scholarly journals Non‐invasive clinical and microscopic evaluation of the response to treatment with clobetasol cream vs. calcipotriol/betamethasone dipropionate foam in mild to moderate plaque psoriasis: an investigator‐initiated, phase IV, unicentric, open, randomized clinical trial

2020 ◽  
Author(s):  
O. Yélamos ◽  
B. Alejo ◽  
S. S. Ertekin ◽  
L. Villa‐Crespo ◽  
S. Zamora‐Barquero ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Plaque Psoriasis ◽  
Betamethasone Dipropionate ◽  
Response To Treatment ◽  
Non Invasive ◽  
Microscopic Evaluation ◽  
Calcipotriol Betamethasone ◽  
Phase Iv

scholarly journals Evaluation of the Effect of Platelet Mediators to Increase the Skin's Collagen; A Randomized Clinical Trial

2017 ◽  
Vol 9 (9) ◽  
pp. 52
Author(s):  
Hamidollah Afarsiabian ◽  
Mitra Nourbakhsh ◽  
Majid Sadeghizadeh
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Platelet Rich Plasma ◽  
Response To Treatment ◽  
Ultrasound Images ◽  
Facial Skin ◽  
Non Invasive ◽  
Skin Collagen ◽  
Group A ◽  
Group B

OBJECTIVE: The aim of this paper is to evaluate the effect of platelet-rich plasma mediators on the reconstruction of facial skin collagen by a platelet cream. Additionally, the cream was composited with plasma and some herbal compounds, which carried those factors through the skin. This method as a non-invasive skin will help the skin rejuvenation.MATERIALS & METHODS: This study is a randomized clinical trial; patients referred to the clinic with positive cases from skin wrinkles along with 20 MHz frequency ultrasound images of their skin faces. All individual enrolled in the study were randomly divided into two groups.Group A 70cc cream including 60cc basic cream (emulsion of Lecithin and Eucerin) in addition of 5cc platelet-rich plasma and 5ccherbal extracted (Herdahelix, Musk and Genestein) to take a month received. Consequently, instructions for use of this cream is that 2.3g of the cream every night to be affected.Group B (controls) received 70cc of the cream involving 6cc basic cream (emulsion of Lecithin and Eucerin) along with 10cc placebo (glycerin) that every night 2.3g of the cream to be applied on the face.After a month increased the amount of facial skin collagen in each group was calculated and compared by ultrasound 20 MHz. In this project compare numerically and in terms of the amount of reflected energy (RE) was performed. In addition, the idea of using plant extracts and platelet mediators to penetrate into the skin was derived from Iranian traditional medicine.FINDINGS: Statistical analysis of the data collection was done by SPSS 18 software. Further, demographic characteristics including age, sex, occupation, socioeconomic status and education level had no effect on the response to treatment (P=0.221), but demographic indicator of age on response to treatment was effective (P=0.021).Respond to the treatment (increase the amount of collagen in the skin) in group A and group B equal to 72.91%   and 12.5% respectively. In group A with group B were significant differences in response to treatment, P = 0.000. The only side effect occurred in group A was mild irritation including redness and mild itching, which happened in 2 patients.CONCLUSION: Employee non-invasive method of platelet cream rebuilds collagen in the skin effectively.

scholarly journals A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Christine Elizabeth Jones ◽  
Anna Calvert ◽  
Jo Southern ◽  
Mary Matheson ◽  
Nick Andrews ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Pertussis Toxin ◽  
Geometric Mean ◽  
Control Group ◽  
Primary Immunization ◽  
Link Type ◽  
In Pregnancy ◽  
Pertussis Antigens ◽  
Phase Iv

Abstract Background Pertussis vaccines containing three or five pertussis antigens are recommended in pregnancy in many countries, but no studies have compared the effect on infants’ antigen-specific immunoglobulin G (IgG) concentrations. The aim of this study was to compare anti-pertussis IgG responses following primary immunization in infants of mothers vaccinated with TdaP5-IPV (low dose diphtheria toxoid, tetanus toxoid, acellular pertussis [five antigens] and inactivated polio) or TdaP3-IPV in pregnancy (three pertussis antigens). Methods This multi-centre phase IV randomized clinical trial was conducted in a tertiary referral centre and primary care sites in England. Women were randomized to receive TdaP5-IPV (n = 77) or TdaP3-IPV (n = 77) at 28–32 gestational weeks. A non-randomized control group of 44 women who had not received a pertussis-containing vaccine in pregnancy and their 47 infants were enrolled post-partum. Results Following infant primary immunization, there was no difference in the geometric mean concentrations (GMCs) of anti-pertussis toxin, filamentous haemagglutinin or pertactin IgG between infants born to women vaccinated with TdaP5-IPV (n = 67) or TdaP3-IPV (n = 63). However, the GMC of anti-pertussis toxin IgG was lower in infants born to TdaP5-IPV- and TdaP3-IPV-vaccinated mothers compared to infants born to unvaccinated mothers (n = 45) (geometric mean ratio 0.71 [0.56–0.90] and 0.78 [0.61–0.98], respectively); by 13 months of age, this difference was no longer observed. Conclusion Blunting of anti-pertussis toxin IgG response following primary immunization occurs in infants born to women vaccinated with TdaP5-IPV and TdaP3-IPV, with no difference between maternal vaccines. The blunting effect had resolved by 13 months of age. These results may be helpful for countries considering which pertussis-containing vaccine to recommend for use in pregnancy. Trial registration ClinicalTrials.gov, NCT02145624, registered 23 May 2014

scholarly journals NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne van der Meij ◽  
Marianne A. A. van Walderveen ◽  
Nyika D. Kruyt ◽  
Erik W. van Zwet ◽  
Eric J. Liebler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Vagus Nerve ◽  
Randomized Clinical Trial ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Standard Treatment ◽  
Infarct Volume ◽  
Non Invasive ◽  
Link Type

Abstract Background Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulation (VNS) inhibits these detrimental changes and thereby reduces tissue injury. The aim of this study is to investigate whether non-invasive cervical VNS (nVNS) in addition to the current standard treatment can improve penumbral recovery and limit final infarct volume. Methods NOVIS is a single-center prospective randomized clinical trial with blinded outcome assessment. One hundred fifty patients will be randomly allocated (1:1) within 12 h from clinical stroke onset to nVNS for 5 days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day 5 assessed with MRI. Discussion We hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery. The results of this study will be used to assess the viability and approach to power a larger trial to more definitively assess the clinical efficacy of nVNS after stroke. Trial registration ClinicalTrials.govNCT04050501. Registered on 8 August 2019

Efficacy of Calcipotriol-Betamethasone Ointment in Patients with Mild to Moderate Plaque Psoriasis: Subgroup Analyses

Dermatology ◽  
2019 ◽  
Vol 235 (6) ◽  
pp. 501-508 ◽  
Author(s):  
Nina Habjanič ◽  
Vesna Lužar-Stiffler ◽  
Mojca Kerec-Kos ◽  
Darja Grabnar Peklar
Keyword(s):  
Plaque Psoriasis ◽  
Treatment Effectiveness ◽  
Late Onset ◽  
Univariate Analysis ◽  
Severity Index ◽  
Normal Weight ◽  
Response To Treatment ◽  
Using Data ◽  
The Impact ◽  
Calcipotriol Betamethasone

Background: Several factors have been shown to affect psoriasis pathogenesis, clinical presentation and treatment response. Objectives: The aim of this study was to investigate the potential relationship between patients’ baseline characteristics and the efficacy of calcipotriol-betamethasone ointment in patients with mild to moderate plaque psoriasis and to evaluate whether the efficacy is consistent across subgroups. Method: Using data from the therapeutic equivalence study on patients with plaque psoriasis, post hoc analyses were performed to evaluate the impact of baseline demographic and disease characteristics, habits and comorbidities on the response to treatment with calcipotriol-betamethasone ointment. Results: Body mass index (BMI) and obesity were each independently associated (univariate analysis, p < 0.05) with reduction in modified Psoriasis Area and Severity Index (mPASI) and PASI75 (≥75% improvement in mPASI from baseline). Increased body weight is more common in patients with late-onset psoriasis. There was a significant trend for lower response rates with increasing BMI (p = 0.007) and obesity (p = 0.003). The odds of achieving PASI75 is 2.3 times lower for obese compared to normal-weight subjects.If patients with obesity or hypertension were treated with calcipotriol-betamethasone, they were still more likely to achieve PASI75 after 4-week treatment compared to vehicle (p < 0.001). Conclusion: Increased BMI and obesity present risk factors for reduced treatment effectiveness. Importantly, the efficacy of calcipotriol-betamethasone ointment was consistent in all subgroups.

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