivement lissée, que les ridules étaient moins visibles et que le teint de la peau était plus radieux. Dans l'étude 3, le nombre de rides a diminué de 11,5 % après 29 jours d'application des ampoules Peptide-C par rapport à la baseline (p<0,05) et 65 % des sujets ont répondu que les ridules étaient moins visibles. CONCLUSION: Cette combinaison d'ingrédients anti-âge dans un format d'ampoules, et une formulation minimaliste, a montré des résultats significatifs sur l'amélioration des rides faciales et de l'éclat du teint.

Daylight photodynamic therapy with methyl aminolevulinate cream is as effective as conventional photodynamic therapy with blue light in the treatment of actinic keratosis: a controlled randomized intra-individual study.

BACKGROUND: We know the efficacy of daylight phototherapy dynamic (DL-PDT) in the treatment of actinic keratosis (AK). But the almost studies have compared daylight with red light using methyl aminolevulinate cream and not with blue light. PDT with blue light is another conventional PDT that is effective in the treatment of AKs. OBJECTIVES: The aim of this study is to assess the efficacy and the safety of DL-PDT vs. PDT in blue light in the treatment of AKs. METHODS: This randomized, controlled, intra-individual efficacy and safety study enrolled 26 subjects. AKs on the face/scalp were treated once, with DL-PDT on one side and c-PDT on the contralateral side. Primary endpoints for DL-PDT at week 12 were efficacy with clearance of AKs and safety with assessment of pain. Lesions with complete response 12 weeks after one treatment session were followed until week 24. RESULTS: More than 1000 AK were studied. At week 12, the raw number of disappeared AK lesions at 3-month follow-up was 19.6 (±6.0) for DL-PDT and 20.0 (±6.9) for c-PDT with P = 0.8460 (90.5% vs. 94.2% of AK disappearance, respectively). The response was maintained at 6 months (90.0% and 94.6% of AK reduction, respectively). DL-PDT was nearly painless than c-PDT with light blue: 1.2 vs. 5.1, respectively (P < 0.0001). CONCLUSIONS: Daylight-PDT seems as effective as c-PDT with light blue and DL-PDT is less painful. The response of DL-PDT was sustainable until 6 months.

The conventional protocol vs. a protocol including illumination with a fabric-based biophotonic device (the Phosistos protocol) in photodynamic therapy for actinic keratosis: a randomized, controlled, noninferiority clinical study.

BACKGROUND: Topical photodynamic therapy (PDT) using methyl aminolaevulinate is a noninvasive treatment option suitable to treat clinical and subclinical actinic keratosis (AK) over a large area (field cancerization). The most widely used, conventional protocol in Europe includes illumination with a red-light lamp. This illumination commonly causes pain, and patients often cannot complete the treatment. OBJECTIVES: The aims of this paper are twofold. The first aim is to introduce a novel protocol, the Phosistos protocol (P-PDT), which includes illumination with a fabric-based biophotonic device. The second and major aim is to assess the noninferiority, in terms of efficacy for PDT of AK, of P-PDT compared with the conventional protocol (C-PDT). METHODS: A randomized, controlled, multicentre, intraindividual clinical study was conducted. Forty-six patients with grade I-II AK of the forehead and scalp were treated with P-PDT on one area (280 AK lesions) and with C-PDT on the contralateral area (280 AK lesions). The primary end point was the lesion complete response (CR) rate at 3 months, with an absolute noninferiority margin of -10%. Secondary end points included pain scores, incidence of adverse effects and cosmetic outcome. RESULTS: Three months following treatment, the lesion CR rate of P-PDT was noninferior to that of C-PDT (79·3% vs. 80·7%, respectively; absolute difference -1·6%; one-sided 95% confidence interval -4·5% to infinity). The noninferiority of P-PDT to C-PDT in terms of the lesion CR rate remained at the 6-month follow-up (94·2% vs. 94·9%, respectively; absolute difference -0·6%; one-sided 95% confidence interval -2·7% to infinity). Moreover, the pain score at the end of illumination was significantly lower for P-PDT than for C-PDT (mean ± SD 0·3 ± 0·6 vs. 7·4 ± 2·3; P < 0·001). CONCLUSIONS: P-PDT is noninferior to C-PDT in terms of efficacy for treating AK of the forehead and scalp and resulted in much lower pain scores and fewer adverse effects. What's already known about this topic? Topical photodynamic therapy using methyl aminolaevulinate is effective for treating actinic keratosis. In Europe, the conventional protocol involves illumination with a red-light lamp. Unfortunately, pain is often experienced by patients undergoing this protocol. An alternative protocol that uses daylight illumination has recently been shown to be as effective as the conventional protocol while being nearly painless. However, this alternative protocol can be conducted only in suitable weather conditions. What does this study add? The Phosistos protocol is demonstrated to be as effective as the conventional protocol, nearly as painless as the daylight protocols and suitable year round for treatment of actinic keratosis.

The role of exposome in acne: results from an international patient survey.

BACKGROUND: Acne severity and its response to treatment may be influenced by internal and external factors: the exposome. OBJECTIVES: The aim of this international real-life survey was to assess the most involved exposome factors in acne. METHODS: Eleven thousand individuals, aged between 15 and 39 years, with clinically confirmed acne or without acne, defined by age, gender and prevalence, were invited to participate in an Internet survey of 63 questions in order to assess the frequency of identified acne exposome factors. RESULTS: Data from 6679 questionnaires were used for statistical analysis purposes: 2826 from the acne group and 3853 from the control group. Nibbling, consumption of dairy products, sweets, alcohol or whey proteins, as well as exposure to pollution, stress, certain mechanical factors and humid or hot weather or sun exposure, were significantly (all P ≤ 0.05) more frequently reported for the acne group than for the control group. This was not the case for tobacco consumption. Data regarding the impact of cannabis consumption were insufficient for drawing any conclusions. CONCLUSIONS: Data from this international, anonymized Internet questionnaire conducted with more than almost 6700 participants add new arguments to assumptions made that certain exposome factors have an impact on acne. Nutrition, pollution, stress and harsh skincare, as well as climate and sun exposure may be considered the most frequent factors related to acne.

Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light-emitting, fabric-based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp.

BACKGROUND: Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light-emitting, fabric-based device was developed. OBJECTIVES: This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp. METHODS: A monocentric, randomized, controlled, phase II clinical study was performed. Twenty-five patients with grade I-II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end-point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of -10% was used). The secondary end-points included patient-reported pain at the end of the irradiation. RESULTS: At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (66·0% vs. 59·1%, respectively; absolute difference, 6·9%; 95% confidence interval -0·6% to 14·5%). Patient-reported pain was significantly lower with the Flexitheralight protocol than with the conventional protocol (mean ± SD: 0·4 ± 0·6 vs. 5·0 ± 2·6; P < 0·0001). CONCLUSIONS: The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp.

Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial.

BACKGROUND: Daylight photodynamic therapy (DL-PDT) of actinic keratosis (AK) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c-PDT), using methyl aminolevulinate (MAL) cream. OBJECTIVES: To demonstrate the efficacy and safety of DL-PDT vs. c-PDT in treating mild facial/scalp AK. MATERIALS AND METHODS: This 24-week randomized, controlled, investigator-blinded, multicentre, intra-individual efficacy (non-inferiority) and safety (superiority regarding pain) study enrolled 100 subjects. AKs on the face/scalp were treated once, with DL-PDT on one side and c-PDT on the contralateral side. Primary end points for DL-PDT at week 12 were efficacy [non-inferiority regarding complete lesion response (mild AK)] and safety (superiority regarding subject's assessment of pain). Lesions with complete response 12 weeks after one treatment session were followed until week 24. The safety evaluation included incidence of adverse events. Subject satisfaction was classified using a questionnaire. RESULTS: At week 12, the complete lesion response rate with DL-PDT was non-inferior to c-PDT (89·2% vs. 92·8%, respectively; 95% confidence interval -6·8 to -0·3), confirmed by intention-to-treat analysis. Additionally, regardless of the treatment used, 96% of mild lesions were maintained in complete response 24 weeks after the PDT session. For DL-PDT, subject-reported pain was significantly lower (0·8 vs. 5·7, respectively; P < 0·001), with better tolerability and significantly higher subject satisfaction regarding convenience and outcome. CONCLUSIONS: Daylight-mediated PDT was not inferior in efficacy to Metvix c-PDT (mild AK response rate), better tolerated, nearly painless and more convenient for patients.

Photodynamic therapy for actinic keratosis in organ transplant patients.

BACKGROUND: The incidence of actinic keratoses (AK) and non-melanoma skin cancer (NMSC) in organ transplant recipients (OTRs) is significantly higher than in immunocompetent patients. Rates of progression and recurrence following treatment are higher too, in part due to the effects of the immunosuppressant drugs. Conventional therapies for AK, using curettage, cryotherapy, surgical excision, topical therapies and photodynamic therapy (PDT), are often less effective, and may be inappropriate, for treating the greater numbers and extent of lesions in OTRs. Moreover, there are no specific protocols for treating this patient population that take into account the need for more frequent treatment and the increased pain associated with treating larger areas. OBJECTIVES: Recently, a pan-European group of dermatologists with expertise in this area met to share current best practice in PDT for the treatment of AK in OTRs. METHODS: The group identified areas where PDT currently is not meeting the needs of these patients and discussed how these gaps might be addressed. RESULTS/CONCLUSIONS: This position article summarizes those discussions and makes recommendations concerning a standardized protocol for treating OTRs, for a large randomized controlled trial to provide robust data on safety, efficacy and optimal pain control, and to provide pharmaco-economics data that can be used to support extended reimbursement in this patient group. The authors also recommend a second clinical trial to further investigate induced immunosuppression with PDT in healthy volunteers.