Staphylococcus epidermidis isolates from atopic or healthy skin have opposite effect on skin cells: potential implication of the AHR pathway modulation.

Introduction: Staphylococcus epidermidis is a commensal bacterium ubiquitously present on human skin. This species is considered as a key member of the healthy skin microbiota, involved in the defense against pathogens, modulating the immune system, and involved in wound repair. Simultaneously, S. epidermidis is the second cause of nosocomial infections and an overgrowth of S. epidermidis has been described in skin disorders such as atopic dermatitis. Diverse isolates of S. epidermidis co-exist on the skin. Elucidating the genetic and phenotypic specificities of these species in skin health and disease is key to better understand their role in various skin conditions. Additionally, the exact mechanisms by which commensals interact with host cells is partially understood. We hypothesized that S. epidermidis isolates identified from different skin origins could play distinct roles on skin differentiation and that these effects could be mediated by the aryl hydrocarbon receptor (AhR) pathway. Methods: For this purpose, a library of 12 strains originated from healthy skin (non-hyperseborrheic (NH) and hyperseborrheic (H) skin types) and disease skin (atopic (AD) skin type) was characterized at the genomic and phenotypic levels. Results and discussion: Here we showed that strains from atopic lesional skin alter the epidermis structure of a 3D reconstructed skin model whereas strains from NH healthy skin do not. All strains from NH healthy skin induced AhR/OVOL1 path and produced high quantities of indole metabolites in co-culture with NHEK; especially indole-3-aldehyde (IAld) and indole-3-lactic acid (ILA); while AD strains did not induce AhR/OVOL1 path but its inhibitor STAT6 and produced the lowest levels of indoles as compared to the other strains. As a consequence, strains from AD skin altered the differentiation markers FLG and DSG1. The results presented here, on a library of 12 strains, showed that S. epidermidis originated from NH healthy skin and atopic skin have opposite effects on the epidermal cohesion and structure and that these differences could be linked to their capacity to produce metabolites, which in turn could activate AHR pathway. Our results on a specific library of strains provide new insights into how S. epidermidis may interact with the skin to promote health or disease.

Selenium disulfide: a key ingredient to rebalance the scalp microbiome and sebum quality in the management of dandruff.

BACKGROUND: Dandruff is a chronic and relapsing scalp condition characterized by flaky scalp. Environmental and host factors (exposome) may alter the sebaceous gland activity, sebum composition, epidermal barrier function, and scalp microbiome balance, resulting in dandruff. Selenium disulfide (SeS2) improves the clinical signs of dandruff. OBJECTIVES: To investigate the mode of action of SeS2 shampoo during treatment and relapse phases. MATERIALS & METHODS: Two single-center studies assessed dandruff severity, subjective efficacy perception, microbial balance, microbiota diversity and sebum lipids. RESULTS: SeS2 significantly (p≤0.01) reduced scaling and led to a significant decrease of Malassezia and Staphylococcus spp. counts in both lesional and non-lesional areas, compared to the vehicle at D28 returning to baseline levels at D56. Cutibacterium spp. levels were not different between the SeS2 and the vehicle treatment groups but had significantly increased with SeS2 (p<0.001) in the lesional zone at D56. The ratio Malassezia spp./Cutibacterium spp. decreased significantly in lesional zones compared to baseline levels, at both D28 and D35 (p<0.001). The total squalene content significantly increased (p<0.05), whereas peroxided squalene had significantly decreased by almost 50% at D31. The ratio triglycerides/free fatty acids significantly (p<0.0001) increased, almost 5-fold, between D0 and D31. SeS2 shampoo was very well tolerated. CONCLUSION: SeS2 is beneficial in scalp dandruff, even after treatment interruption. It is well tolerated, rebalances the equilibrium between the main bacterial and fungal populations, and improves sebum quality.

Benefits of the Dermocosmetic Mineral 89 Probiotic Fractions Adjunct to Topical Retinoids for Anti-Aging Benefits.

Purpose: Tretinoin is a topical gold standard for photoaging treatment. However, patient adherence can be impaired by local tolerability in the first 1-2 weeks of treatment. Mineral 89 Probiotic Fractions® (M89PF) containing Vichy volcanic mineralizing water®, probiotic fractions, hyaluronic acid, niacinamide and tocopherol was developed to fulfill the need for adjunctive products that can reinforce skin barrier and manage retinoid induced irritation. Patients and Methods: The study included 38 women, aged 44-60 years, phototype II-VI, applying 0.025% tretinoin gel once nightly for 84 days. For 28 days, one hemi face was treated with M89PF and sunscreen SPF 50+ while other hemi face received sunscreen only. Then, M89PF application was changed to full face. Evaluations were performed at days 0, 7, 28 and 84. Erythema, dryness, fine lines, skin tone, radiance and pore appearance were assessed by a dermatologist. Tolerability was evaluated through self-assessment questionnaire. Skin hydration levels, inflammatory and oxidative stress biomarkers were analyzed by immunological assay: Interleukin(IL)-8, IL1-alpha, IL1-Receptor Antagonist (IL-1Ra), Prostaglandin E2 (PGE2), Catalase and Superoxide Dismutase (SOD). Results: Hemiface analysis showed that erythema, fine lines, skin tone, radiance, pore appearance, hydration, tightness, dryness, burning, itching and stinging sensations were improved (p<0.05) on the M89PF side. At full face analysis on D84, erythema, fine lines, skin tone, radiance and pore appearance were improved compared to D0 (p<0.001). Tightness, dryness, burning, itching and stinging were reduced when compared to D7 (p<0.05). Dermatology Life Quality Index (DLQI) and Skindex 16 showed improvement in quality of life (p<0.05). IL-1RA increased at D28 (p=0.003) and PGE2 decreased at D28 and D84 compared to D0 (p<0.01). Conclusion: M89PF reduced retinoid induced irritation with a good tolerability profile and, used as an adjunct to topical tretinoin, significantly improved skin hydration, erythema, fine lines, skin tone, radiance and pore appearance.

Malassezia restricta-mediated Lipoperoxidation: A Novel Trigger in Dandruff.

Dandruff is a common scalp disorder with multiple microbial and host-related factors contributing to its aetiology, including alterations in scalp sebum. Despite existing evidence that the yeast Malassezia restricta plays a key role in the onset of dandruff, the interplay of these factors is poorly understood. Recently, squalene monohydroperoxide and malondialdehyde were established as biomarkers of dandruff-afflicted scalp, highlighting the role of sebum lipoperoxidation in the triggering and maintenance of dandruff, although its mechanism of action is unknown. The current study provides evidence that M. restricta mediates sebum peroxidation, leading to production of squalene monohydroperoxide and malondialdehyde. Furthermore, in vitro data show that these lipoperoxidation products act on epidermal cells and alter the skin barrier. These results support the role of Malassezia restricta-induced lipoperoxides as triggers of dandruff, which suggests that blocking their production could be a novel anti-dandruff treatment approach.

A multi-study analysis enables identification of potential microbial features associated with skin aging signs.

Introduction: During adulthood, the skin microbiota can be relatively stable if environmental conditions are also stable, yet physiological changes of the skin with age may affect the skin microbiome and its function. The microbiome is an important factor to consider in aging since it constitutes most of the genes that are expressed on the human body. However, severity of specific aging signs (one of the parameters used to measure "apparent" age) and skin surface quality (e.g., texture, hydration, pH, sebum, etc.) may not be indicative of chronological age. For example, older individuals can have young looking skin (young apparent age) and young individuals can be of older apparent age. Methods: Here we aim to identify microbial taxa of interest associated to skin quality/aging signs using a multi-study analysis of 13 microbiome datasets consisting of 16S rRNA amplicon sequence data and paired skin clinical data from the face. Results: We show that there is a negative relationship between microbiome diversity and transepidermal water loss, and a positive association between microbiome diversity and age. Aligned with a tight link between age and wrinkles, we report a global positive association between microbiome diversity and Crow's feet wrinkles, but with this relationship varying significantly by sub-study. Finally, we identify taxa potentially associated with wrinkles, TEWL and corneometer measures. Discussion: These findings represent a key step towards understanding the implication of the skin microbiota in skin aging signs.

Combining the use of two non-invasive instruments to confirm that a formula can improve skin luminance while respecting constitutive melanogenesis.

INTRODUCTION: Skin radiance products achieve perceivable benefits with different sort of mechanism of action. AIMS: To use two non-invasive instrumental devices to evaluate the effectiveness of a cosmetic formula designed to improve skin reflectance while respecting skin integrity. PATIENTS AND METHODS: Subjects (N = 43) aged 18-50 years old had healthy skin of phototype V-VI and Individual Typology Angle between -10° and -50°. The treatment was applied twice weekly for 4 weeks on a delineated area of the back, and an adjacent area was left untreated. Instrumental and clinical scoring assessments of treated and untreated skin were performed at baseline and Day 26. RESULTS: Between baseline and Day 26, reflectance (Delta L*) increased by 1.27 points and was considered as clinically relevant. Dermatologist clinical scoring of radiance significantly improved from 2.6 to 3.6 after 4 weeks of treatment and the Skin Color Chart Clarity level significantly decreased from a score of 15.5 to 14.3, representing a skin reflectance improvement. Conversely, the change between baseline and Day 26 in Mexameter Melanin Density was not clinically different for treated skin versus untreated skin (difference of 2.54). At Day 26, changes from baseline for Mexameter Melanin Density and Delta L* parameters appeared to be uncorrelated (r = -0.036). CONCLUSIONS: This combination of two non-invasive devices can be useful to confirm that a product can modulate skin reflectance without modifying constitutive pigmentation. The formula tested in this study did not interfere with constitutive melanogenesis.

Advances in Microbiome-Derived Solutions and Methodologies Are Founding a New Era in Skin Health and Care.

The microbiome, as a community of microorganisms and their structural elements, genomes, metabolites/signal molecules, has been shown to play an important role in human health, with significant beneficial applications for gut health. Skin microbiome has emerged as a new field with high potential to develop disruptive solutions to manage skin health and disease. Despite an incomplete toolbox for skin microbiome analyses, much progress has been made towards functional dissection of microbiomes and host-microbiome interactions. A standardized and robust investigation of the skin microbiome is necessary to provide accurate microbial information and set the base for a successful translation of innovations in the dermo-cosmetic field. This review provides an overview of how the landscape of skin microbiome research has evolved from method development (multi-omics/data-based analytical approaches) to the discovery and development of novel microbiome-derived ingredients. Moreover, it provides a summary of the latest findings on interactions between the microbiomes (gut and skin) and skin health/disease. Solutions derived from these two paths are used to develop novel microbiome-based ingredients or solutions acting on skin homeostasis are proposed. The most promising skin and gut-derived microbiome interventional strategies are presented, along with regulatory, safety, industrial, and technical challenges related to a successful translation of these microbiome-based concepts/technologies in the dermo-cosmetic industry.

Continuous clinical improvement of mild-to-moderate seborrheic dermatitis and rebalancing of the scalp microbiome using a selenium disulfide-based shampoo after an initial treatment with ketoconazole.

OBJECTIVE: Scalp seborrheic dermatitis (SD) is a chronic, relapsing, and inflammatory scalp disease. Studies indicate a global bacterial and fungal microbiota shift of scalp SD, as compared to healthy scalp. Ketoconazole and selenium disulfide (SeS2 ) improve clinical signs and symptoms in both scalp dandruff and SD. AIM: The main objective of this study was to investigate the changes in the scalp microbiota diversity and counts in subjects with scalp SD during a two-phase treatment period. MATERIAL AND METHODS: The scalp microbiota and clinical efficacy were investigated in 68 subjects with mild-to-moderate scalp SD after an initial one-month treatment with 2% ketoconazole, and after a 2-month maintenance phase, either with a 1% SeS2 -based shampoo or its vehicle. RESULTS: Thirty one subjects in the active and 37 subjects in the vehicle group participated. Ketoconazole provided an improvement of clinical symptoms (adherent (-1.75 p < 0.05), non-adherent (-1.5, p < 0.05)) flakes and erythema (scores 1.67-0.93, p < 0.001), in an increased fungal diversity and in a significant (p < 0.005) decrease of Malassezia spp. SeS2 provided an additional clinical improvement (-0.8; p = 0.0002 and -0.7; p = 0.0081 for adherent and non-adherent flakes, respectively, at Day 84) compared to the vehicle associated with a low Malassezia spp. count and an additional significant (p < 0.001) decrease of the Staphylococcus spp. level. CONCLUSION: Selenium disulfide provides an additional benefit on the scalp microbiota and in clinical symptoms of SD and dandruff after treatment with ketoconazole. The results confirm the role of Staphylococcus spp. in scalp SD and open possible perspectives for preventing relapses.

Vitreoscilla filiformis Extract for Topical Skin Care: A Review.

The term probiotic has been defined by experts as live microorganisms, which when administered in adequate amounts, confer a health benefit on the host. Probiotics are, thus, by definition, live microorganisms, and the viability of probiotics is a prerequisite for certain benefits, such as the release of metabolites at the site or adhesion properties, for example. However, some semi-active or non-replicative bacterial preparations may retain a similar activity to the live forms. On cosmetic, lysates or fractions are generally used. Topically applied Vitreoscilla filiformis extract has shown to have some similar biological activity of probiotics in the gut, for example, regulating immunity by optimisation of regulatory cell function, protecting against infection, and helping skin barrier function for better recovery and resistance. Due to their mode of action and efficacy, V. filiformis extract (lysate including membrane and cytosol) may be considered as non-replicative probiotic fractions, and this review article presents all its properties.

Vitamin C Prevents Ultraviolet-induced Pigmentation in Healthy Volunteers: Bayesian Meta-analysis Results from 31 Randomized Controlled versus Vehicle Clinical Studies.

Background: Repeated nonextreme sun exposures induce skin pigmentation by increasing melanin production and by oxidizing preexisting melanin and melanin precursors. This leads to skin disorders and skin color heterogeneity such as hyperpigmented spots. Objective: We assessed 31 randomized, controlled clinical trials to determine the potential of vitamin C to limit ultraviolet (UV) daylight-induced pigmentation, considering dose response and different skin type populations (Caucasian and Chinese). Materials and Methods: Thirty-one intraindividual, randomized, controlled clinical trials involving Caucasian and Chinese subjects (15-35 healthy male or female volunteers per study, 741 total volunteers) 18 to 50 years of age with Phototype III and individual typology angle (ITA) value between 28 and 49 degrees were analyzed. The 31 studies assessed the potential of vitamin C (formulated with the copolymer Styrène-Anhydride Maléique [SMA]) to decrease pigmentation induced by UV daylight exposure. Results were combined using a Bayesian meta-analysis to provide probabilistic evidence of the effects of vitamin C by dose and population. Results: Vitamin C was effective in reducing pigmentation induced by UV daylight-simulated expositions (4 days at 0.75 Individual Minimal Erythemal Dose [MEDi]) in a dose-dependent manner. During the depigmentation phase, no additive value was provided by the vitamin C, suggesting that the lightening properties described in the literature for vitamin C correspond to an antipigmenting quality rather than a depigmenting effect. Conclusion: Vitamin C is a valuable and safe dermocosmetic antipigmenting compound with a strong effect at 10% possibly useful in preventing signs of photoaging.

Differential involvement of glycans in the binding of Staphylococcus epidermidis and Corynebacterium spp. to human sweat.

Sweat is a secretory fluid that can be a source of unpleasant body odour due to interaction of resident bacteria with sweat components. Identification of glycoproteins in sweat suggests that protein-conjugated glycans may act as binding epitopes for bacteria, as found in other secretory fluids such as human milk, tears and saliva which help to protect epithelial surfaces from infection. We conducted proteomic and glycomic analysis of sweat to reveal an abundance of glycoproteins, predominantly carrying bi-antennary sialylated N-glycans with or without fucose. A fluorescent plate assay was used to determine whether glycans on sweat proteins provide binding epitopes for odour-producing skin commensals Staphylococcus epidermidis and Corynebacterium. Sialic acid and fucose were found to be important binding epitopes for S. epidermidis 3-22-BD-6, a strain recently isolated from human sweat, whereas fucose (but not sialic acid) contributed to the binding of Type strain S. epidermidis ATCC 12228. In contrast, our results indicate that sweat N-glycans do not provide binding epitopes for Corynebacterium. Synthetic sugar mimics of Lewis blood group antigens were investigated as potential inhibitors of the binding of S. epidermidis 3-22-BD-6 to sweat. Pre-incubation of the bacterium with LeB, LeX, LeY and sLeX (pentaose) resulted in a significant reduction in sweat protein adhesion indicating that terminal fucose is a key binding epitope, particularly when linked to a Type 2 chain (Galß1-4GlcNAc) configuration (LeY). Our results form an impetus for future studies seeking to elucidate the role of glycans in sweat associated malodour, with possible implications for cosmetic and medical fields.

Identification of chronological and photoageing-associated microRNAs in human skin.

MicroRNAs are short non-coding RNAs that play key roles in regulating biological processes. In this study, we explored effects of chronological and photoageing on the miRNome of human skin. To this end, biopsies were collected from sun-exposed (outer arm, n = 45) and sun-protected (inner arm, n = 45) skin from fair-skinned (phototype II/III) healthy female volunteers of three age groups: young, 18-25 years, middle age, 40-50 years and aged, > 70 years. Strict inclusion criteria were used for photoageing scoring and for chronological ageing. Microarray analysis revealed that chronological ageing had minor effect on the human skin miRNome. In contrast, photoageing had a robust impact on miRNAs, and a set of miRNAs differentially expressed between sun-protected and sun-exposed skin of the young and aged groups was identified. Upregulation of miR-383, miR-145 and miR-34a and downregulation of miR-6879, miR-3648 and miR-663b were confirmed using qRT-PCR in sun-exposed skin compared with sun-protected skin. qRT-PCR analysis revealed that miR-383, miR-34a and miR-134 were differentially expressed in all three age groups both in chronological and photoageing, suggesting a synergetic effect of intrinsic and extrinsic ageing on their expression. In conclusion, our study identifies a unique miRNA signature which may contribute to skin ageing.

Efficacy of Glucosamine Sulphate in Skin Ageing: Results from an ex vivo Anti-Ageing Model and a Clinical Trial.

BACKGROUND: Glucosamine sulphate (GS) is essential in the biosynthesis of glycolipids, glycoproteins, glycosaminoglycans (GAGs), hyaluronate, and proteoglycans. Connective tissues primarily contain collagen and proteoglycans and play an important role in skin ageing. OBJECTIVE: The objectives were to assess ex vivo the impact of GS on skin ageing parameters and in vivo the effect of GS on the skin physiology of mature healthy volunteers after oral intake. METHODS: The impact of GS on skin ageing was assessed ex vivo via different immunohistochemical assays and histology and via a clinical study using biopsies. Modulation of selected skin physiology markers was assessed by real-time quantitative PCR on skin punch biopsies obtained from 8 healthy >50-year-old women having ingested GS 250 mg once daily for 8 weeks. RESULTS: Ex vivo, GS significantly (all p ≤ 0.02) increased the expression of CD44 and collagen type IV, the epidermis GAG level, and collagen type I synthesis. After 8 weeks of oral GS administration, a significantly increased expression was observed at the mRNA level for vimentin, fibromodulin, biglycan, xylosyl transferase, hyaluronan synthase, collagen types I and III, bone morphogenic protein-1, and decorin (all p ≤ 0.05). CONCLUSION: Both experiments showed that GS has a positive effect on epidermal and dermal markers associated with age.

Anandamide Suppresses Proinflammatory T Cell Responses In Vitro through Type-1 Cannabinoid Receptor-Mediated mTOR Inhibition in Human Keratinocytes.

The endocannabinoid system comprises cannabinoid receptors 1 and 2 (CB1 and CB2), their endogenous ligands, anandamide (AEA) and 2-arachidonoylglycerol, and metabolic enzymes of these ligands. The endocannabinoid system has recently been implicated in the regulation of various pathophysiological processes of the skin that include immune competence and/or tolerance of keratinocytes, the disruption of which might promote the development of skin diseases. Recent evidence showed that CB1 in keratinocytes limits the secretion of proinflammatory chemokines, suggesting that this receptor might also regulate T cell dependent inflammatory diseases of the skin. In this article, we sought to investigate the cytokine profile of IFN-γ-activated keratinocytes, and found that CB1 activation by AEA suppressed production and release of signature TH1- and TH17-polarizing cytokines, IL-12 and IL-23, respectively. We also set up cocultures between a conditioned medium of treated keratinocytes and naive T cells to disclose the molecular details that regulate the activation of highly proinflammatory TH1 and TH17 cells. AEA-treated keratinocytes showed reduced an induction of IFN-γ-producing TH1 and IL-17-producing TH17 cells, and these effects were reverted by pharmacological inhibition of CB1 Further analyses identified mammalian target of rapamycin as a proinflammatory signaling pathway regulated by CB1, able to promote either IL-12 and IL-23 release from keratinocytes or TH1 and TH17 polarization. Taken together, these findings demonstrate that AEA suppresses highly pathogenic T cell subsets through CB1-mediated mammalian target of rapamycin inhibition in human keratinocytes. Thus, it can be speculated that the latter pathway might be beneficial to the physiological function of the skin, and can be targeted toward inflammation-related skin diseases.

Sweating the small stuff: Glycoproteins in human sweat and their unexplored potential for microbial adhesion.

There is increasing evidence that secretory fluids such as tears, saliva and milk play an important role in protecting the human body from infection via a washing mechanism involving glycan-mediated adhesion of potential pathogens to secretory glycoproteins. Interaction of sweat with bacteria is well established as the cause of sweat-associated malodor. However, the role of sweat glycoproteins in microbial attachment has received little, if any, research interest in the past. In this review, we demonstrate how recent published studies involving high-throughput proteomic analysis have inadvertently, and fortuitously, exposed an abundance of glycoproteins in sweat, many of which have also been identified in other secretory fluids. We bring together research demonstrating microbial adhesion to these secretory glycoproteins in tears, saliva and milk and suggest a similar role of the sweat glycoproteins in mediating microbial attachment to sweat and/or skin. The contribution of glycan-mediated microbial adhesion to sweat glycoproteins, and the associated impact on sweat derived malodor and pathogenic skin infections are unchartered new research areas that we are beginning to explore.

UV Radiation Induces the Epidermal Recruitment of Dendritic Cells that Compensate for the Depletion of Langerhans Cells in Human Skin.

UVR causes skin injury and inflammation, resulting in impaired immune function and increased skin cancer risk. Langerhans cells (LCs), the immune sentinels of the epidermis, are depleted for several days following a single UVR exposure and can be reconstituted from circulating monocytes. However, the differentiation pathways leading to the recovery of a normal pool of LCs is still unclear. To study the dynamic changes in human skin with UV injury, we exposed a cohort of 29 healthy human volunteers to a clinically relevant dose of UVR and analyzed sequential epidermal biopsies for changes in leukocyte and dendritic cell (DC) subsets. UV-induced depletion of CD1a(high) LC was compensated by sequential appearance of various epidermal leukocytes. CD14(+) monocytes were recruited as early as D1 post exposure, followed by recruitment of two inflammatory DC subsets that may represent precursors of LCs. These CD1a(low) CD207(-) and the heretofore unknown CD1a(low) CD207(+) DCs appeared at day 1 and day 4 post UVR, respectively, and were endowed with T-cell-activating properties similar to those of LCs. We conclude that recruitment of monocytes and inflammatory DCs appear as a physiological response of the epidermis in order to repair UVR-induced LC depletion associated with immune suppression.

Characterization of the major bacterial-fungal populations colonizing dandruff scalps in Shanghai, China, shows microbial disequilibrium.

Dandruff is a scalp disorder characterized by the formation of flaky white-yellowish scales due to an altered proliferation and differentiation status; a disrupted barrier function; a decrease in the level of hydration and of natural moisturizing factors (NMF) in the scalp, with a persistent and relapsing inflammatory condition. It was recently reported that an imbalance between bacterial and fungal species colonizing the scalp of French volunteers was associated with dandruff condition. The purpose of the present study was to analyze the major bacterial and fungal species present on the scalp surface of Chinese volunteers and to investigate possible region-related variation in the microbiota linked to dandruff condition. The data obtained from the Chinese populations were highly similar to those obtained in France, confirming that dandruff scalps are associated with a higher incidence of Malassezia restricta and Staphylococcal sp. The ratios of Malassezia to Propionibacterium and Propionibacterium to Staphylococcus were also significantly higher in the dandruff volunteers as compared to normal volunteers, suggesting that equilibrium between the major bacterial and fungal taxa found on the normal scalps is perturbed in the dandruff scalps. The main difference between the French and Shanghai subjects was in their Staphylococcal biota. The results obtained in China and in France suggest that targeting one particular Malassezia sp. by antifungals instead of using large spectrum antifungals and rebalancing the dandruff scalp microbiota could be common approach to improve dandruff condition in the two countries.

[Recommendations for Communication and Solicitation of Patients Potentially or Already Involved in Clinical Studies]. / Recommandations en matière de communication et de sollicitation de patients pouvant participer ou participant déjà à des études cliniques.

The active patient participation in clinical trials is key for a competitive clinical research. Given this, the Health Industry Physicians and Actors Association (AMIPS) has set up a working group to make communication recommendations towards patients. The group was made of patients, investigators and industry sponsors representatives. Efficacious communication is rarely obtained because it is not clear what is possible to do ethically and regulatory and because of technical and financial constraints. After having identified the expectations and limitations for every actor category, the group has summarized all types of communication, in a sort of tool box, before and during the whole of a study. The benefits and regulatory prerequisites such as the submission to the Ethical Committee and to the National Data Information and Freedom Commission (CNIL) as well as the practical feasibility are described for each tool.

[Not Available]. / Recommandations en matière de communication et de sollicitation de patients pouvant participer ou participant déjà à des études cliniques.

The active patient participation in clinical trials is key for a competitive clinical research. Given this, the Health Industry Physicians and Actors Association (AMIPS) has set up a working group to make communication recommendations towards patients. The group was made of patients, investigators and industry sponsors representatives. Efficacious communication is rarely obtained because it is not clear what is possible to do ethically and regulatory and because of technical and financial constraints. After having identified the expectations and limitations for every actor category, the group has summarized all types of communication, in a sort of tool box, before and during the whole of a study. The benefits and regulatory prerequisites such as the submission to the Ethical Committee and to the National Data Information and Freedom Commission (CNIL) as well as the practical feasibility are described for each tool.