Real-world effectiveness and tolerability of a cream containing postbiotic Aquaphilus dolomiae extract-G3 in subjects with sensitive facial skin.

Previous studies indicate that a postbiotic extract from Aquaphilus dolomiae (ADE-G3) improves skin barrier function and relieves neuroinflammation. Evaluation of an ADE-G3-based soothing cream for managing sensitive facial skin. This real-world, international, pre-post comparative study involved adults with sensitive facial skin who used the study product once or twice daily for two to three months according to usual practice. Subjects reported changes in perceived clinical symptoms using self-administered questionnaires. Physicians assessed changes in xerosis severity, overall product effectiveness and tolerability. User satisfaction and quality of life (QoL) assessments, and subgroup analyses according to the factors triggering sensitive skin were also conducted. In total, 2,382 subjects with sensitive facial skin (female: 79%; median age: 40 years) were included. An immediate skin soothing effect after the first ADE-G3-based cream application was reported by 93% of subjects, and improvements in symptoms were reported in 94% after a mean of nine days of product use. After several months of use (mean: 71±21 days), xerosis severity and dermatological-related QoL significantly improved in the whole study population and in the subgroups (p<0.001). At the end of the study, 92% of users were satisfied with the product and 95% reported improvements in their overall skin condition. Physicians found the cream to be effective and well tolerated in 92% and 98% of subjects, respectively. Regular use of the ADE-G3-based cream was shown to be effective in real-world management of sensitive facial skin, regardless of the factors involved in triggering skin sensitivity.

The Real-World Effectiveness and Tolerability of a Soothing Cream Containing the Postbiotic Aquaphilus dolomiae Extract-G2 for Skin Healing.

INTRODUCTION: In vitro and pre-marketing clinical data have shown the healing properties of a postbiotic extract from Aquaphilus dolomiae (ADE-G2). The effectiveness and tolerability of an ADE-G2-based cream were therefore evaluated for the management of minor skin impairment and wound healing in a large population of subjects in routine clinical practice. METHODS: A real-world, international, pre-post comparative study was conducted in infants, children, and adults with various types of superficial skin impairment who used the study product daily for around 3 weeks according to their dermatologist's advice. Immediate and follow-up changes in dermatologic signs and symptoms were assessed through clinical scoring. User satisfaction, overall product effectiveness, and tolerability were also evaluated. Analyses were performed in the whole study population and in subject subgroups according to skin impairment type and age. RESULTS: Overall, 1317 subjects (83.1% adults, 72.0% female) were included. Dermatologists reported effectiveness and "good" or "very good" tolerability of the cream in 93.8% (1221/1302) and 98.5% (1278/1297) of subjects, respectively. Immediate symptom relief after the first application was reported by 88.3% (849/962) of subjects. After several weeks of regular use (16.7 ± 11.6 days), dermatologic signs and symptoms significantly improved in the whole study population and in the subgroups, with mean decreases in severity scores ranging from -34.5% to -92.5% (p < 0.0001). The smallest improvements were found in subjects with oncologic treatment-related skin impairment. At study end, most users (> 95%) were "very satisfied" or "satisfied" with the cream and found that skin healing was rapid and of good quality. CONCLUSION: The ADE-G2-based cream proved to be effective and well tolerated in real-life conditions for the management of minor skin impairment in a large and varied cohort of subjects. This product, used as a standalone or adjunctive regimen, can help accelerate the healing of various types of superficial skin impairment.

Efficacy of Avène Hydrotherapy on Chronic Pruritus in Patients with Plaque Psoriasis.

INTRODUCTION: Pruritus is a prevalent symptom, described as one of the most bothersome of psoriasis. Specific itch management remains a challenge, for which hydrotherapy could be used as adjunct care to medical treatment. Therefore, we assessed the immediate and longer-term benefit of 3 weeks of Avène thermal spring water hydrotherapy on chronic pruritus in patients in addition to their usual psoriasis and/or pruritus management. METHODS: Twenty-six patients suffering from chronic pruritus due to psoriasis were evaluated before and after 3 weeks of hydrotherapy with a 3 and 6 month follow-up. A control group (18 patients) did not undergo hydrotherapy and continued to follow their usual skin management. Pruritus was assessed according to the numeric rating scale (NRS, pruritus intensity), the visual dynamic pruritus score (vDPS, change in pruritus intensity), and the 5-D itch scale (pruritus characteristics). Psoriasis severity was measured using the psoriasis area and severity index (PASI) score. The "itchy quality of life" (ItchQoL) scale was used to assess quality-of-life (QoL) impact related to itch. Pruritus and psoriasis gene and protein biomarkers were measured in lesional and nonlesional skin. RESULTS: Pruritus measurements (NRS, vDPS, and 5-D itch scale) indicated an immediate and long-lasting positive effect of hydrotherapy compared with control patients. The psoriasis area and severity index (PASI) was decreased by 40.0% by hydrotherapy, which was sustained over 6 months. The ItchQoL also improved directly after hydrotherapy, which was still much improved even 6 months later. Analysis of gene and/or protein biomarkers revealed a significant decrease of inflammation biomarkers (IL-8, IL-1α, IL-1RA, and RANTES), of psoriasis biomarkers (PI3, S100A7, and IL-17), and of pruritus biomarkers (IL-31, TRPV1, and CGRP1). CONCLUSIONS: These findings demonstrated an immediate and long-lasting improvement of pruritus in patients with psoriasis who underwent Avène thermal spring water hydrotherapy, indicating that this would be a good complementary therapy in the management of this disease. TRIAL REGISTRATION: NCT03023254.

Tolerability and effectiveness of a dermocosmetic product containing Silybum marianum fruit extract in adolescents and young adults with acne-prone skin: An international, phase IV, longitudinal study.

BACKGROUND: Dermocosmetic products are often used to maintain or enhance the tolerance and effectiveness of medical anti-acne therapies. Recent discoveries about the pathophysiology of acne-prone skin indicate that skincare products may help maintain homeostasis around the sebaceous gland progenitor cells, thereby preventing microcomedone formation. AIMS: To evaluate the tolerance and effectiveness of a dermocosmetic product containing Silybum marianum fruit extract (SMFE) in adolescents and young adults with acne-prone skin. PATIENTS/METHODS: This real-life, international, observational, multicenter study was conducted in patients aged 12-25 years with mild-to-moderate acne. Patients (N = 4230) used the product twice daily for 8-12 weeks, either alone before ("initial group") or after an anti-acne therapy ("maintenance group"), or in association with their usual prescribed anti-acne therapies ("association group"). The tolerance, effectiveness, and cosmetic properties of the product were assessed. Patient quality of life (QoL) was also evaluated. RESULTS: Dermatologists rated the tolerance of the product as "good" or "very good" in about 95% of the patients and the effectiveness of the product as "effective" or "highly effective" in about 80% of the patients, with a significant reduction in the mean global evaluation of acne (GEA) grade (-36% ± 39%, p < 0.0001) at study end. The QoL of most patients (80%) improved by the end of the study, and the majority (79% to 94%) appreciated the cosmetic properties of the product. Overall, the product was a clinical success in >84% of patients. CONCLUSIONS: This dermocosmetic product can be used by adolescents and young adults with acne-prone skin to limit the initial or chronic use of medical anti-acne therapies.

Clinical studies in Chinese subjects investigating the tolerance and soothing efficacy of a cream and balm containing 4-t-butylcyclohexanol on the sensitivity of facial skin.

INTRODUCTION: Asian subjects are particularly prone to skin sensitivity. We developed a facial cream and balm containing 4-t-butylcyclohexanol to provide skin comfort and a soothing effect for sensitive skin. OBJECTIVES: Assess the dermatological and ophthalmological tolerance and efficacy in improving skin sensitivity of face cream and balm under normal conditions of use by a population known to be particularly prone to this problem. METHODS: In a monocentric non-randomized open trial, the cream or balm was applied twice daily to the face, neck, and eye contour of 33 stinger subjects with hypersensitive skin (22-63 years old). Assessments included dermatological and ophthalmological physical and functional signs on Day 1 (D1), D8, and D22, and cosmetic acceptability, cutaneous sensitivity according to a stinging test and the sensitive scale, and the soothing efficacy according to a questionnaire on D22. RESULTS: The cream and balm were very well tolerated. Immediately after application, subjects reported a reduction in the skin's hypersensitivity (93.9% of subjects for the cream and 81.8% for the balm), skin redness (90.9% of subjects for the cream and 87.9% for the balm), sensations of tightness (93.9% for the cream and 97.0% for the balm), and discomfort sensations (93.9% for the cream and 87.9% for the balm). After 21 days, the application of the cream and balm decreased the stinging scores by 65% and 41%, respectively, with 94% and 77% of subjects showing an improvement, respectively. The sensitivity scale questionnaire indicated that the cream and balm significantly and profoundly decreased all negative signs, for example, irritability, stinging, general discomfort, redness, and dryness on D22 compared to D1. On D22, all 15 parameters recorded were improved by 89%-100% by the cream and by 74%-100% by the balm. The majority (90.9% and 96.8% of subjects using the cream and balm, respectively) of the subjects noticed positive changes in their skin condition after using the product for 21 days. CONCLUSIONS: The cream and balm were very well-tolerated. This study demonstrated that both products controlled and markedly reduced skin hypersensitivity in Asian subjects, with an immediate and lasting skin soothing and repairing effect over 21 days.

INTRODUCTION: Les sujets asiatiques ont particulièrement tendance à avoir une peau sensible. Nous avons développé une crème et un baume pour le visage, contenant du 4-t-butylcyclohexanol, pour apporter confort cutané et effet apaisant aux peaux sensibles. OBJECTIFS: Evaluer la tolérance dermatologique et ophtalmologique ainsi que l'efficacité d'une crème et d'un baume pour le visage dans l'amélioration de la sensibilité cutanée, en conditions normales d'utilisation par une population connue pour être particulièrement sujette à ce problème. MÉTHODES: Dans une étude monocentrique, non randomisée et ouverte, la crème et le baume ont été appliqués deux fois par jour sur le visage, le cou et le contour des yeux de 33 sujets stingers présentant une peau hypersensible (de 22 à 63 ans). Les évaluations incluaient une analyse des signes dermatologiques et ophtalmologiques physiques et fonctionnels le Jour 1 (J1), J8, et J22 ; l'acceptabilité cosmétique, la sensibilité cutanée selon un stinging test et l'échelle de sensibilité, et l'effet apaisant selon un questionnaire à J22. RÉSULTATS: La crème et le baume ont été très bien tolérés. Immédiatement après application, les sujets ont rapporté une réduction de l'hypersensibilité cutanée (93.9% de sujets pour la crème, 81.8% pour le baume), des rougeurs de la peau (90.9% de sujets pour la crème, 87.9% pour le baume), des sensations de tiraillement (93.9% de sujets pour la crème, 97.0% pour le baume), et des sensations d'inconfort (93.9% de sujets pour la crème, 87.9% pour le baume). Après 21 jours, l'application de la crème et ou du baume a permis de diminuer les stinging scores respectivement de 65% et 41%, avec 94% et 77% de sujets présentant une amélioration. Le questionnaire de l'échelle de sensibilité a démontré que la crème et le baume ont significativement et fortement réduit tous les signes négatifs comme l'irritabilité, les picotements, l'inconfort général, les rougeurs et la sécheresse à J22 comparé à J1. A J22, l'ensemble des 15 paramètres suivis ont été améliorés de 89-100% par la crème et de 74-100% par le baume. Après usage du produit pendant 21 jours, la majorité des sujets (90.9% et 96.8% des sujets utilisant respectivement la crème ou le baume) a remarqué des changements positifs sur l'état de leur peau. CONCLUSIONS: La crème et le baume ont été très bien tolérés. Cette étude a démontré que ces deux produits contrôlaient et réduisaient nettement l'hypersensibilité de la peau de sujets asiatiques, avec un effet apaisant et réparateur immédiat et durable sur la peau durant 21 jours.

An Emollient PLUS Balm Is Useful for the Management of Xerosis in Patients Treated for Cancer: A Real-World, Prospective, Observational, Multicenter Study.

INTRODUCTION: Xerosis is a common skin side effect of current anticancer therapies, including chemotherapy, targeted therapy, radiotherapy, and hormonotherapy. We evaluated the effectiveness of an emollient PLUS containing an Aquaphilus dolomiae extract (ADE-G1) for the management of xerosis in adult patients treated for cancer. METHODS: This real-world, prospective, observational, multicenter study involved 319 xerotic cancer patients, who were prescribed the study product according to the usual practice of their physician. The practitioner assessed xerosis severity and objective clinical signs, and the patients assessed subjective clinical signs and the impact of their skin condition on their quality of life, at inclusion and after around 4 weeks of use. Overall effectiveness and tolerance were assessed at the end of the study. Clinical success was defined by the combination of several of these effectiveness outcomes. RESULTS: Daily application of the emollient PLUS reduced xerosis severity in 62.7% of patients (p < 0.0001). The mean total severity scores for objective and subjective clinical signs were reduced by 67.7% and 57.4% (p < 0.0001), respectively, compared with baseline. The mean Dermatology Life Quality Index (DLQI) score also significantly improved at the end of follow-up (-56.6%, p < 0.0001). The product was rated as "effective" or "very effective" by the physician for over 80% of patients, regardless of the initial severity grade of xerosis. Overall clinical success was achieved in 73.7% of patients. A trend toward higher effectiveness and clinical success was observed in patients under hormonotherapy. The study product was well tolerated, regardless of the anticancer therapy being received. CONCLUSION: This study shows that the emollient PLUS containing ADE-G1 is an effective treatment for xerosis in cancer patients, regardless of the initial grade of xerosis and the anticancer treatment received.

Long-Term Use of Silybum marianum fruit extract Contributes to Homeostasis in Acne-Prone Skin-A 12-Month Follow-Up International "Real Life" Cohort Study.

BACKGROUND: Homeostasis in the differentiation programme of sebaceous stem cells has been identified as a key step in comedogenesis and should be a target for acne-prone skin care. OBJECTIVE: To report on a multicentre, year-long/real-life use study of a patented natural product containing S. marianum fruit extract proven to modulate molecular actors in the initial steps of comedogenesis. METHODS: An open-label multicentric international study, with a 12 month follow-up, included 54 teenage and young adult subjects with mild to moderate facial acne. The study was aimed at reproducing a real-life use context. RESULTS: Total lesion count mean was 88.3 at inclusion. There was a sustained, highly significant decrease over the months of clinical lesion counts (45.6% improvement after 6 months and 59.6% at 12 months) and on other efficacy markers, associated with a significant decrease in global microcomedone quantity on cyanoacrylate superficial skin surface biopsies. Importantly, the study protocol allowed the dermatologist to prescribe, if needed as in real life, any of the acne drugs registered in the acne guidelines. The exposure to these acne drugs during the whole year was calculated as a percentage of S. marianum fruit extract/352 days of use and happened to be very limited at less than 4%, which indicates a marginal contribution to the sustained clinical improvement. (Oral and local acne treatments: Lymecycline 1.46%; Doxycycline 0.24%; Adapalene 0.16% or gel association with Benzoyl peroxide 1.17%; Clindamycin 0.04%; Benzoyl peroxide 1.5%; Erythromycin 0.75%). The tolerance with daily S. marianum fruit extract long-term use was good. LIMITATIONS: The association with routine prescription acne drugs when needed, even if limited, does not allow a full evaluation of the intrinsic quantitative efficacy of S. marianum fruit extract in lesion reduction. CONCLUSION: This open, real-life, year-long multicentre study confirms a previous 48-week proof of concept study and qualifies the use of S. marianum fruit extract as a "field-dermo cosmetic" contributing to homeostasis of acne-prone skin in association with acne drugs.

Immune checkpoint-mediated psoriasis: A multicenter European study of 115 patients from the European Network for Cutaneous Adverse Event to Oncologic Drugs (ENCADO) group.

BACKGROUND: Immune checkpoint inhibitor (ICI)-mediated psoriasis poses significant diagnostic and therapeutic challenges. OBJECTIVE: To report data on ICI-mediated psoriasis, emerging from the largest cohort to date, to our knowledge, and to propose a step-by-step management algorithm. METHODS: The medical records of all patients with ICI-mediated psoriasis were retrospectively reviewed across 9 institutions. RESULTS: We included a cohort of 115 individuals. Grade 1, 2, and 3 disease severity was reported in 60 of 105 (57.1%, 10 missing data), 34 of 105 (32.4%), and 11 of 105 (10.5%), respectively. The ratio between exacerbation and de novo cases was 1:4.3. The most common systemic therapy was acitretin (23 patients, 20.1%), followed by systemic steroids (8 patients, 7%), apremilast (7 patients, 6.1%), methotrexate (5 patients, 4.3%) and biologics (4 patients, 3.6%). Overall, 29 of 112 patients (25.9%) interrupted and 20 of 111 (18%) permanently discontinued ICIs because of psoriasis. Body surface area of greater than 10% at baseline had a 3.6 increased risk for ICI treatment modification (odds ratio, 3.64; 95% confidence interval, 1.27-10.45; P = .03) and a 6.4 increased risk for permanent discontinuation (odds ratio, 6.41; 95% confidence interval, 2.40-17.11; P < .001). Guttate psoriasis and grade 2 or 3 disease were significant positive predictors for antitumor response of ICI, whereas pruritus was a negative predictor. LIMITATIONS: Retrospective design. CONCLUSION: Acitretin, apremilast, and methotrexate are safe and effective modalities for ICI-mediated psoriasis. In most cases, ICI can be completed unhindered. A therapeutic algorithm is proposed.

Association of APOA5 and APOC3 Genetic Polymorphisms With Severity of Hypertriglyceridemia in Patients With Cutaneous T-Cell Lymphoma Treated With Bexarotene.

Importance: Hypertriglyceridemia is the most frequent and limiting adverse effect of bexarotene therapy in cutaneous T-cell lymphoma (CTCL). Despite standard prophylactic measures, there is a wide variability in the severity of this complication, which could be associated with both genetic and environmental factors. Objectives: To analyze the association between genetic polymorphisms of apolipoprotein genes APOA5, APOC3, and APOE and the severity of hypertriglyceridemia during bexarotene therapy and to optimize patient selection for bexarotene therapy based on adverse effect profile. Design, Setting, and Participants: This case series study was conducted in 12 university referral hospitals in Spain from September 17, 2014, to February 6, 2015. One hundred twenty-five patients with a confirmed diagnosis of CTCL who had received bexarotene therapy for at least 3 months were enrolled. Nine patients were excluded owing to missing analytic triglyceride level data, leaving a study group of 116 patients. Data on demographic and cardiovascular risk factor were collected, and a complete blood analysis, including lipid profile and genetic analysis from a saliva sample, was performed. Main Outcomes and Measures: Primary outcomes were the maximal triglyceride levels reported in association with the minor alleles of the polymorphisms studied. Results: Among 116 patients, the mean (SD) age was 61.2 (14.7) years, 69 (59.5%) were men, and 85 (73.2%) had mycosis fungoides, the most prevalent form of CTCL. During bexarotene therapy, 96 patients (82.7%) experienced hypertriglyceridemia, which was severe or extreme in 8 of these patients (8.3%). Patients who carried minor alleles of the polymorphisms did not show significant differences in baseline triglyceride concentrations. After bexarotene treatment, carriers of at least 1 of the 2 minor alleles of APOA5 c.-1131T>C and APOC3 c.*40C>G showed lower levels of triglycerides than noncarriers (mean [SD], 241.59 [169.91] vs 330.97 [169.03] mg/dL, respectively; P = .02). Conclusions and Relevance: These results indicate that the screening of APOA5 and APOC3 genotypes may be useful to estimate changes in triglyceride concentrations during bexarotene treatment in patients with CTCL and also to identify the best candidates for bexarotene therapy based on the expected adverse effect profile.

Local cryosurgery and imiquimod: A successful combination for the treatment of locoregional cutaneous metastasis of melanoma: A case series.

Locoregional cutaneous metastases of melanoma (LCMM) represent a therapeutic challenge. Many treatment options are available with varying results. The combination of cryotherapy and imiquimod, two treatments with a possible synergistic effect, has not yet been described for treating this disease. In this paper, we aimed to show the response of LCMM to cryotherapy combined with topical imiquimod 5%. A retrospective review of 20 patients diagnosed with LCMM and treated with cryotherapy combined with topical imiquimod 5% between November 2000 and May 2014 at three institutions was performed. The locoregional cutaneous response was evaluated. After a mean of five sessions, 13 patients (65%) responded to treatment, eight (40%) of these completely and five (25%) partially. Systemic disease progressed in 16 (80%) patients. Cryotherapy followed by topical imiquimod 5% is simple to apply, has minimal adverse effects and provides response rates similar to other, more complex treatment options.