Sample sizes for phase II and phase III clinical trials: An integrated approach

1986 ◽  
Vol 5 (5) ◽  
pp. 459-464 ◽  
Author(s):  
John Whitehead
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Integrated Approach ◽  
Phase Iii ◽  
Sample Sizes ◽  
Phase Iii Clinical Trials

PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines

2020 ◽  
pp. 106002802094352
Author(s):  
Mary B. Gadarowski ◽  
Rima I. Ghamrawi ◽  
Sarah L. Taylor ◽  
Steven R. Feldman
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Data Extraction ◽  
Botulinum Toxin Type A ◽  
Botulinum Toxin Type ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Study Selection ◽  
Pubmed Database ◽  
Phase Ii And Iii

Objective: PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug. Data sources: A systematic literature review was performed using the terms “glabellar lines AND prabotulinumtoxinA” in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies. Study Selection and Data Extraction: Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( P < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; P < 0.001). PrabotulinumtoxinA was well tolerated across all studies. Relevance to Patient Care and Clinical Practice: This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians. Conclusion: PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis

2019 ◽  
Vol 54 (4) ◽  
pp. 380-387 ◽  
Author(s):  
Wendy Li ◽  
Rima Ghamrawi ◽  
Wasim Haidari ◽  
Steven R. Feldman
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Plaque Psoriasis ◽  
Data Extraction ◽  
Severity Index ◽  
Phase Iii ◽  
Cochrane Library ◽  
Severe Plaque Psoriasis ◽  
Phase Iii Clinical Trials ◽  
Interleukin 23

Objective: Risankizumab (Skyrizi), an interleukin-23 (IL-23) antagonist, was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in April 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this drug. Data Sources: A systematic literature review was performed using the terms “psoriasis AND risankizumab” in the OVID MEDLINE, PubMed, Cochrane Library, EMBASE, and Web of Science databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Extraction: Articles written in English between January 2000 and October 2019 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary end point at week 16 in phase III trials, more patients achieved Psoriasis Area and Severity Index 90 receiving 150 mg risankizumab (72%-75%) compared with placebo (2.0%-4.9%, P < 0.001), 45 or 90 mg ustekinumab (42.0%-48%, P < 0.0001), and 40 mg adalimumab (47%, P < 0.0001). More patients achieved a static Physician’s Global Assessment score of 0 or 1 receiving 150 mg risankizumab (84%-88%) compared with placebo (5.1%-7.8%, P < 0.001), 45 or 90 mg ustekinumab (62%-63%, P < 0.0001), and 40 mg adalimumab (60%, P < 0.0001). Risankizumab was well tolerated across all studies. Conclusion: Risankizumab is a newly FDA-approved IL-23 inhibitor that shows particular promise in the treatment of plaque psoriasis. Based on this review, it is an effective and safe addition to the armamentarium of biologics that are currently available.

scholarly journals Imposing Phase II and Phase III Clinical Trials of Targeted Drugs for Glioblastoma: Current Status and Progress

2021 ◽  
Vol 11 ◽  
Author(s):  
Yaning Wang ◽  
Wanqi Chen ◽  
Yixin Shi ◽  
Chengrui Yan ◽  
Ziren Kong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Phase Iii ◽  
Current Status ◽  
Future Research ◽  
Targeted Drugs ◽  
Comprehensive Overview ◽  
Phase Iii Clinical Trials ◽  
Degree Of Malignancy ◽  
Primary Intracranial Tumor

The most common primary intracranial tumor is glioma, among which glioblastoma (GBM) has the worst prognosis. Because of the high degree of malignancy of GBM and frequent recurrence after surgery, postoperative therapy, including chemotherapy, radiotherapy, targeted therapy, and immunotherapy, is particularly important. A wide variety of targeted drugs have undergone phase III clinical trials for patients with GBM, but these drugs do not work for all patients, and few patients in these trials have prolonged overall survival. In this review, some imposing phase III clinical trials of targeted drugs for glioma are introduced, and some prospective phase II clinical trials that have been completed or are in progress are summarized. In addition, the mechanisms of these drugs are briefly introduced, and deficiencies of these clinical trials are analyzed. This review aims to provide a comprehensive overview of current research on targeted drugs for glioma to clarify future research directions.

Hydrogen Peroxide 40% for the Treatment of Seborrheic Keratoses

2020 ◽  
Vol 55 (2) ◽  
pp. 216-221
Author(s):  
Colton H. Funkhouser ◽  
Kathleen M. Coerdt ◽  
Wasim Haidari ◽  
Michael A. Cardis
Keyword(s):  
Hydrogen Peroxide ◽  
Clinical Trials ◽  
Phase Ii ◽  
Treatment Options ◽  
Phase Iii ◽  
Treatment Modalities ◽  
Cochrane Library ◽  
Seborrheic Keratosis ◽  
Safe Alternative ◽  
Phase Iii Clinical Trials

Objective: Hydrogen peroxide 40% (HP40) was approved by the US Food and Drug Administration for topical treatment of seborrheic keratosis (SK) in December 2017. This article will review phase II and III clinical trials to assess the drug’s efficacy, safety, and clinical application. Data Sources: A systematic literature review was performed using the terms “Eskata AND seborrheic keratosis,” and “hydrogen peroxide AND seborrheic keratosis” in the OVID MEDLINE, PubMed, Cochrane Library, EMBASE, and Web of Science databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Abstraction: Articles written in English between January 2000 and mid-June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: In 2 phase III clinical trials, 4% and 8% of patients treated with HP40 had a Physician Lesion Assessment score of zero for all 4 SKs, respectively, compared with 0% in both vehicle groups at the primary end point of day 106 ( P < 0.01; P < 0.0001). Relevance to Patient Care and Clinical Practice: HP40, although less effective, has a better safety profile than other treatment options. It should be especially considered for treatment of facial SKs, where it is most efficacious and where other treatment modalities, such as cryotherapy, are more challenging. Conclusions: HP40 is a new, safe alternative treatment for SKs, although it is expensive and only modestly effective, both of which somewhat limit its overall utility. HP40 is a promising topical alternative, particularly for cosmetically sensitive locations, such as the face.

Sign in / Sign up

Export Citation Format

Share Document