The Needs of Patients with Psoriasis and Benefits of Apremilast in French Clinical Practice: Results from the Observational REALIZE Study.

INTRODUCTION: Real-world data on the needs of patients with psoriasis and patient-perceived benefits of apremilast are limited. We report such data from France. METHODS: The multicenter, observational REALIZE study was conducted in real-life clinical practice in France and enrolled patients with moderate-to-severe plaque psoriasis who had initiated apremilast per French reimbursement criteria in the 4 weeks preceding enrollment (September 2018-June 2020). Physician assessments and patient-reported outcomes (PROs) were collected at enrollment, 6 months, and 12 months. PROs included the Patient Benefit Index for skin diseases (PBI-S), Dermatology Life Quality Index (DLQI), and 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). The primary outcome was PBI-S ≥ 1 (minimum clinically relevant benefit) at month 6. RESULTS: Of 379 enrolled patients who received ≥ 1 dose of apremilast, most [n = 270 (71.2%)] remained on apremilast at 6 months and over half [n = 200 (52.8%)] persisted at 12 months. Patients reported the following treatment goals as most important (≥ 70% reported goal as "very important" in the Patient Needs Questionnaire): get better skin quickly, regain disease control, be healed of skin alterations, and have confidence in the therapy. Most patients persisting on apremilast achieved a PBI-S ≥ 1 at months 6 and 12 (91.6% and 93.8%, respectively). Mean (SD) DLQI decreased from 11.75 (6.69) at enrollment to 5.17 (5.35) and 4.18 (4.39) at months 6 and 12, respectively. Most patients (72.3%) reported moderate-to-severe pruritus at enrollment and no/mild pruritus at months 6 and 12 (78.8% and 85.9%, respectively). Mean (SD) TSQM-9 Global Satisfaction scores were 68.4 (23.3) and 71.7 (21.5) at months 6 and 12, respectively. Apremilast was well tolerated; no new safety signals were identified. CONCLUSIONS: REALIZE provides insights regarding the needs of patients with psoriasis and the patient-perceived benefits of apremilast. Patients who persisted on apremilast reported improvements in quality of life, high treatment satisfaction, and clinically relevant benefits. TRIAL REGISTRATION: NCT03757013.

Psoriasis is a chronic disease and can have a large impact on patients' quality of life. Patients often discontinue psoriasis treatments for a number of reasons, including side effects, ineffectiveness, and inconvenience. Apremilast (Otezla) is a twice-daily oral tablet for the treatment of moderate-to-severe plaque psoriasis. Data on the needs of patients with psoriasis and the patient-perceived benefits of psoriasis treatments, including apremilast, are limited. The REALIZE (Real Life Data for OTEZLA Evidence) study collected data from 379 patients with moderate-to-severe psoriasis receiving apremilast for up to 12 months in clinical practice across France. Patients completed questionnaires regarding their treatment goals, how well apremilast treatment met these goals, their quality of life, and their satisfaction with apremilast treatment. At the beginning of the study, patients reported getting better skin quickly, regaining control of their psoriasis, being healed of psoriatic lesions on their skin, and having confidence in their psoriasis treatment as their most important treatment goals. Over half of the patients continued apremilast for 12 months, with most reporting that apremilast successfully met their treatment needs. Patients also reported high satisfaction with apremilast and improved quality of life. The adverse events reported in the REALIZE study were similar to the known safety profile of apremilast. Our data show that apremilast is an effective, convenient, and well-tolerated treatment that improves the symptoms of psoriasis and meets patients' needs and expectations.

Moderate Psoriasis in Clinical Practice: French Expert Consensus Using a Modified Delphi Method.

INTRODUCTION: Despite the existence of multiple assessment scores for psoriasis severity, skin disease with limited skin lesions but significant impairment of quality of life can be difficult to classify, leading to under- or overtreatment. Our objective was to obtain consensus on clinical criteria to classify psoriasis severity in French clinical practice, with a focus on moderate disease, using a modified Delphi method. METHODS: A steering committee (SC) formulated a 22-item questionnaire to classify moderate psoriasis. An independent panel of French dermatologists indicated their level of agreement for each item using a 9-point Likert scale (round 1). Items without a strong consensus were modified and included in round 2. For each item, strong consensus was defined as at least 75% of scores ≥ 7 and median score ≥ 8; good consensus was defined as at least 75% of scores ≥ 7 or median score ≥ 8. RESULTS: Of 80 dermatologists who agreed to participate, 47 (59%) responded in round 1. All participants from round 1 responded in round 2. Fifteen (68%) items achieved strong consensus and four (18%) achieved good consensus. For psoriasis severity, several clinical dimensions assessed both by the physician (location, symptoms, temporality, previous treatments) and the patient (perception, physical and psychological impairment) obtained consensus. The following were considered sufficient to confirm that psoriasis is at least at a moderate stage: limited involvement but with an impact on patient/family quality of life; involvement of a special area; presence of uncontrolled symptoms (scaling, bleeding, pruritus, insomnia); accumulation of mild intensity symptoms; presence of burdensome onychodystrophy; failure of well-applied topical treatments. There was strong consensus that recognition of moderate psoriasis should lead to reassessment of topical treatments. CONCLUSION: Our modified Delphi panel suggests detailed criteria to help physicians classify patients with psoriasis which is at least at a moderate stage, which could, in turn, improve treatment in these patients.

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.

A method to assess the protective efficacy of sunscreens against visible light-induced pigmentation.

BACKGROUND: Until now, photoprotection of human skin has involved the development of sunscreens effective in the ultraviolet (UV) domain. During the last ten years, several studies have shown that besides the well-known damaging effects of UV, visible (400-700 nm) and even infrared light (> 700 nm) can induce damage which contributes to photoaging. Furthermore, many photodermatoses are also known to be triggered by visible light (VL). OBJECTIVE/METHOD: An in vivo method is proposed to assess the protective efficacy of sunscreens in the VL domain. This method is based on the intensity of pigmentation induced by four repeated daily doses of VL, each equivalent to about one hour of midday sun. Exposures are performed using a solar simulator (xenon lamp) equipped with appropriate filters, and pigmentation is measured both clinically and by chromametry. Three commercially available sunscreens designed to protect in the visible range were evaluated. RESULTS: The results indicate that the VL-induced pigmentation was already significantly detectable visually and by chromametry 24 hours after the first exposure on the unprotected zone. Two products with moderate protective activity could be differentiated from the untreated zone from Day 3 to Day 5 and were also significantly less effective than a third tested product within the same study period. CONCLUSION: The method is simple, based on a clinical end point of VL-induced skin pigmentation, and can be performed within a 5-day period. It allows discrimination between products of different protective capacities. VL protection factor is also discussed.

The skin aging exposome.

The term "exposome" describes the totality of exposures to which an individual is subjected from conception to death. It includes both external and internal factors as well as the human body's response to these factors. Current exposome research aims to understand the effects all factors have on specific organs, yet today, the exposome of human skin has not received major attention and a corresponding definition is lacking. This review was compiled with the collaboration of European scientists, specialized in either environmental medicine or skin biology. A comprehensive review of the existing literature was performed using PubMed. The search was restricted to exposome factors and skin aging. Key review papers and all relevant, epidemiological, in vitro, ex vivo and clinical studies were analyzed to determine the key elements of the exposome influencing skin aging. Here we propose a definition of the skin aging exposome. It is based on a summary of the existing scientific evidence for the role of exposome factors in skin aging. We also identify future research needs which concern knowledge about the interaction of distinct exposomal factors with each other and the resulting net effects on skin aging and suggest some protective measures.

Cutaneous lesions caused by mechanical injury.

BACKGROUND: To date, the term 'acne mechanica' defines different cutaneous lesions caused by mechanical injury. Objective: To re-define the spectrum of cutaneous lesions caused by mechanical injury by determining their clinical and histological characteristics, to discuss and identify triggering and pathophysiologic elements. METHODS: Clinical, histological and pathophysiological differences of 135 published cases of acne mechanica were analysed and compared to cases provided from our clinics. RESULTS AND CONCLUSIONS: Mechanical factors cause 2 types of mainly inflammatory cutaneous lesions: one presents with inflammatory papules, open comedones or has no comedonal lesions.We propose using the term 'folliculitis mechanica'. The second type corresponds to a flare-up of acne in areas prone to the condition. These lesions present the typical clinical and histological features of acne vulgaris, comprising inflammatory and retentional lesions. Treatment may include topical products, including adjunctive care for reconstruction of the cutaneous barrier and the microbiome. Conventional acne medication should be used in cases of acne flare-up.

A double-blind randomized study comparing the association of Retinol and LR2412 with tretinoin 0.025% in photoaged skin.

INTRODUCTION: Topical tretinoin is considered the gold standard to treat photoaged skin, but it is associated with side effects and only available upon prescription. AIM OF THE STUDY: To compare the efficacy, tolerance, and perception of a fixed proprietary combination (Retinol 0.2%/LR2412 2%) vs. tretinoin 0.025% cream in women with photoaged skin. MATERIAL/METHODS: In this randomized, parallel, double-blind, controlled clinical study, women applied to the entire face for 3 months in the morning a SPF 50 sunscreen and in the evening either the association of Retinol 0.2%/LR2412 2% or tretinoin 0.025%. Clinical and instrumental parameters were assessed at days 0, 28, 56, and 84. Subject perception of the efficacy, tolerance and cosmeticity of the tested products were assessed at days 28, 56, and 84. RESULTS: A total of 120 women (60 to Retinol 0.2%/LR2412 2% cream and 60 to tretinoin 0.025% cream) were included in the study. Both products improved considerably wrinkles, mottled pigmentation, pores, and global photodamage. No statistically significant differences were noted between Retinol 0.2%/LR2412 2% cream and tretinoin 0.025% cream. Adverse effects were mostly graded mild. Overall, Retinol 0.2%/LR2412 2% cream was better tolerated than tretinoin 0.025% cream. At all visits, subject perception of the association of Retinol 0.2%/LR2412 2% was either comparable to or better than tretinoin 0.025% cream. CONCLUSION: The treatment outcome of Retinol 0.2%/LR2412 2% cream does not differ from the one of tretinoin 0.025% cream. Clinical results were not statistically different. Furthermore, Retinol 0.2%/LR2412 2% cream is better tolerated and better perceived by women used to rejuvenation procedures.

A new sunscreen application technique to protect more efficiently from ultraviolet radiation.

BACKGROUND: UV radiation protection is an important health issue. Sophisticated sunscreen formulations have been developed to improve compliance. However, sunscreen is still inadequately applied, leaving large body areas without effective protection. AIM: This study aims to validate a newly developed sunscreen application technique for adults and children. METHODS: Fifty-eight volunteers were recruited to participate in a monocenter, intraindividual, sequential, comparative study. The covering potential of their currently used sunscreen application technique and of a newly developed systematized application technique (Dose, Apply, Spread) were compared. Evaluation criteria included the amount of product applied, the homogeneity of sunscreen application as measured by the Wood's lamp, and the volunteers' appreciation of the new technique. RESULTS: Fifty-eight volunteers participated in the study: 20 women, 19 men, and 19 children. Respecting the new application technique resulted in a statistically significant (P < 0.05) more evenly spread sunscreen on the different parts of the body and an increase in the amount of product applied. Furthermore, the body surface area covered was significantly increased (P < 0.05), and the new technique was well perceived and accepted by the volunteers. CONCLUSION: The proposed new application technique ensures that more sunscreen will be used and that it will be applied more evenly. Educational work could help improve the efficient use of sunscreens, therefore providing better UV protection.

A skincare containing retinol adenosine and hyaluronic acid optimises the benefits from a type A botulinum toxin injection.

INTRODUCTION: A monocentre double-blind two parallel group clinical study was conducted to assess whether a new skincare regimen containing retinol, adenosine and hyaluronic acid, applied after the injection of botulinum toxin A to the glabellar area, provided a beneficial effect. MATERIAL AND METHODS: Standardised photographs acquired using LifeViz cameras and zoomed pictures of the glabella and of the crow's feet areas were analysed with automatic well-defined procedures. Perceived efficacy and tolerance were also analysed by comparison between the two groups. RESULTS: A beneficial effect versus placebo-treated group was proven in the group having topically applied the new skincare regimen for 2 months following botulinum toxin A injection with no touch up after 1 month. 3D image analysis showed more rapid results on D10 and enhanced efficacy on M2. Moreover, a beneficial effect independent of injection was measured in the crow's feet area, and analysis of the self-evaluation questionnaire showed enhanced efficacy perceived by the volunteers. CONCLUSION: A specially developed skincare regimen applied immediately after botulinum toxin A injection completes the beneficial effect of the injection on the glabellar area and offers clinical benefits in fine lines, wrinkles and smoothness on the whole face.

Topical effectiveness of a cosmetic skincare treatment for acne-prone skin: a clinical study.

BACKGROUND: Physiological acne is a milder form of clinical acne and is very frequent in adult women (18 years of age and older). Acne therapy is usually unnecessary in such cases, and so appropriate cosmetic treatments are sought. OBJECTIVES: To determine the effectiveness of a topical cosmetic hydrating skincare treatment for adult acne-prone skin (Normaderm, Vichy, France) against the clinical signs of physiological acne: few inflammatory and retentional lesions, uneven (grainy) skin relief, dilated pores, and occasional and/or local hyperseborrhea. METHODS: Within the study, the tested product's keratolytic, antimicrobial, and antiseborrheic properties, and its overall ability to improve the clinical signs of physiological acne present in adult subjects were evaluated through objective and clinical evaluation methods by the investigators and through self-evaluation questionnaires by the subjects themselves. The study group was composed of 50 adult women between 18 and 35 years of age with combination or oily acne-prone skin, who were chosen according to previously defined inclusion criteria. They applied the product tested twice daily on thoroughly cleansed skin for a period of 2 months. The results were evaluated after 30 (±2) and 60 (±2) days. RESULTS: The number of inflammatory and retentional lesions on the forehead, cheeks, and chin decreased after 60 days of use (an average of 30.7% and 70.7%, respectively). The level of sebum secretion on the forehead decreased by 33.4% and the level of skin scaling decreased by 38.5% after 60 days of use. The moisture content in the horny layer on the forehead, cheeks, and chin increased by an average 39.7%. The decrease in pore size and content after 60 days of use was very noticeable. The subjects evaluated all the studied characteristics of the product tested very positively, with results already showing after 30 days of use. CONCLUSIONS: The results of the study confirm that the product tested is suitable for the cosmetic care of adult acne-prone skin, either as an independent cosmetic hydrating skincare treatment, as a complementary cosmetic part of acne therapy, or as a subsequent cosmetic regimen to sustain the results of the acne therapy for a longer period of time.

Correlates of health-related quality of life in women with severe facial blemishes.

BACKGROUND: Facial appearance plays a large role in self-perception and interaction with others. Visible facial skin lesions are a common condition. Purpose This study assessed factors associated with health-related quality of life (HRQOL) in women with visible facial skin lesions. METHODS: The study included 73 women with one or more of the following conditions: acne, dermatosis papulosis, hypopigmentation, lentigenes, melasma, rosacea, vascular proliferations and other facial scars. The Skindex-16 was used as a measure of HRQOL. Fear of negative evaluation (FNE) was assessed to determine whether self-perception characteristics relate to HRQOL. RESULTS: There were strong correlations in both bivariate and multivariate analyses among increased FNE, heightened perception of QOL without the facial condition and lower overall HRQOL (P< 0.05 and P< 0.01, respectively). There were no differences in HRQOL by type of facial condition, as well as no effects of the area covered by the condition on HRQOL. Interestingly, women not using foundations represented only 10% of the study population and had better HRQOL than women who did use foundations. CONCLUSIONS: Severe facial blemishes of any cause have a significant impact on women's QOL, and the effect of these lesions is mediated in part by psychological characteristics related to self-perception and self-presentation.

Corrective cosmetics are effective for women with facial pigmentary disorders.

Visible facial lesions are a common and burdensome skin problem. This study examines the impact of corrective cosmetics in women with severe facial pigmentary disorders. Enrollment consisted of 73 women with one or more of the following conditions: acne, dermatosis papulosis, hypopigmentation, lentigines, melasma, rosacea, vascular proliferations, or other facial scars. The corrective cosmetic (Dermablend) was applied at the initial visit, at which time instructions and a supply of product were provided. Assessments were conducted at baseline, 2-week, 4-week, and 3-month follow-up visits on 63 patients using the Skindex-16. The corrective cosmetic was well tolerated. There was improvement in Skindex-16 scores after application of the corrective cosmetic, which continued at each follow-up visit and after adjustment for baseline confounders using multiple regression analyses. At 3 months, there was a 30% improvement in Skindex-16 score (P < .001). The corrective cosmetic was well tolerated and represents a valuable option that dermatologists can offer to patients with these conditions.