Topical application of Apremilast in the treatment of mild to moderate psoriasis

2021 ◽  
Vol 9 (1) ◽  
pp. 12-16
Author(s):  
Srikanth Kalakoti ◽  
Narasimharao Netha G
Keyword(s):  
Treatment Options ◽  
Controlled Study ◽  
Proof Of Concept ◽  
Double Blind ◽  
Average Percentage ◽  
Before And After ◽  
Topical Dosage ◽  
Associated Variety ◽  
Topical Dosage Forms ◽  
Topical Gels

Mild to moderate psoriasis is highly prevalent in about 80% of the global psoriatic population. Current available treatment options for mild to moderate psoriasis are topical dosage forms and are associated variety of setbacks. To address these setbacks, Apremilast topical gels, 2% & 4%, w/w were developed, and a clinical proof of concept study (POC) was performed to establish efficacy and safety. A single centre randomized, double-blind, placebo-controlled study was conducted with apremilast topical gels 2% & 4% w/w in adult mild to moderate psoriatic patients for 12 weeks. The efficacy of the gels was evaluated by comparing the PASI scores before and after treatment of 12 weeks. Both gels exhibited a significant reduction in PASI values when compared with baseline PASI scores. An average percentage inhibition of PASI with test products, i.e. 2% and 4% w/w Apremilast topical gels, are about 46.8% and 34.6%, respectively, after 12 weeks of treatment. The results confirm that the apremilast topical gels are a good option for the treatment of mild to moderate psoriasis and have to be explored further. 

scholarly journals Topical Application of Apremilast in the Treatment of Mild to Moderate Psoriasis

2021 ◽  
Vol 2 (1) ◽  
pp. 01-10
Author(s):  
Srikanth Kalakoti
Keyword(s):  
Side Effects ◽  
Treatment Options ◽  
Unmet Need ◽  
Autoimmune Disorder ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Average Percentage ◽  
Topical Dosage ◽  
Topical Gels

Background: Psoriasis is a chronic, autoimmune disorder that affects the skin and joints with an approximate global prevalence of 2–3%. Mild to moderate psoriasis is highly prevalent in about 80% of the global psoriatic population (2-3%). Currently available treatment options for mild to moderate psoriasis are topical dosage forms. Though a variety of topical formulations available, they are associated with different side effects. There is an unmet need for a product that can be used for a prolonged period with minimal side effects. Hence, Apremilast gel was developed and clinical proof of concept study (POC) was performed to investigate the efficacy and safety in mild to moderate psoriasis patients. Methods: A single-center randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of apremilast topical gels 2% & 4% w/w, in adult mild to moderate psoriatic patients for 12 weeks. Patients were examined at weeks 0, 2, 4, 8, and 12 weeks to assess the efficacy and safety. At 0 and 8 weeks, blood samples were collected to investigate the pharmacokinetics. The significance in % recovery was calculated statistically. Results: Both gels exhibited a significant reduction in PASI values when compared with baseline PASI scores. The average percentage inhibition of PASI with test products i.e. 2% and 4% w/w Apremilast topical gels is about 46.8% and 34.6% respectively after 12 weeks of treatment. Both the test products have not shown any adverse effects, hematological & biochemical changes and have exhibited Cmax less than 20ng/ml after 6 hours of application. Conclusion: Results have shown that topically applied apremilast could be an effective and safe option for the management of mild to moderate psoriasis.

scholarly journals Cerebellar rTMS in PSP: a Double-Blind Sham-Controlled Study Using Mobile Health Technology

2021 ◽  
Author(s):  
Andrea Pilotto ◽  
Maria Cristina Rizzetti ◽  
Alberto Lombardi ◽  
Clint Hansen ◽  
Michele Biggi ◽  
...  
Keyword(s):  
Digital Technology ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Health Technology ◽  
Controlled Study ◽  
Double Blind ◽  
Non Invasive ◽  
Lower Back ◽  
Before And After ◽  
Double Blind Design ◽  
Theta Burst

AbstractThere are no effective treatments in progressive supranuclear palsy (PSP). The aim of this study was to test the efficacy of theta burst repetitive transcranial magnetic stimulation (rTMS) on postural instability in PSP. Twenty PSP patients underwent a session of sham or real cerebellar rTMS in a crossover design. Before and after stimulation, static balance was evaluated with instrumented (lower back accelerometer, Rehagait®, Hasomed, Germany) 30-s trials in semitandem and tandem positions. In tandem and semitandem tasks, active stimulation was associated with increase in time without falls (both p=0.04). In the same tasks, device-extracted parameters revealed significant improvement in area (p=0.007), velocity (p=0.005), acceleration and jerkiness of sway (p=0.008) in real versus sham stimulation. Cerebellar rTMS showed a significant effect on stability in PSP patients, when assessed with mobile digital technology, in a double-blind design. These results should motivate larger and longer trials using non-invasive brain stimulation for PSP patients.

Oral Desensitization in Papular Urticaria in Children

2002 ◽  
Vol 32 (3) ◽  
pp. 142-145 ◽  
Author(s):  
Susana Giraldi ◽  
Ramón Ruiz-Maldonado ◽  
Lourdes Tamayo ◽  
Cristina Sosa-de-Martínez
Keyword(s):  
Vaccine Efficacy ◽  
Oral Vaccine ◽  
Effective Means ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Before And After ◽  
Insect Bites ◽  
Oral Desensitization

Papular urticaria (PU) is among the commonest skin ailments in children. Induced specific desensitization to insect bites is theoretically an effective means of prevention of PU. In this double blind placebo controlled study, an oral vaccine prepared from insect saliva was compared with placebo (stable vaccine solvent). Vaccine and placebo effectiveness were tested by counting active PU lesions, serum eosinophils, and IgE, before and after 4 months of treatment. Statistically significant differences between oral vaccine and placebo were not found in the clinical or the immunological variables tested. We conclude that, although a lack of oral vaccine efficacy was suspected, larger study samples are needed to strengthen our conclusion.

scholarly journals Beta alanine supplementation effects on metabolic contribution and swimming performance

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Matheus Silva Norberto ◽  
Ricardo Augusto Barbieri ◽  
Danilo Rodrigues Bertucci ◽  
Ronaldo Bucken Gobbi ◽  
Eduardo Zapaterra Campos ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Energy Demand ◽  
Swimming Performance ◽  
Controlled Study ◽  
Double Blind ◽  
Repeated Measures Anova ◽  
Beta Alanine ◽  
Before And After ◽  
The Difference ◽  
And Performance

Abstract Background Investigations of β-alanine supplementation shows effects on metabolic (aerobic and anaerobic) participation and performance on swimming by a possible blood acidosis buffering. Considering this background, the objective of the present study was to analyze the effects of β-alanine supplementation on metabolic contribution and performance during 400-m swim. Methods Thirteen competitive swimmers underwent a 6-week, double-blind placebo-controlled study, ingesting 4.8 g.day− 1 of β-alanine or placebo. Before and after the supplementation period, the total anaerobic contribution (TAn) and 30-s all-out tethered swimming effort (30TS) were assessed. Anaerobic alactic (AnAl) and lactic energy (AnLa) was assumed as the fast component of excess post-exercise oxygen consumption and net blood lactate accumulation during exercise (∆[La−]), respectively. Aerobic contribution (Aer) was determined by the difference between total energy demand and TAn. In addition to conventional statistical analysis (Repeated measures ANOVA; p > 0.05), a Bayesian repeated measures ANOVA was used to evidence the effect probability (BFincl). Results No differences and effects were found between groups, indicating no supplementation effects. Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BFincl: 25.02); absolute AnLa (p: 0.002; BFincl: 12.61), fatigue index (p > 0.001; BFincl: 63.25) and total anaerobic participation (p: 0.008; BFincl: 4.89). Conclusions Thus, the results demonstrated that all changes presented were evidenced as a result of exposure to the training period and β-alanine supplementation doesn’t affect metabolic contribution and performance during 400-m freestyle.

scholarly journals Salivary α-Amylase Levels after Yohimbine Challenge in Healthy Men

2006 ◽  
Vol 91 (12) ◽  
pp. 5130-5133 ◽  
Author(s):  
Ulrike Ehlert ◽  
Katja Erni ◽  
Gundula Hebisch ◽  
Urs Nater
Keyword(s):  
Blood Pressure ◽  
Flow Rate ◽  
Academic Research ◽  
Cardiovascular Effects ◽  
Salivary Flow ◽  
Research Unit ◽  
Salivary Flow Rate ◽  
Controlled Study ◽  
Double Blind ◽  
Before And After

Abstract Context: We and others have previously shown that standardized psychosocial stress significantly increases salivary α-amylase (sAA), but it remains unclear whether sAA reflects autonomic nervous system activation. Objective: The aim of this study was to assess cardiovascular effects and sAA and catecholamine secretion after iv injection of yohimbine. Design and Setting: We conducted a randomized double-blind placebo-controlled study at an academic research unit. Participants: Thirteen healthy males (aged 20–28 yr) were examined. Intervention: Participants received iv injection of yohimbine (0.4 μg/kg) or placebo (0.9% NaCl). Main Outcome Measures: Eight saliva and blood samples were taken before and after injection for the assessment of salivary flow rate and sAA and catecholamine concentrations. In addition, blood pressure, mood, and anxiety were assessed repeatedly. Results: Yohimbine induced increases of sAA activity and output in comparison to placebo (P = 0.034). Blood pressure (P < 0.001), salivary flow rate (P = 0.007), and catecholamines (P < 0.001) were also significantly increased. No significant correlations between α-amylase parameters and catecholamines were observed. Conclusions: The results indicate that yohimbine administration activates not only autonomic parameters but also sAA via adrenergic mechanisms, suggesting that sAA might be an indirect indicator of the central sympathetic system.

scholarly journals Circulating levels of incretin hormones and amylin in the fasting state and after oral glucose in GH-deficient patients before and after GH replacement: a placebo-controlled study

2000 ◽  
pp. 593-599 ◽  
Author(s):  
JO Jorgensen ◽  
AM Rosenfalck ◽  
S Fisker ◽  
B Nyholm ◽  
MS Fineman ◽  
...  
Keyword(s):  
Placebo Group ◽  
Pancreatic Beta Cells ◽  
Plasma Concentrations ◽  
Controlled Study ◽  
Oral Glucose ◽  
Fasting State ◽  
Gh Treatment ◽  
Double Blind ◽  
Gh Replacement ◽  
Before And After

OBJECTIVE: Hyperinsulinemia in association with GH excess is considered a compensatory response to insulin resistance, but the possibility of alternative insulinotropic mechanisms has not been investigated in vivo. It is also unknown how GH influences the secretion from pancreatic beta-cells of amylin, a peptide which regulates prandial glucose homeostasis and may be linked to development of beta-cell dysfunction. We therefore measured plasma concentrations of two gut insulinotropic hormones, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulin-releasing peptide (GIP), and total as well as non-glycosylated amylin, in 24 GH-deficient adults before and after 4 months of GH replacement (daily evening injections of 2 IU GH/m). DESIGN: Double-blind, placebo-controlled, parallel study. METHODS: All participants underwent an oral glucose tolerance test (OGTT) at 0 and 4 months. RESULTS: A 33% suppression of fasting GLP-1 concentrations was measured in the GH group at 4 months (P=0.02), whereas a non-significant increase occurred in the placebo group (P=0.08). Fasting levels of GIP and amylin did not change significantly after 4 months in either group. The incremental response in GLP-1 during the OGTT was significantly lower after GH treatment as compared with both baseline (P=0.02) and the response in the placebo group (P=0. 03). The stimulation of GIP secretion following OGTT was similar on all occasions. The OGTT-induced incremental response in non-glycosylated amylin was moderately elevated after GH treatment as compared with placebo (P=0.05). Plasma concentrations of glucose and insulin, both in the fasting state and after the OGTT, were higher after GH treatment, but the ratio between amylin and insulin remained unchanged. CONCLUSIONS: GH-induced hyperinsulinemia is accompanied by proportionate elevations in amylin concentrations and a blunting of gut GLP-1 secretion. The mechanisms underlying the suppression of GLP-1 remain to be elucidated.

Taste preferences for oral nutrition supplements in patients before and after pelvic radiotherapy: A double-blind controlled study

2006 ◽  
Vol 25 (6) ◽  
pp. 906-912 ◽  
Author(s):  
Camilla McGough ◽  
Natalie Peacock ◽  
Claire Hackett ◽  
Christine Baldwin ◽  
Andrew Norman ◽  
...  
Keyword(s):  
Controlled Study ◽  
Taste Preferences ◽  
Pelvic Radiotherapy ◽  
Double Blind ◽  
Oral Nutrition ◽  
Before And After

scholarly journals Endoxifen, A new hope for Bipolar Disorder

2021 ◽  
Vol 71 (11) ◽  
pp. 2685-2682
Author(s):  
Muneeba Amin ◽  
Alviya Shafique ◽  
Muhammad Yusuf Hafiz
Keyword(s):  
Bipolar Disorder ◽  
Psychiatric Disorders ◽  
Intracellular Signaling ◽  
Protein C ◽  
Kinase Inhibitors ◽  
Treatment Options ◽  
Controlled Study ◽  
Manic Depressive Illness ◽  
Current Standard ◽  
Double Blind

Bipolar Disorder (BD), originally called manic depressive illness, is one of the most challenging and disabling psychiatric disorders to manage with an estimated life time prevalence of 1.02%. (1) One of the challenges is limitations in our understanding of the pathophysiology of the disorder which ultimately will lead to better treatment options. Despite available treatment options, literature reports breakthrough episodes in treated groups ranging from 40% to 60%. (2) This makes it even more crucial to gain more insight into the pathophysiology. Advances in molecular neuropsychiatry have reported that bipolar disorder is associated with overactive protein C kinase intracellular signaling. (3) Reportedly, lithium and valproate are protein C kinase inhibitors. Research has shown promise in effectiveness of Endoxifen. A multicenter, double-blind, active-controlled study was conducted using Endoxifen compared with Divalproex, the current standard treatment, in patients with BD. This new protein kinase C inhibitor has shown effectiveness in the treatment of acute mania and mixed mania. (4) One of the many advantages include similar efficacy as Divalproax without inducing thrombocytopenia and reportedly no need for drug monitoring due to wide therapeutic index is one of the reasons which results in decreased compliance. Additionally, it crosses the blood-brain barrier independent of CYP-2D6 metabolism. (4) With regards to disadvantages, cost effectiveness is a major hurdle. These new insights into pathophysiology and treatment options are crucial as till date BD remains one the most disabling mental health disorder affecting every aspect of life; individual, social, economic, global. BD is the fifth leading cause among psychiatric disorders of lost years of work. (5) It is therefore imperative that a new treatment is established and further research is warranted in regards to Endoxifen for better understanding to develop safe treatment, not only for management but possible cure. Continuous...

scholarly journals Efficacy of probiotics in irritable bowel syndrome: A randomized, double blind placebo-controlled study

2016 ◽  
Vol 6 (1) ◽  
pp. 21 ◽  
Author(s):  
Md. Zahidur Rahman ◽  
Mohammad Shoaib Chowdhury ◽  
Mohammad Asadur Rahman ◽  
Shohely Parveen ◽  
Rajib Barua ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Placebo Group ◽  
Intestinal Microbiota ◽  
Therapeutic Potential ◽  
Intestinal Barrier ◽  
Controlled Study ◽  
Double Blind ◽  
Before And After ◽  
Irritable Bowel

<p><strong>Background:</strong> Gut flora have important trophic effects on intestinal epithelia and on immune structure and fonction.They also protect colonized host against invasion by alien microbes.Recent research suggests that an imbalance of the intestinal microbiota and a dysfunctional intestinal barrier might trigger irritable bowel syndrome (lBS). As probiotics have been reported to restore the intestinal microbiota and the gut barrier, the therapeutic potential of probiotics within IBS became of strong interest. <strong></strong></p><p><strong>Objectives: </strong>To assess the efficacy of probiotics in lBS. <strong></strong></p><p><strong>Methods: </strong>Patients of 15 to 60 years old and both sexes were included f om the out patient department (OPD) of gastroenterology, Bangabandhu Sheikh Mujib Medi­cal University (BSMMU). A validated lBS-QOL instmment consisted of 34 questions used to assess improvement of quality of Iife before and after treatment. A total of 65 diarrhoea predominant LBS patients were randomised to receive either probiotics(n-33) or placebo(n-32) twice daily frir 6 weeks.</p><p><strong>Results:</strong> At the end of 6 weeks therapy, improvement in various symptoms(abclominal pain, stool frequency, consistency and 11atulence) in probiotics group was statistically significant. Mean QOL score before treatment was 103 in probiotics group and I 06 in placebo group. After 6 weeks of treatment mean QOL score was 82 in probiotics group and I 02.58 in placebo group. No side effects of the therapeutic agents were observed in any patient during the trial. <strong></strong></p><p><strong>Conclusions:</strong> Probiotics effectively alleviates global IBS and improves TBS symptoms simultaneously with an improvement of quality of life.</p>

Acupuncture for Diagnostic Fiberoptic Bronchoscopy: A Prospective, Randomized, Placebo-Controlled Study

2006 ◽  
Vol 34 (03) ◽  
pp. 409-415 ◽  
Author(s):  
Luca Cabrini ◽  
Luigi Gioia ◽  
Marco Gemma ◽  
Giulio Melloni ◽  
Angelo Carretta ◽  
...  
Keyword(s):  
Fiberoptic Bronchoscopy ◽  
Sham Acupuncture ◽  
Controlled Study ◽  
Double Blind Study ◽  
Patient Anxiety ◽  
Double Blind ◽  
Before And After ◽  
Routine Basis ◽  
Group A ◽  
Group B

Patients usually fear fiberoptic bronchoscopy (FBS) and they report a low level of satisfaction after this examination. We evaluated the efficacy of acupuncture in decreasing patient anxiety before diagnostic FBS and in improving tolerance to the examination. In a prospective double-blind study, we enrolled 48 patients scheduled to undergo diagnostic FBS. Patients were randomly assigned to one of three groups. Group A (16 patients): standard FBS, with airway topic anesthesia; Group B (16 patients): standard FBS, with airway topic anesthesia and acupuncture treatment; Group C (16 patients): standard FBS, with airway topic anesthesia and sham acupuncture. EKG, non-invasive arterial pressure, and pulse oximetry were monitored on a routine basis. We evaluated patient anxiety before and after acupuncture and, at the end of FBS, the discomfort suffered during the examination by a 100-mm Visual Analog Scale (VAS). Patient satisfaction in Group A was 50% worse than in Group B ( p = 0.04). We observed a strong, even if not statistically significant, tendency toward a lower pre-FBS anxiety in Group B. Patients in group C had values very close to those recorded in group A. We observed no adverse event and no differences in cardio-respiratory parameters in these three groups; in particular, we did not observe a respiratory depression in Group B. Acupuncture seems an effective resource for a Thoracic Endoscopic Room to improve patient tolerance to FBS.

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