scholarly journals A randomized, double-blind, comparative study for efficacy assessment of two hyaluronic acid nasolabial fillers

2018 ◽  
Vol 3 (2) ◽  
Author(s):  
Saman Ahmad Nasrollahi ◽  
Mansour Nassiri Kashani ◽  
Taraneh Yazdanparast ◽  
Setareh Ameri ◽  
Alireza Firooz
Keyword(s):  
Hyaluronic Acid ◽  
Safety Assessment ◽  
Clinical Signs ◽  
P Value ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Efficacy Assessment ◽  
Spss Software ◽  
Nasolabial Folds ◽  
Better Than

<p class="Default">Hyaluronic acid fillers are considered safe for use in cosmetics as described in the safety assessment. This study was aimed to assess and compare the efficacy and safety of two hyaluronic acid (HA) fillers on mild nasolabial folds. Ten women aged 30-50 years with mild nasolabial folds participated for injection of A and B gels into right or left nasolabial folds. The volume and surface of nasolabial folds were measured by CSI software and the density and thickness of dermis assessed by skin ultrasonography before and 2, 12, and 24 weeks after injection. The data were analyzed using SPSS software version 20, and p-value &lt;0.05 were considered as significant. Global assessment showed over 50% improvement in patients injected with both gel A and B. At 2 weeks after injecting gel A the volume and surface of wrinkles decreased significantly. In the side injected with gel B, this reduction was significant at 2 and 12 weeks after injection. In addition, 24 weeks after injection of both gels the dermis echo-density increased and the dermis thickness decreased.  This study indicated the significant positive filling effect of both HA fillers in decreasing the clinical signs of wrinkles at nasolabial folds. Comparing both fillers, there were not any statistically significant differences in any of measurements, but the persistence of gel B to improve the wrinkle appearance was slightly better than gel A. </p>

Almotriptan is an Effective and Well-Tolerated Treatment for Migraine Pain: Results of A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Cephalalgia ◽  
2002 ◽  
Vol 22 (6) ◽  
pp. 453-461 ◽  
Author(s):  
AJ Dowson ◽  
H Massiou ◽  
JM Laínez ◽  
X Cabarrocas
Keyword(s):  
Adverse Events ◽  
Standard Treatment ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Migraine Pain ◽  
Significant Difference ◽  
Severe Intensity ◽  
Efficacy Assessment ◽  
Better Than

Almotriptan is a novel and specific serotonin 5-HT1B/1D agonist for the acute treatment of migraine. This randomized, single-dose, double-blind, multicentre, study assessed the efficacy and safety of oral almotriptan (12.5 mg and 25 mg) in patients with migraine, and compared it with the standard treatment (sumatriptan 100 mg) and placebo. A total of 668 patients treated one migraine attack of moderate or severe intensity with study medication. The primary efficacy assessment was migraine pain relief, improvement from severe or moderate pain to mild or no pain, at 2 h after treatment. Response rates, stratified for variation in baseline pain levels, for both almotriptan doses were equivalent to sumatriptan and significantly better than placebo. Other efficacy assessments confirmed the equivalence of the almotriptan groups with the sumatriptan group. Almotriptan 12.5 mg was as well tolerated as placebo ( P = 0.493) and significantly better tolerated than sumatriptan ( P < 0.001), in terms of the overall incidence of adverse events. There was no statistically significant difference in the incidence of adverse events between almotriptan 25 mg and sumatriptan 100 mg ( P = 0.376). The results from this large clinical study indicate that the new, specific 5-HT1B/1D agonist, almotriptan, is an effective and well-tolerated treatment for migraine pain.

scholarly journals POS0928 NETAKIMAB EFFICACY IN ANTI-TNF-NAIVE AND ANTI-TNF-EXPERIENCED PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS OF SUBANALYSIS OF PHASE 3 ASTERA TRIAL

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 726.2-727
Author(s):  
S. Erdes ◽  
V. Mazurov ◽  
T. Dubinina ◽  
I. Gaydukova ◽  
A. Kundzer ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Phase Iii ◽  
P Value ◽  
Interleukin 17 ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Two Phase ◽  
Double Blind ◽  
Asas Criteria

Background:According to previous studies, the effectiveness of interleukin-17 (IL-17) inhibitors was higher in anti-TNF-naïve patients with ankylosing spondylitis (AS) [1,2]. Netakimab (NTK) is a humanized anti-IL-17A antibody approved for the treatment of AS, psoriatic arthritis, moderate-to-severe plaque psoriasis in Russia and Belarus.Objectives:To compare the efficacy of NTK in anti-TNF-naïve patients with anti-TNF-experienced patients with active AS at week 16 of therapy.Methods:ASTERA (NCT03447704) is an ongoing phase 3 placebo (PBO)-controlled clinical study, aimed at evaluating NTK efficacy in AS [3]. 228 adult patients with active AS (BASDAI ≥ 4) were randomly assigned (1:1) to receive 120 mg NTK or PBO subcutaneously at week 0,1,2 and then q2w. This analysis includes 112 patients in NTK group. Efficacy endpoints included ASAS20/40, ASAS5/6 and ASAS partial remission (PR) at week 16 of therapy.Results:28 (25.0%) of 112 patients in NTK group had previous inadequate response/intolerance to anti-TNF (anti-TNF-IR): 24 (21.4%) – one anti-TNF, and 4 (3.6%) – two anti-TNF. 84 (75.0%) patients were TNF-naive. Achievement of ASAS criteria response at week 16 was similar in both groups (Table 1).Table 1.Efficacy of NTK at week 16ParameterTNF-naïve (n = 84)anti-TNF-IR (n = 28)p-value*ASAS20, n (%)52 (61.9%)17 (60.7%)0.91ASAS40, n (%)35 (41.7%)11 (39.3%)0.82ASAS5/6, n (%)39 (46.4%)11 (39.3%)0.51ASAS(PR), n (%)15 (17.9%) 4 (14.3%)0.78*- Fisher’s exact testConclusion:NTK 120 mg provided sustained improvements in signs and symptoms of AS in anti-TNF-naive and anti-TNF-IR patients at 16 weeks of therapy.References:[1]Blair HA, Dhillon S. Secukinumab: A Review in Ankylosing Spondylitis. Drugs. 2016;76(10):1023-30.[2]Dougados M, et al. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020;79(2):176-185.[3]Mazurov VI, et al. Efficacy and safety of Netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA. Nauchno-Practicheskaya Revmatologia=Rheumatology Science and Practice. 2020;58 (4):376–386 (In Russ).Acknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Shandor Erdes: None declared, V Mazurov: None declared, Tatiana Dubinina: None declared, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Anna Eremeeva Employee of: Biocad

A Clinical Comparison of Triazolam with Placebo and with Secobarbital in Insomniac Patients

1978 ◽  
Vol 6 (4) ◽  
pp. 343-347 ◽  
Author(s):  
K Kay Okawa ◽  
George S Allen
Keyword(s):  
Side Effects ◽  
Sleep Duration ◽  
Sleep Onset ◽  
Questionnaire Data ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Sleep Questionnaire ◽  
Clinical Comparison ◽  
Hypnotic Efficacy ◽  
Better Than

Seventy-six out-patient insomniacs participated in three different two-night, double-blind crossover trials investigating the hypnotic efficacy and safety of triazolam. Triazolam 0.5 mg was compared to placebo in one trial conducted by K Kay Okawa, MD, and triazolam 0.5 mg was compared to secobarbital 100 mg in trials conducted by K Kay Okawa, MD and George S Allen, MD. The results of the latter two studies were combined and the data analyzed jointly. Triazolam 0.5 mg was found to be preferred and to be significantly better than both placebo and secobarbital 100 mg in the treatment of insomnia. Analysis of sleep questionnaire data showed triazolam to be superior to either placebo or secobarbital on the following parameters: how much the medication helped the patient sleep; onset of sleep; duration of sleep; and number of nocturnal awakenings. No differences were observed between treatments in any trial with regard to the patient's feeling of alertness the next morning. The side-effects reported for all treatments did not significantly interfere with the patients' ability to function.

The Efficacy and Safety of Lidocaine-Containing Hyaluronic Acid Dermal Filler for Treatment of Nasolabial Folds: A Multicenter, Randomized Clinical Study

2015 ◽  
Vol 39 (6) ◽  
pp. 953-962 ◽  
Author(s):  
Won Joon Choi ◽  
Seung Won Han ◽  
Jung Eun Kim ◽  
Hye Won Kim ◽  
Moon Beom Kim ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Clinical Study ◽  
Dermal Filler ◽  
Efficacy And Safety ◽  
Randomized Clinical Study ◽  
Nasolabial Folds

A Multicenter, Randomized, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of PP-501-B in Correction of Nasolabial Folds

2015 ◽  
Vol 41 (1) ◽  
pp. 113-120 ◽  
Author(s):  
Kui Young Park ◽  
Eun Jung Ko ◽  
Beom Joon Kim ◽  
Myeung Nam Kim ◽  
Chang Kwun Hong ◽  
...  
Keyword(s):  
Clinical Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Nasolabial Folds

Efficacy and Safety of a Combination of Cinnarizine and Dimenhydrinate in the Treatment of Vertigo

2018 ◽  
Vol 3 (01) ◽  
Author(s):  
Dr. Mayuresh Kiran ◽  
Mr. Lalit Pawaskar
Keyword(s):  
Clinical Study ◽  
Adverse Events ◽  
Calcium Antagonists ◽  
Safety Assessment ◽  
Channel Blocker ◽  
Medical Condition ◽  
Age Group ◽  
Efficacy And Safety ◽  
Efficacy Assessment ◽  
Antihistaminic Drug

Introduction and Background: Vertigo is a medical condition where a person feels as he/ she or the objects around them are moving when they are stable and not moving. Antihistamines, Calcium antagonists, histamine analogs (eg, betahistine derivatives), diuretics, neuroleptics as well as other psychotherapeutic drugs, corticosteroids agents and hemorheologics can be used for the treatment of Vertigo. Combination of Cinnarizine which is a selective calcium-channel blocker and Dimenhydrinate which is an H 1 antihistaminic drug can be used in combination for the treatment of vertigo. This clinical study was conducted to evaluate the efficacy and safety of combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg in patients of vertigo of age group 18 to 65 years. Methodology: Out of total 216 patients, 168 completed the study. Efficacy assessment was made by analysing the reduction in vertigo symptom score (VSS). Safety assessment was made by analysing the adverse events experienced by the patient or observed by the investigator during trial. Results: Reduction in VSS from 7.277 (baseline) to 3.975 (day 3) and 0.987 (day 5). At visit 2 and visit 3 there was reduction of 45.373 % and 86.426 % in mean VSS score. Conclusion: A combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg is safe and efficacious in the treatment of vertigo.

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