Efficacy and safety of Politranexamide® liposomal emulsion on facial melasma: A comparative study.

INTRODUCTION: Melasma is a human melanogenesis dysfunction that results in localized, chronic acquired hypermelanosis of the skin difficult to treat. METHODS: This prospective, randomized, single-blind, study aimed to compare the efficacy and tolerability of a liposomal emulsion based on Politranexamide® (SAMPLE A) with that of a competitor based on acetylglucosamine, ethyl linoleate and phenyl ethyl resorcinol (SAMPLE B) in patients affected by facial melasma on 26 patients. Disease severity was assessed by the Melasma Area Severity Index (MASI) at baseline and after 6 and 12 weeks of therapy. All patients were subjected to photo documentation using DermaView camera and Antera 3D camera. RESULTS: The mean MASI score at baseline was 10.93 ± 7 in the group A and 9.34 ± 6.29 in the group B, respectively. A significant decrease in MASI score from baseline was noted in both treatment groups as early as 6 weeks of follow-up (p = 0.00096 for SAMPLE A and p = 0.0049 for SAMPLE B) and was confirmed at the end of the treatment (p = 0.0006 for SAMPLE A and p = 0.00039 for SAMPLE B). Intergroup comparison revealed a greater improvement of melasma among patients in group A compared to those in group B that was quite statistically significant at weeks 6 (p = 0.055009) and significant after 12 weeks of follow-up (p = 0.032942). Both treatment groups experienced an improvement in Antera average level of melanin. CONCLUSION: Our results suggested Politranexamide® to be a useful and safe therapeutic option in treating melasma, more effective than competitor used in this study.

Pleiotropic effect of Lactoferrin in the prevention and treatment of COVID-19 infection: in vivo, in silico and in vitro preliminary evidences

Lactoferrin, a multifunctional cationic glycoprotein, secreted by exocrine glands and neutrophils, possesses an antiviral activity extendable to SARS-CoV-2. We performed in vitro assays proving lactoferrin antiviral activity through direct attachment to both virus and cell surface components. This activity varied according to concentration (100/500g/ml), multiplicity of infection (0.1/0.01) and cell type (Vero E6/Caco-2 cells). Interestingly, the in silico results strongly supported the hypothesis of a direct recognition between the lactoferrin and the Spike S glycoprotein, thus hindering the viral entry into the cells. Hence, we conducted a clinical trial to investigate effect and tolerability of a liposomal lactoferrin formulation as a supplementary nutraceutical agent in mild-to-moderate and asymptomatic COVID-19 patients. A total of 92 mild-to-moderate (67/92) and asymptomatic (25/92) COVID-19 patients were recruited and divided in 3 groups according to the administered regimen. Thirty-two patients, 14 hospitalised and 18 in home-based insolation received oral and intranasal liposomal bovine lactoferrin (bLf), 32 hospitalised patients were treated with standard of care treatment (hydroxychloroquine, azitromicin and lopinavir/darunavir), and 28, in home-based isolation, did not take any medication. Furthermore, 32 COVID-19 negative, not-treated, healthy subjects were added as a control group for ancillary analysis. bLf-supplemented COVID-19 patients obtained an earlier and significant (p < 0,0001.) median rRT-PCR SARS-COV-2 RNA negative conversion than standard of care-treated and non-treated COVID-19 patients (14.25 vs 27.13 vs 32.61 days, respectively). In addition, bLf-supplemented COVID-19 patients showed significant fast clinical symptoms recovery than standard of care-treated and non-treated COVID-19 patients. Moreover, in bLf-supplemented patients, a significant decrease of either serum ferritin or IL-6 levels or host iron overload, all parameters characterizing inflammatory processes, were observed. Serum D-dimers was also found significantly decreased following bLf supplement. No adverse events were reported. These in vitro and in vivo observations led us to speculate a potential and safe supplementary role of Blf in the management of mild-to-moderate and asymptomatic COVID-19 patients.

A new TaqMan method for the identification of phytoplasmas associated with grapevine yellows by real-time PCR assay.

Three real-time PCR systems for direct detection of phytoplasmas associated to Flavescence dorée (FD), Bois noir (BN) and aster yellows (AY) diseases were developed. TaqMan probes and primers were designed on the 16S ribosomal RNA sequences of phytoplasma genome. A further TaqMan assay, targeting a grapevine gene encoding for the chloroplast chaperonin 21, was developed in order to check the DNA quality and to verify the absence of PCR inhibition. A comparison between real-time PCR and conventional nested-PCR methods for phytoplasma detection was carried out on several reference samples from grapevine, periwinkle, other host plants and insect species. Detection of FD, BN and AY phytoplasma DNA on infected specimens was rapid, specific and reproducible. Sensitivity was as high as nested-PCR assay. The two procedures were then used on about 450 samples collected from grapevines showing yellows symptoms. The results showed that real-time PCR approach for phytodiagnostic purposes was more advantageous than nested-PCR method with regard to rapidity of the assay and reduced risk of sample cross contamination. These new protocols represent an improvement of existing analytical methods and could be used as a reliable diagnostic procedure in certification and control programs.