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.

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.

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.

Ferrous sulfate oral solution in young children with iron deficiency anemia: An open-label trial of efficacy, safety, and acceptability.

BACKGROUND: This study evaluated the efficacy, safety, and acceptability of a new ferrous sulfate oral solution (Tardyferon® 20 mg/mL) in young children with mild or moderate iron deficiency anemia (IDA). METHODS: This was a multicenter, national, single-arm, open-label study. Children aged 6-53 months presenting with mild or moderate IDA (i.e., blood hemoglobin (Hb) ranging from 7.0 to 10.9 g/dL and serum ferritin <12 ng/mL) were eligible for inclusion. The ferrous sulfate heptahydrate solution (2 mg/kg/day) was administered orally for 3 months. If normalization of either Hb or ferritin was not achieved at month 3 the treatment was continued for another 3 months. RESULTS: Of the 100 children screened, 21 aged 6-17 months were included and received the study treatment, and 19 were analyzed for hematologic outcomes at month 3. Only one patient continued treatment for the additional 3 months. At month 3, mean ± SD Hb and ferritin levels were 12.0 ± 0.7 g/dL and 31.5 ± 19.4 ng/mL, respectively. Hemoglobin and ferritin levels were normalized in 95% (18/19) and 84% (16/19) of the patients, respectively. Treatment compliance and levels of satisfaction of both the parents and the investigators were high. Overall, 33.3% of patients (7/21) experienced at least one adverse event. Only one patient (4.8%) experienced a drug-related adverse event (upper abdominal pain). CONCLUSIONS: A 2 mg/kg daily dose of the new oral ferrous sulfate heptahydrate solution provides substantial therapeutic benefit with high levels of tolerability in young children who have mild or moderate IDA.

Melanoma chemotherapy leads to the selection of ABCB5-expressing cells.

Metastatic melanoma is the most aggressive skin cancer. Recently, phenotypically distinct subpopulations of tumor cells were identified. Among them, ABCB5-expressing cells were proposed to display an enhanced tumorigenicity with stem cell-like properties. In addition, ABCB5(+) cells are thought to participate to chemoresistance through a potential efflux function of ABCB5. Nevertheless, the fate of these cells upon drugs that are used in melanoma chemotherapy remains to be clarified. Here we explored the effect of anti-melanoma treatments on the ABCB5-expressing cells. Using a melanoma xenograft model (WM266-4), we observed in vivo that ABCB5-expressing cells are enriched after a temozolomide treatment that induces a significant tumor regression. These results were further confirmed in a preliminary study conducted on clinical samples from patients that received dacarbazine. In vitro, we showed that ABCB5-expressing cells selectively survive when exposed to dacarbazine, the reference treatment of metastatic melanoma, but also to vemurafenib, a new inhibitor of the mutated kinase V600E BRAF and other various chemotherapeutic drugs. Our results show that anti-melanoma chemotherapy might participate to the chemoresistance acquisition by selecting tumor cell subpopulations expressing ABCB5. This is of particular importance in understanding the relapses observed after anti-melanoma treatments and reinforces the interest of ABCB5 and ABCB5-expressing cells as potential therapeutic targets in melanoma.

Human adipocyte fatty acid-binding protein (aP2) gene promoter-driven reporter assay discriminates nonlipogenic peroxisome proliferator-activated receptor gamma ligands.

Peroxisome proliferator-activated receptors (PPARs) regulate storage and catabolism of fats and carbohydrates. PPARgamma activity increases insulin sensitivity and adipocyte differentiation at the expense of adipogenesis and weight gain. The goal of this study was to 1) clone the promoter of the human adipocyte fatty acid binding protein (aP2) gene, namely fatty acid-binding protein-4, 2) characterize its pharmacological regulation, and 3) determine its putative predictability for adipogenesis. Among the selected PPAR agonists, rosiglitazone and pioglitazone displayed the highest maximal efficacy (E(max)) on reporter-gene assays in COS-7 cells cotransfected by either a galactosidase 4-response element-based or a human aP2 promoter-based Luc reporter vector, along with either chimeric or full-length human PPAR expression plasmids. The non-subtype-selective 2-(4-[2-(3-[2,4-difluorophenyl]-1-heptylureido)ethyl]phenoxy)-2-methyl-butyric acid (GW-2331) and the compounds [4-[3-(4-acetyl-3-hydroxy-2-propylphenoxy)-propoxyl]phenoxy]-acetic acid (L-165041), (4-((2S,5S)-5-(2-(bis(phenylmethyl)amino)-2-oxoethyl)-2-heptyl-4-oxo-3-thiazolidinyl)butyl)-benzoic acid (GW-0072), and indomethacin behaved as partial agonists relative to pioglitazone in full-length human aP2-PPARgamma2. Beyond their partial PPARgamma agonist properties, these compounds elicited a lower maximal up-regulation of mouse aP2 mRNA in 3T3-L1 adipocytes as compared with pioglitazone; these properties paralleled a time-dependent increase in neutral lipids. By contrast, the selective PPARalpha agonist 2,2-dichloro-12-(4-chlorophenyl)dodecanoic acid (BM-17.0744) neither stimulated the human aP2-PPARalpha promoter reporter-gene assay, thus demonstrating a specific interaction between PPARgamma and the aP2 promoter, nor affected lipogenesis in 3T3-L1 cells. Altogether, these data characterized a functional promoter of the human aP2 gene; its in vitro pharmacological regulation in PPARgamma-mediated reporter-gene assay may represent an interesting complement or an alternative to time-consuming procedures aiming at discriminating PPAR ligands with low lipogenic properties.