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Higher levels of daily physical activity are associated with better skin microvascular function in type 2 diabetes-The Maastricht Study.
Sörensen, BM, van der Heide, FCT, Houben, AJHM, Koster, A, T J M Berendschot, T, S A G Schouten, J, Kroon, AA, van der Kallen, CJH, Henry, RMA, van Dongen, MCJM, et al
Microcirculation (New York, N.Y. : 1994). 2020;(4):e12611
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Abstract
OBJECTIVE Physical activity may provide a means for the prevention of cardiovascular disease via improving microvascular function. Therefore, this study investigated whether physical activity is associated with skin and retinal microvascular function. METHODS In The Maastricht Study, a population-based cohort study enriched with type 2 diabetes (n = 1298, 47.3% women, aged 60.2 ± 8.1 years, 29.5% type 2 diabetes), we studied whether accelerometer-assessed physical activity and sedentary time associate with skin and retinal microvascular function. Associations were studied by linear regression and adjusted for major cardiovascular risk factors. In addition, we investigated whether associations were stronger in type 2 diabetes. RESULTS In individuals with type 2 diabetes, total physical activity and higher-intensity physical activity were independently associated with greater heat-induced skin hyperemia (regression coefficients per hour), respectively, 10 (95% CI: 1; 18) and 36 perfusion units (14; 58). In individuals without type 2 diabetes, total physical activity and higher-intensity physical activity were not associated with heat-induced skin hyperemia. No associations with retinal arteriolar %-dilation were identified. CONCLUSION Higher levels of total and higher-intensity physical activity were associated with greater skin microvascular vasodilation in individuals with, but not in those without, type 2 diabetes.
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Evaluation of tolerability and skin changes after application of topical antiaging products based on Sibanid SG®, plant stem cells and regenerative and biostimulating active ingredients.
D'andrea, M, Perrotta, A, Ferrillo, M, Cantelli, M, Donnarumma, M, Fabbrocini, G
Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia. 2019;(1):6-13
Abstract
BACKGROUND The oxidative stress, the UV radiations, the matrix metalloproteinases (MMPs) and the hyaluronidase enzyme play an extremly important role in skin aging processes, leading an increasing production of elastase, collagenase and hyaluronidase that brings to degradation of collagen, elastin and hyaluronic acid respectively. They are responsible to provide strength, elasticity and moisture to the skin. Innovative devices were developed based on the effective ingredients against hyaluronidase and MMP. The inhibition of the destructuring enzymes of the dermis is the main mechanism of action of Bioliftan treatment, and this process is mainly addressed to hyaluronidase and MMP inhibition. The aim of our study was to evaluate the efficacy, tolerability and skin changes induced by antiaging topical based on Sibanid SG®, plant stem cells and regenerative and biostimulating active ingredients. The products tested are Bioliftan Day cream and Bioliftan concentrate. METHODS All parameters were evaluated before the beginning of treatment (T0), and 60 (T1) days later. The evaluation of the effectiveness of the products was performed by clinical examination, photographic and instrumental documentation by corneometry, X-rite, elastometry, Moisture Meter EpiD, Confocal microscopy. RESULTS The products tested after 60 days have induced an increase of hydration of the external cutaneous layers (P<0.0001), skin hydration (P<0.0001), skin brightness (P<0.01), skin elasticity (P<0.0001). All results were statistically significant. All volunteers completed the study. No patients reported side-effects. All results were confirmed by confocal microscopy. CONCLUSIONS Our study evaluated efficacy, tolerability and skin changes after 60 days of Bioliftan day cream and Bioliftan serum concentrate application on the skin aged. Our study has shown an excellent skin tollerance of the products tested.
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A Prospective Comparative Study in Skin Antiseptic Solutions for Posterior Spine Surgeries: Chlorhexidine-Gluconate Ethanol Versus Povidone-Iodine.
Yoshii, T, Hirai, T, Yamada, T, Sakai, K, Ushio, S, Egawa, S, Yuasa, M, Kato, T, Inose, H, Kawabata, S, et al
Clinical spine surgery. 2018;(7):E353-E356
Abstract
STUDY DESIGN This is a prospective comparative study. OBJECTIVE We evaluated the efficacy of 2 standard antiseptic solutions, chlorhexidine-gluconate (CHG) and povidone-iodine (PD-I), in eliminating bacterial pathogens from surgical sites in posterior spine surgeries. SUMMARY OF BACKGROUND DATA Previous studies have shown that CHG is more effective for skin antisepsis than PD-I in joint surgeries. However, few studies have investigated the preoperative use of antiseptic solutions in spine surgery. MATERIALS AND METHODS A total of 190 patients who received posterior spine surgeries were included in this study. The patients were allocated to the group treated with 0.5% CHG in ethanol (N=98) or 10% PV-I (N=92). Sterile culture swabs were used to obtain samples from the skin area adjacent to the planned incision site before preparation, after preparation, and after wound closure. RESULTS No differences were found between the CHG-treated and the PD-I-treated groups in the patients' age, sex, disease status, surgical site, operating time, and intraoperative blood loss. Before surgical skin preparation, bacteria grew in the cultures of specimens of 83.7% of the patients; no significant difference was found between the 2 groups. The common organisms isolated from both the cervical and lumbar spine surgical sites were Staphylococcus sp., Corynebacterium sp., and Bacillus sp. After the skin preparation, there were no significant differences observed in the culture positive rate between the CHG (3.1%) and PD-I (5.1%) (P=0.49) solutions. The culture positive rates became higher after wound closure (preop=4.2%, postop=8.4%; P=0.07). The positive rate after wound closure in the CHG-treated group (5.1%) was smaller than in the PD-I-treated group (14.1%) (P=0.046). However, no difference was found in infection rates between the 2 groups. CONCLUSIONS While CHG-ethanol and PD-I were equally effective at eliminating the bacterial flora from the surgical site, CHG-ethanol showed a more favorable long-lasting effect for skin antisepsis in posterior spine surgeries.
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Improvement of skin condition in striae distensae: development, characterization and clinical efficacy of a cosmetic product containing Punica granatum seed oil and Croton lechleri resin extract.
Bogdan, C, Iurian, S, Tomuta, I, Moldovan, M
Drug design, development and therapy. 2017;:521-531
Abstract
Striae distensae are a frequent skin condition associated with pregnancy, weight change or lack of skin elasticity. The aim of this research was to obtain a topical product containing herbal active ingredients with documented antioxidant and anti-inflammatory activity (Punica granatum seed oil and Croton lechleri resin extract) and demonstrate its positive effect on prevention and treatment of striae distensae. First, the cream base formulation was optimized through experimental design. Secondly, the cream containing the two active ingredients was investigated in an interventional nonrandomized clinical trial. The clinical outcome was assessed through biophysical parameters and ultrasonographic evaluation. The state of the skin was evaluated by biophysical measurements and ultrasonography at the beginning of the study and after 3 and 6 weeks. The experimental design was successfully used to set the best ranges for the technological and formulation factors to obtain a cosmetic formulation with optimal characteristics. The study of clinical efficacy on the optimal formulation revealed an increase in the dermis thickness, hydration and elasticity values in both groups after 6 weeks of cream application. The new oil-in-water cream containing P. granatum seed oil and C. lechleri resin extract can be helpful in the prevention or improving of skin changes associated with striae.
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Skin Irritation and Sensitization Potential of Fixed-Dose Combination of Diclofenac 1% and Menthol 3% Topical Gel: Results of Two Phase I Patch Studies.
Liu, DJ, Collaku, A, Dosik, JS
Drug research. 2017;(2):119-126
Abstract
Phase I, randomized, controlled patch studies were conducted to evaluate skin sensitization and irritation potential of a new gel formulation containing 1% diclofenac and 3% menthol as a fixed-combination product.In study A, healthy volunteers were exposed to 4 test patches containing 1% diclofenac+3% menthol, diclofenac, menthol, or placebo gels during an induction (nine 48 to 72-h applications) and challenge phase (one 48-h application). Some subjects were re-challenged to evaluate suspected sensitization. Study B participants underwent 21 consecutive 24-h patch applications of the 4 treatments from study A, 0.2% sodium lauryl sulfate (positive control), 0.9% saline, and a marketed gel (1% diclofenac, Voltaren). Application sites were visually scored by blinded observers for skin sensitization/irritation.In study A, 77% of participants showed minimal erythema and signs of glazing and peeling with 1% diclofenac+3% menthol by the end of the induction phase, which diminished during the challenge phase. Similar patterns were seen with menthol gel. Only 1 subject exhibited possible sensitization to 1% diclofenac+3% menthol. In study B, mean cumulative irritation score with 1% diclofenac+3% menthol was significantly higher (P<0.0001) vs. reference treatments; however, the positive control failed to produce the expected level of irritation. No treatment-related adverse events were reported.The sensitization and irritation potential of 1% diclofenac+3% menthol was greater than with the reference treatments. Comparison with positive control was not possible because it did not produce irritation under semiocclusive patch conditions.
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Effect of mechanical vibration on transcutaneous oxygen levels in the feet of type 2 diabetes mellitus patients.
Rodríguez Reyes, G, Núñez Carrera, L, Alessi Montero, A, Solís Vivanco, A, Quiñones Uriostegui, I, Pérez Sanpablo, AI
Medicina clinica. 2017;(1):16-19
Abstract
BACKGROUND AND OBJECTIVE Foot conditions in patients with diabetes mellitus (DM) are major causes of morbidity and disability. Whole body vibration may promote blood circulation in the lower limbs, hence facilitating perfusion and promoting the supply of nutrients and oxygen to comprised tissues. Transcutaneous oxygen levels (TcPO2)>40mmHg in cases of diabetic foot syndrome are associated with a good prognosis in the resolution of ulcers. The objective of this study was to determine whether whole body vibration favors some parameters of interest related to complications associated with the diabetic foot syndrome. PATIENTS AND METHODS Fifty-four patients with DM were included in a 12-week exercise program based on whole body vibration. Glycemic control was determined on the basis of the patients' levels of glycated hemoglobin (HbA1c); sensitivity and TcPO2 levels of each foot were also recorded. Assessments were performed prior to initiating the whole body vibration program and at the end of it. RESULTS No significant changes were observed in the patients' HbA1c (P=.442) levels or sensitivity (P=.07). A significant 7mmHg increase (P<.0001; effect size: d=0.53) was observed in the concentration of TcPO2. CONCLUSIONS Whole body vibration may increase TcPO2 levels with useful implications for the prevention or management of complications associated with restricted blood perfusion in the diabetic foot syndrome.
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Clopidogrel Improves Skin Microcirculatory Endothelial Function in Persons With Heightened Platelet Aggregation.
Salimi, S, Lewis, JP, Yerges-Armstrong, LM, Mitchell, BD, Saeed, F, O'Connell, JR, Perry, JA, Ryan, KA, Shuldiner, AR, Parsa, A
Journal of the American Heart Association. 2016;(11)
Abstract
BACKGROUND Platelet activation can lead to enhanced oxidative stress, inflammatory response, and endothelial dysfunction. To quantify the effects of platelet inhibition on endothelial function, we assessed platelet activity of healthy persons before and after clopidogrel administration and evaluated its effects on endothelial function. We hypothesized that clopidogrel, by attenuating platelet activity, would result in enhanced endothelial function. METHODS AND RESULTS Microcirculatory endothelial function was quantified by laser Doppler flowmetry (LDF) mediated by thermal hyperemia (TH) and postocclusive reactive hyperemia, respectively, in 287 and 241 relatively healthy and homogenous Old Order Amish persons. LDF and platelet aggregation measures were obtained at baseline and after 7 days of clopidogrel administration. Our primary outcome was percentage change in post- versus preclopidogrel LDF measures. Preclopidogrel TH-LDF and platelet aggregation were higher in women than in men (P<0.001). Clopidogrel administration was associated with ≈2-fold higher percentage change in TH-LDF in participants with high versus low baseline platelet aggregation (39.4±10.1% versus 17.4±5.6%, P=0.03). Clopidogrel also increased absolute TH-LDF measures in persons with high platelet aggregation (1757±766 to 2154±1055, P=0.03), with a more prominent effect in women (1909±846 to 2518±1048, P=0.001). There was no evidence that clopidogrel influenced postocclusive reactive hyperemia LDF measures. CONCLUSIONS The administration of clopidogrel in healthy persons with high baseline platelet aggregation results in improved TH-induced microcirculatory endothelial function. These data suggest that clopidogrel may have a beneficial effect on microcirculatory endothelial function, presumably through antiplatelet activity, and may confer additional vascular benefits. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00799396.
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N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial.
Grant, JE, Chamberlain, SR, Redden, SA, Leppink, EW, Odlaug, BL, Kim, SW
JAMA psychiatry. 2016;(5):490-6
Abstract
IMPORTANCE Excoriation (skin-picking) disorder (SPD) is a disabling, underrecognized condition in which individuals repeatedly pick at their skin, leading to noticeable tissue damage. To date, there has been no clearly effective pharmacologic or psychological treatment for SPD. OBJECTIVE To determine whether N-acetylcysteine, an amino acid that appears to restore extracellular glutamate concentration in the nucleus accumbens, will be more effective than placebo in reducing compulsive picking behavior. DESIGN, SETTING, AND PARTICIPANTS A randomized, double-blind trial was conducted at ambulatory care centers at the University of Minnesota (September 12, 2011, to June 15, 2012) and the University of Chicago (December 17, 2012, to June 26, 2015) and included 66 adults with SPD. Data analysis was performed from July 16 to September 9, 2015. INTERVENTIONS N-acetylcysteine (dosing range, 1200-3000 mg/d) or placebo was administered for 12 weeks. MAIN OUTCOMES AND MEASURES Participants were assessed using measures of skin-picking severity, including the modified Yale-Brown Obsessive Compulsive Scale (NE-YBOCS); total scores range from 0 to 40, with higher scores reflective of greater symptom severity. Another measure of skin-picking severity was the Clinical Global Impression-Severity Scale; total scores range from 1 (normal) to 7 (among the most extremely ill patients), and improvement ratings range from 7 (very much worse) to 1 (very much improved). Selected cognitive tasks included the Intra-dimensional/Extra-dimensional Shift Task to examine cognitive flexibility, with the key outcome measures being the number of errors, and Stop-Signal Reaction Time task, which evaluates motor inhibition. Outcomes were examined using a linear mixed-effects model. RESULTS Of the 66 participants (31 randomized to placebo and 35 to N-acetylcysteine) included in the analysis, 59 (89%) were women; mean (SD) age was 34.8 (11.0) years. Compared with placebo, N-acetylcysteine treatment was associated with significant improvements in the NE-YBOCS. At baseline, NE-YBOCS scores were 18.9 and 17.9 for the treatment and placebo groups, respectively, and at 12 weeks, the scores were 11.5 and 14.1 for the treatment and placebo groups, respectively (P = .048). For the Clinical Global Impression-Severity scale, baseline scores were 3.5 and 4.0 and 12-week scores were 3.0 and 4.2, respectively (P = .003). These effects were significant both in terms of treatment by time interactions and post hoc tests at 1 or more individual time points. At the study's end point, of the 53 participants who completed the study, 15 of the 32 participants (47%) receiving N-acetylcysteine were much or very much improved compared with 4 of the 21 participants (19%) receiving placebo (P = .03). There were no significant differences between the active and placebo arms in terms of psychosocial functioning. CONCLUSIONS AND RELEVANCE N-acetylcysteine treatment resulted in significant reductions in skin-picking symptoms and was well tolerated. The glutamate system may prove a beneficial target in treating SPD and other compulsive behaviors. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01063348.
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Association Between Arterial Stiffness and Skin Microvascular Function: The SUVIMAX2 Study and The Maastricht Study.
van Sloten, TT, Czernichow, S, Houben, AJ, Protogerou, AD, Henry, RM, Muris, DM, Schram, MT, Sep, SJ, Dagnelie, PC, van der Kallen, CJ, et al
American journal of hypertension. 2015;(7):868-76
Abstract
BACKGROUND It has been hypothesized that arterial stiffness leads to generalized microvascular dysfunction and that individuals with type 2 diabetes mellitus (T2DM) are particularly prone to the detrimental effects of arterial stiffness. However, evidence for an association between stiffness and markers of generalized microvascular dysfunction is lacking. We therefore investigated the association between arterial stiffness and skin microvascular function in individuals without and with T2DM. METHODS Cross-sectional data were used of The Supplementation en Vitamines et Mineraux Antioxydants 2 (SUVIMAX2) Study (n = 284/62.2 years/48.6% women/0% T2DM (by design)) and The Maastricht Study (n = 737/59.7 years/45.2% women/28.8% T2DM (by design)). Arterial stiffness was determined by carotid-femoral pulse wave velocity (cfPWV). Skin capillaroscopy was used to determine capillary density at baseline, and during reactive hyperemia and venous congestion. Laser Doppler flowmetry was used to assess acetylcholine- and local heating-induced vasoreactivity, and skin flowmotion. RESULTS In The SUVIMAX2 Study, cfPWV (per +1 SD) was not associated with baseline capillary density (regression coefficient: -0.48 (95% confidence interval: 2.37; 1.41)) or capillary recruitment during venous congestion (0.54% (-0.74; 1.81%)). In addition, cfPWV was not associated with acetylcholine (-0.02% (-0.14; 0.10%)) or local heating-induced vasoreactivity (0.03% (-0.07; 0.12%)). In The Maastricht Study, in individuals without T2DM, cfPWV was not associated with baseline capillary density (-1.20 (-3.17; 0.77)), and capillary recruitment during reactive hyperemia (1.22% (-0.41; 2.84%)) or venous congestion (1.50% (-0.25; 3.25%)). In addition, cfPWV was not associated with flowmotion (-0.01 (-0.07; 0.06)). Results were adjusted for age and sex. Additional adjustments for confounders did not materially change these results. Results were qualitatively similar in individuals with T2DM. CONCLUSIONS Arterial stiffness is not associated with skin microvascular function, irrespective of the presence of T2DM.
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A phase 2a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate-to-severe psoriasis.
Papp, K, Pariser, D, Catlin, M, Wierz, G, Ball, G, Akinlade, B, Zeiher, B, Krueger, JG
The British journal of dermatology. 2015;(3):767-76
Abstract
BACKGROUND Many immune-mediated disorders, including psoriasis, involve cytokine signalling via Janus kinase (JAK) enzymes. ASP015K (also designated JNJ-54781532), a novel oral JAK inhibitor, has shown moderate selectivity for JAK3 over JAK1 and JAK2 in enzyme assays. OBJECTIVES The objective of this study was to evaluate the efficacy and safety of escalating, sequentially grouped, doses of ASP015K vs. placebo in patients with moderate-to-severe psoriasis. METHODS This phase 2a multicentre, double-blind, randomized, placebo-controlled study (NCT01096862) enrolled 124 patients with moderate-to-severe plaque psoriasis. Five sequential ASP015K cohorts were enrolled, consisting of four twice-daily dosing groups (10, 25, 60, 100 mg) and one once-daily dosing group (50 mg) for 6 weeks. RESULTS The primary efficacy end point [mean change in Psoriasis Area and Severity Index score from baseline to end of treatment (EOT; day 42)] significantly favoured ASP015K (overall treatment effect; P < 0.001) vs. placebo, with greater improvements at higher doses. By EOT, the secondary end points [Physician Static Global Assessment (PSGA) score, percentage of patients achieving PSGA success, and change in percentage, body surface area (BSA)] also improved with ASP015K vs. placebo (P < 0.001 for PSGA score and BSA; P < 0.01 for PSGA success). Epidermal thickness and proliferation decreased from baseline with ASP015K vs. placebo. ASP015K was generally well tolerated, with no serious adverse events (AEs) reported. CONCLUSIONS In patients with moderate-to-severe psoriasis, ASP015K demonstrated dose-dependent improvements in clinical and histological measures of severity over 6 weeks of treatment. At all doses, ASP015K was well tolerated, with no reported serious AEs.