Proportion of Subjects Achieving a Molluscum Lesion Count of 0 or 1 at the Day 84 End of Study Visit in Phase 3 Clinical Trials with VP-102 CAMP-1 and CAMP-2

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SURG-04. Surgical resection of symptomatic brain metastasis in patients with non-small cell lung cancer irrespective from lesion count

Background and Purpose Current guidelines primarily suggest the resection in case of a limited number of brain metastases (BM). With an increasing number of local and systemic treatment options this approach needs reconsideration. Therefore, we aimed to evaluate the role of metastectomy in patients with non-small cell lung cancer (NSCLC) treated in a comprehensive setting disregarding lesion count. Patients and Methods In this monocentric retrospective analysis, patients receiving surgery for 1–3 BM with available demographic, clinical, and tumor-associated parameters were included. Prognostic factors for local control (LC) and overall survival (OS) were analyzed by Log rank test and Cox proportional hazards. Results Two-hundred-sixteen patients were included: 129 (59.7%) with single/solitary, 64 (29.6%) with 2–3, and 23 (10.6%) with more than three BM. Resection of the symptomatic BM(s) improved the patients’ Karnofsky performance index (KPI) significantly (p<0.001), enabling adjuvant radiotherapy in 199 (92.1%) and systemic treatment in 119 (55.1%) patients. After a mean radiological follow-up of eight (1–79) months, LC was observed in 83 (38.4%) patients and was not significantly influenced by BM count (p=0.064). After a mean OS after surgery of 12.7 (0–88) months, 120 (55.6%) patients had died. In univariate analysis, BM count showed no impact on OS (p=0.844), while age ≥/< 65 years (p=0.007), pre- and postoperative KPI ≥70 (p=0.002 and p=0.005, respectively), extra-cranial metastases (p=0.004), adjuvant radiation therapy (p<0.001), and adjuvant systemic treatment (p<0.001) did. In regression analysis the presence of extra-cranial metastases (HR 2.30 95%CI 1.53–3.48; p<0.001), adjuvant radiation therapy (HR 0.97 95%CI 0.23–0.86; p=0.016), and adjuvant systemic treatment (HR 0.37 95%CI 0.25–0.55; p<0.001) remained independent factors for survival. Conclusions The indication for resection of symptomatic BM in patients with NSCLC is justified even in case of multiple lesions to alleviate their neurological symptoms and to enable further treatment.

Retinal oxygen saturation changes progressively over time in diabetic retinopathy

Purpose According to cross-sectional studies, oxygen saturation is elevated in retinal vessels in diabetic patients. We evaluated how retinal oxygenation (metabolic marker), vessel diameters and retinopathy grade (structural markers) change over time in diabetic patients. Design Prospective cohort study following screening in a hospital setting. Methods Retinal oximetry images were acquired in 214 patients with the Oxymap T1 oximeter. Imaging was repeated after a median of 3.0 years (range 0.76–6.8 years). Oxygen saturation and vessel diameters were measured in the right eye. Semiquantitative grading of retinopathy according to international guidelines and red lesion count were performed on fundus photographs. Results Retinopathy grade according to the international semiquantitative grading system was unchanged. Arteriolar saturation increased by 0.75±0.15 percentage points per year of follow-up (p<0.0001). Venular saturation increased by 1.74±0.26 percentage points per year (p<0.0001) and arteriovenous difference decreased by 0.99±0.20 percentage points per year (p<0.0001). Arteriolar diameters decreased by 2.7±8.5μm (p<0.0001) between visits and venular diameters decreased by 2.4±9.1μm (p = 0.0002). Median increase in red lesion count between visits was 2 lesions (range -128 to 212 lesions, p<0.0001). The change in red lesion count and change in diameters did not correlate with the length of follow-up (p>0.44). Conclusions Oxygen saturation in larger retinal vessels can increase and arteriovenous difference can decrease over time in diabetic patients without any observable changes in retinopathy grade. The results suggest that changes in retinal oxygen saturation may precede progression of diabetic retinopathy or that oxygen saturation is more sensitive to disease progression than retinopathy grade.

Effects of Lactobacillus plantarum CJLP55 on Clinical Improvement, Skin Condition and Urine Bacterial Extracellular Vesicles in Patients with Acne Vulgaris: A Randomized, Double-Blind, Placebo-Controlled Study

Lactobacillus plantarum CJLP55 has anti-pathogenic bacterial and anti-inflammatory activities in vitro. We investigated the dietary effect of CJLP55 supplement in patients with acne vulgaris, a prevalent inflammatory skin condition. Subjects ingested CJLP55 or placebo (n = 14 per group) supplements for 12 weeks in this double-blind, placebo-controlled randomized study. Acne lesion count and grade, skin sebum, hydration, pH and surface lipids were assessed. Metagenomic DNA analysis was performed on urine extracellular vesicles (EV), which indirectly reflect systemic bacterial flora. Compared to the placebo supplement, CJLP55 supplement improved acne lesion count and grade, decreased sebum triglycerides (TG), and increased hydration and ceramide 2, the major ceramide species that maintains the epidermal lipid barrier for hydration. In addition, CJLP55 supplement decreased the prevalence of Proteobacteria and increased Firmicutes, which were correlated with decreased TG, the major skin surface lipid of sebum origin. CJLP55 supplement further decreased the Bacteroidetes:Firmicutes ratio, a relevant marker of bacterial dysbiosis. No differences in skin pH, other skin surface lipids or urine bacterial EV phylum were noted between CJLP55 and placebo supplements. Dietary Lactobacillus plantarum CJLP55 was beneficial to clinical state, skin sebum, and hydration and urine bacterial EV phylum flora in patients with acne vulgaris.

577-nm High-Power Optically Pumped Semiconductor Laser is Safe and Effective in The Treatment of Inflammatory Acne: A Prospective, Single-Center, Split-Face Comparative Study

Objective: This study aimed to appraise the efficacy of a 577 nm high-power optically pumped semiconductor laser (HOPSL) for the treatment of inflammatory acne.Methods: The study included 50 patients with acne vulgaris (inflammatory type), 14 men, and 36 females; patient ages ranged from 16 to 35 years. The left side of the face was treated with a single pass of a 577 nm high-power optically pumped semiconductor laser every 2 weeks for 3 sessions. Patients were examined prior to the first session and 4 weeks after the last session (Investigator's Global Assessment of acne severity, IGA; single lesion count).Results: At baseline, no statistically significant difference in the severity of inflammatory acne lesions between both sides was observed. One month after the final session, a significant improvement (IGA reduction of >50 percent) of the over-all severity of the acne was observed in 49 patients (98 percent) on laser-treated side versus 41 (82 percent) the control side of the face (P < .05). Accordingly, we found a significant reduction in the mean percentage of inflammatory papules, pustules, and nodules (79.33 vs 56.92, 78.04 vs 43.33, 64.85 vs 21.93 percent, respectively) (P<0.05). Side effects in the form of erythema and irritation during sessions were transient and tolerated by the patients.Conclusion: The 577 nm high-power optically pumped semiconductor laser is effective and safe for the treatment of inflammatory lesions (papules, pustules, and nodules) in acne patients.Running title: 577 nm high-power optically pumped semiconductor laser (HOPSL) for the treatment of inflammatory acne

Efficacy of Acupuncture in Improving Symptoms and Quality of Life of Patients With Acne Vulgaris: a Randomized Sham Acupuncture-controlled Trial

Objective: The aim of this study was to examine the effectiveness of acupuncture in treating the symptoms and QoL of patients with moderate or severe AV. Methods: Participants were randomly assigned (1:1) to receive 12 treatment sessions of acupuncture or sham acupuncture over 4 weeks with 24 weeks of follow-up. The primary outcome was the change from baseline in the Skindex-16 scale total score at treatment completion. Secondary outcomes included Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, and visual analogue scale scores for itch and pain evaluation. Results: There is no statistically significant between-group difference for the primary outcome and any secondary outcomes after 4 weeks of treatment and at 16 weeks and 28 weeks of follow-up, except for the Skindex-16 subscale (the emotions of participants with AV) at week 4 (P = 0.026). No serious adverse events occurred in two group. Conclusion: Acupuncture and sham acupuncture might both relieve the symptoms of patients with moderate or severe AV, reduce the number and degree of inflammatory lesion counts, and improve QoL. Trial registration number: ChiCTR-1900023649 Chinese Clinical Trial Registry

Predictive Values of Location and Volumetric MRI Injury Patterns for Neurodevelopmental Outcomes in Hypoxic-Ischemic Encephalopathy Neonates

Hypoxic-ischemic encephalopathy (HIE) is a severe neonatal complication with up to 40–60% long-term morbidity. This study evaluates the distribution and burden of MRI changes as a prognostic indicator of neurodevelopmental (ND) outcomes at 18–24 months in HIE infants who were treated with therapeutic hypothermia (TH). Term or late preterm infants who were treated with TH for HIE were analyzed between June 2012 and March 2016. Brain MRI scans were obtained from 107 TH treated infants. For each infant, diffusion weighted brain image (DWI) sequences from a 3T Siemens scanner were obtained for analysis. Of the 107 infants, 36 of the 107 infants (33.6%) had normal brain MR images, and 71 of the 107 infants (66.4%) had abnormal MRI findings. The number of clinical seizures was significantly higher in the abnormal MRI group (p < 0.001) than in the normal MRI group. At 18–24 months, 76 of the 107 infants (70.0%) showed normal ND stages, and 31 of the 107 infants (29.0%) exhibited abnormal ND stages. A lesion size count >500 was significantly associated with abnormal ND. Similarly, the total lesion count was larger in the abnormal ND group (14.16 vs. 5.29). More lesions in the basal ganglia (BG) and thalamus areas and a trend towards more abnormal MRI scans were significantly associated with abnormal ND at 18–24 months. In addition to clinical seizure, a larger total lesion count and lesion size as well as lesion involvement of the basal ganglia and thalamus were significantly associated with abnormal neurodevelopment at 18–24 months.

LesionQuant for Assessment of MRI in Multiple Sclerosis—A Promising Supplement to the Visual Scan Inspection

Background and Goals: Multiple sclerosis (MS) is a central nervous system inflammatory disease where magnetic resonance imaging (MRI) is an important tool for diagnosis and disease monitoring. Quantitative measurements of lesion volume, lesion count, distribution of lesions, and brain atrophy have a potentially significant value for evaluating disease progression. We hypothesize that utilizing software designed for evaluating MRI data in MS will provide more accurate and detailed analyses compared to the visual neuro-radiological evaluation.Methods: A group of 56 MS patients (mean age 35 years, 70% females and 96% relapsing-remitting MS) was examined with brain MRI one and 5 years after diagnosis. The T1 and FLAIR brain MRI sequences for all patients were analyzed using the LesionQuant (LQ) software. These data were compared with data from structured visual evaluations of the MRI scans performed by neuro-radiologists, including assessments of atrophy, and lesion count. The data from LQ were also compared with data from other validated research methods for brain segmentation, including assessments of whole brain volume and lesion volume. Correlations with clinical tests like the timed 25-foot walk test (T25FT) were performed to explore additional value of LQ analyses.Results: Lesion count assessments by LQ and by the neuro-radiologist were significantly correlated one year (cor = 0.92, p = 2.2 × 10−16) and 5 years (cor = 0.84, p = 2.7 × 10−16) after diagnosis. Analyzes of the intra- and interrater variability also correlated significantly (cor = 0.96, p &lt; 0.001, cor = 0.97, p &lt; 0.001). Significant positive correlation was found between lesion volume measured by LQ and by the software Cascade (cor = 0.7, p &lt; 0.001. LQ detected a reduction in whole brain percentile &gt;10 in 10 patients across the time-points, whereas the neuro-radiologist assessment identified six of these. The neuro-radiologist additionally identified five patients with increased atrophy in the follow-up period, all of them displayed decreasing low whole brain percentiles (median 11, range 8–28) in the LQ analysis. Significant positive correlation was identified between lesion volume measured by LQ and test performance on the T25FT both at 1 and 5 years after diagnosis.Conclusion: For the number of MS lesions at both time-points, we demonstrated strong correlations between the assessments done by LQ and the neuro-radiologist. Lesion volume evaluated with LQ correlated with T25FT performance. LQ-analyses classified more patients to have brain atrophy than the visual neuro-radiological evaluation. In conclusion, LQ seems like a promising supplement to the evaluation performed by neuro-radiologists, providing an automated tool for evaluating lesions in MS patients and also detecting early signs of atrophy in both a longitudinal and cross-sectional setting.