Glabellare Falten: Wie die Wirkung von Botulinumtoxin A verlängert werden kann

2021 ◽  
pp. 1-2
Author(s):  
Welf Prager
Keyword(s):  
Median Duration ◽  
Dose Group ◽  
Botulinum Toxin A ◽  
Statistical Significance ◽  
Dose Effect ◽  
Double Blind Study ◽  
Statistical Significance Testing ◽  
Double Blind ◽  
Duration Of Effect ◽  
Facial Wrinkle

<b>Background:</b> Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin®, Bocouture®; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here. <b>Methods:</b> 151 subjects with moderate-to-severe GFL were randomized 1:2:2 to receive a single treatment with 20U, 50U, or 75U INCO. The primary efficacy endpoint was median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale. <b>Results:</b> The median duration of effect was 185 days for the 50U dose group (95% CI: [182, 205]) and 210 days for the 75U dose group (95% CI: [182, 217]). Duration of effect was significantly longer for 75U vs 50U (P = 0.0400) and 20U (P = 0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups. Duration of effect was also longer for 50U vs 20U, however; statistical significance was not reached (P = 0.4349). The incidence of treatment-related adverse events was low across all doses (20U:2 [6.7%], 50U:6 [10.0%] and 75U:8 [13.1%]). <b>Conclusions:</b> These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated and safety was consistent with the known safety profile of 20U INCO for GFL. J Drugs Dermatol. 2020;19(10):985–991. doi:10.36849/JDD.2020.5454

scholarly journals EXPRESS: Efficacy and Safety of Tadalafil in a Pediatric Population with Pulmonary Arterial Hypertension: Phase 3 randomized, Double Blind Placebo-Controlled Study

2021 ◽  
pp. 204589402110249
Author(s):  
David D Ivy ◽  
Damien Bonnet ◽  
Rolf MF Berger ◽  
Gisela Meyer ◽  
Simin Baygani ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Statistical Significance ◽  
Significance Testing ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Statistical Significance Testing ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Groups ◽  
Pulmonary Arterial

Objective: This study evaluated the efficacy and safety of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH). Methods: This phase-3, international, randomized, multicenter (24 weeks double-blind placebo controlled period; 2-year, open-labelled extension period), add-on (patient’s current endothelin receptor antagonist therapy) study included pediatric patients aged <18 years with PAH. Patients received tadalafil 20 mg or 40 mg based on their weight (Heavy-weight: ≥40 kg; Middle-weight: ≥25—<40 kg) or placebo orally QD for 24 weeks. Primary endpoint was change from baseline in 6-minute walk (6MW) distance in patients aged ≥6 years at Week 24. Sample size was amended from 134 to ≥34 patients, due to serious recruitment challenges. Therefore, statistical significance testing was not performed between treatment groups. Results: Patient demographics and baseline characteristics (N=35; tadalafil=17; placebo=18) were comparable between treatment groups; median age was 14.2 years (6.2 to 17.9 years) and majority (71.4%, n=25) of patients were in HW cohort. Least square mean (SE) changes from baseline in 6MW distance at Week 24 was numerically greater with tadalafil versus placebo (60.48 [20.41] vs 36.60 [20.78] meters; placebo-adjusted mean difference [SD] 23.88 [29.11]). Safety of tadalafil treatment was as expected without any new safety concerns. During study period 1, two patients (1 in each group) discontinued due to investigator’s reported clinical worsening, and no deaths were reported. Conclusions: The statistical significance testing was not performed between the treatment groups due to low sample size, however, the study results show positive trend in improvement in non invasive measurements, commonly utilized by clinicians to evaluate the disease status for children with PAH. Safety of tadalafil treatment was as expected without any new safety signals.

A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

1997 ◽  
Vol 25 (4) ◽  
pp. 175-181 ◽  
Author(s):  
H Al-Muhaimeed
Keyword(s):  
Allergic Rhinitis ◽  
Statistical Significance ◽  
Double Blind Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Once Daily ◽  
Runny Nose ◽  
Parallel Group ◽  
The Mean ◽  
To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

Phase III, randomized, double-blind study of elesclomol and paclitaxel versus paclitaxel alone in stage IV metastatic melanoma (MM)

2009 ◽  
Vol 27 (18_suppl) ◽  
pp. LBA9012-LBA9012 ◽  
Author(s):  
A. Hauschild ◽  
A. M. Eggermont ◽  
E. Jacobson ◽  
S. J. O'Day
Keyword(s):  
Oxidative Stress ◽  
Statistical Significance ◽  
Stage Iv ◽  
Median Number ◽  
Phase Iii ◽  
Double Blind Study ◽  
Double Blind ◽  
Cytotoxic Treatment ◽  
Number Of Cycles ◽  
Induced Apoptosis

LBA9012 Background: Elesclomol is an investigational first-in-class oxidative stress inducer that increases oxidative stress in cancer cells leading to mitochondria-induced apoptosis. Methods: Patients (pts) with Stage IV MM, no prior chemotherapy, LDH μ 2× ULN were randomized (1:1) to either 213 mg/m2 elesclomol in combination with 80 mg/m2 paclitaxel (ELPAC) or 80 mg/m2 paclitaxel alone (P); both were given weekly ×3 followed by 1 week rest until disease progression. Pts were stratified by prior non-cytotoxic treatment, M1 grade, and LDH. The primary endpoint was PFS with >90% power to detect a 2-month improvement. The primary PFS analysis was planned once all pts had been enrolled and at least 164 PFS events had occurred. Results: 651 pts were enrolled between September 2007 and February 2009. Prognostic factors were generally well balanced. PFS analysis was based on investigator assessment of 411 pts (219 events). Median PFS was 3.5 m (95% CI 2.7–3.7) in ELPAC and 1.9 m (95% CI 1.9–3.3) in P [HR 0.88; 95% CI 0.67–1.16, p=0.3695]. The median number of cycles was 3 in ELPAC and 2 in P. Safety analysis showed increased signals on ELPAC including increased ≥Gr 3 AEs (N=405, 32.8% vs. 23.5%), increased AEs leading to death (N=405, 3.5% vs <1%) and increased overall deaths (N=651, 80 vs 53; 80% censored). Most common AEs in ELPAC were fatigue (32.8%), alopecia (31.3%) and nausea (27.9%). Conclusions: There was an improvement in PFS in the ELPAC arm, but it did not achieve statistical significance. In February 2009, the study was halted based on the recommendation of the DMC to unblind the study after the DMC observed increased deaths on the ELPAC arm. The DMC could not determine whether the observed increased deaths were treatment related or not. Of note, in this analysis there were no specific target organ toxicities attributable to ELPAC that could explain the imbalance of deaths. OS data continues to be collected to determine if the observed imbalance in OS persists as the data mature. [Table: see text]

Long-Term Effects of Haloperidol on Severely Emotionally Disturbed Children

1971 ◽  
Vol 5 (4) ◽  
pp. 296-300 ◽  
Author(s):  
G. H. Wong ◽  
R. J. Cock
Keyword(s):  
Emotional Disorders ◽  
Emotionally Disturbed ◽  
Statistical Significance ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Double Blind ◽  
Diagnostic Categories ◽  
Learning Tasks ◽  
Severely Emotionally Disturbed

A controlled, double-blind study of haloperidol in 30 children suffering from severe emotional disorders was attempted. Toxic and side-effects and reduction of symptoms were observed over a prolonged period of medication. A battery of tests was designed to study any adverse effects on development and learning processes. The conclusions reached indicated that at an overall level and in terms of diagnostic categories, no statistical significance was established when compared with placebo. However, haloperidol is significantly superior to placebo in ameliorating particular symptoms, is a relatively safe drug, and it did not impair intellectual functioning and learning tasks.

Distant effects of locally injected botulinum toxin: A double-blind study of single fiber EMG changes

1991 ◽  
Vol 14 (7) ◽  
pp. 672-675 ◽  
Author(s):  
Dale J. Lange ◽  
Michael Rubin ◽  
Paul E. Greene ◽  
Un J. Kang ◽  
Carol B. Moskowitz ◽  
...  
Keyword(s):  
Botulinum Toxin ◽  
Botulinum Toxin A ◽  
Blind Study ◽  
Single Fiber ◽  
Double Blind Study ◽  
Toxin A ◽  
Double Blind

scholarly journals One-Abutment One-Time Effect on Peri-Implant Marginal Bone: A Prospective, Controlled, Randomized, Double-Blind Study

Materials ◽  
2021 ◽  
Vol 14 (15) ◽  
pp. 4179
Author(s):  
Filipe Moreira ◽  
Salomão Rocha ◽  
Francisco Caramelo ◽  
João P. Tondela
Keyword(s):  
Bone Loss ◽  
Statistical Significance ◽  
Test Group ◽  
Primary Stability ◽  
Control Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Implant Placement ◽  
Bone Level ◽  
The Mean

Objective: To evaluate the peri-implant hard tissue change at 6 and 12 months after implant placement between definitive abutment placed at the same time of implant surgery, never removing it, and healing abutment disconnected and reconnected three times until the placement of the final rehabilitation. Material and methods: Each partial edentulous patient could receive between 1 and 4 platform-switched implants in the posterior regions. If the implants had primary stability—implant stability quotient (ISQ) equal to or greater than 50, they were randomized to the test group with the abutment inserted at the same time of implant placement (DA) or to the control group, receiving a healing abutment (PA). At 6 and 12 months after surgery, data related with vertical bone level changes (primary outcome) and other clinical parameters (implant mobility, bleeding on probing, probing depth, plaque index) were assessed. Results: 53 implants were included in the trial and completed 12 months follow-up (overall survival rate: 100%). All implants achieved primary stability, with an average ISQ value of 80.9 on the day of surgery. From surgery to 6 months, the mean bone loss was 0.14 ± 0.18 mm for the DA group and 0.23 ± 0.29 mm for the PA group, without statistical significance difference. Between 6 and 12 months, the mean bone loss was 0.14 ± 0.21 mm for the DA group and 0.21 ± 0.27 mm for the PA group, also without statistical significance between the two groups. There were no statistically significant differences (p = 0.330) in total bone loss after 12 months between the control and the study groups. Conclusions: The one abutment one time protocol has at least an equivalent effect on the peri-implant bone level changes when compared with the use of healing abutments that are disconnected and reconnected at least three times.

OCT as a monitoring tool for assessment of the stage and severity of multiple sclerosis

2020 ◽  
Vol 1 (3) ◽  
pp. 179-182
Author(s):  
Yoav Yechezkel Pikkel ◽  
◽  
Vadim Igal ◽  
Yael Sara Pikkel Igal ◽  
Adi Nov-Sharabi ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Statistical Significance ◽  
Control Group ◽  
Double Blind Study ◽  
Monitoring Tool ◽  
Fiber Layer ◽  
Double Blind ◽  
Rnfl Thickness ◽  
Disability Status ◽  
The Mean

AIM: To identify a link between optical coherence tomography (OCT), length of multiple sclerosis (MS) and the expanded disability status scale (EDSS). METHODS: In a prospective double blind study, 29 patients with a diagnosis of MS were compared with 29 healthy patients, matched by age and sex. All participants underwent an OCT study and neurological EDSS test on the same day. RESULTS: The mean EDSS score was 3.2 in the MS group vs 0.03 in the control group, and the duration of MS is 11.7y. The mean retinal nerve fiber layer (RNFL) thickness was significantly thinner in those with MS (P<0.001). Correlation was found between duration of MS and RNFL thinning. EDSS and thinning of RNFL showed a tendency to correlate but without statistical significance.

Treatment of spasticity with botulinum toxin: A double-blind study

1990 ◽  
Vol 28 (4) ◽  
pp. 512-515 ◽  
Author(s):  
Barry J. Snow ◽  
Joseph K. C. Tsui ◽  
Mohit H. Bhatt ◽  
Michael Varelas ◽  
Stanley A. Hashimoto ◽  
...  
Keyword(s):  
Botulinum Toxin ◽  
Botulinum Toxin A ◽  
Blind Study ◽  
Double Blind Study ◽  
Toxin A ◽  
Double Blind

The Effects of Vitamin-Mineral Supplements on Serious Rule Violations in Correctional Facilities for Young Adult Male Inmates: A Randomized Controlled Trial

2021 ◽  
pp. 001112872198907
Author(s):  
Stephen Schoenthaler ◽  
David Gast ◽  
Erik J. Giltay ◽  
Stephen Amos
Keyword(s):  
Young Adult ◽  
Adult Male ◽  
Dose Group ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Double Blind ◽  
Mineral Supplements ◽  
Randomized Controlled ◽  
Young Adult Male ◽  
Male Inmates

We investigated whether vitamin-mineral supplementation could reduce serious rule violations. In this randomized, controlled, double-blind trial, young adult male inmates were included. For 15 weeks, they received a daily dose with vitamin-mineral supplements of approximately 100% Recommended Dietary Allowance (RDA) ( n = 149), or a higher-dose formula ( n = 150), or placebo ( n = 150). Serious rule violations were the primary outcome. In the lower-dose group there were 39% fewer rule violations than in the placebo group (relative risk = .61; 95% confidence interval [ CI]:.41–.90, p = .01). In the higher-dose group the difference did not reach statistical significance. About 100% RDA, but not higher doses supplements, resulted in less serious rule violations than placebo.

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