Abstract:
BACKGROUND:Cutaneous warts are caused by human papilloma virus (HPV) infection. FIT039, a specific inhibitor of CDK9, suppresses the proliferation of DNA viruses in vitro. PURPOSE:We evaluated the safety, plasma concentrations, and efficacy of FIT039 delivered by single application of an adhesive skin patch on normal back skin and cutaneous warts. PATIENTS AND METHODS:In this placebo-controlled, dose-escalation, open-label, two-cohort phase I/II clinical trial, after a single administration of a 1% FIT039 patch, 3% FIT039 patch, or placebo on back skin, patients with cutaneous warts were treated with cryotherapy followed by a 1% FIT039 patch for 24 h in the first cohort. In the second cohort, cutaneous warts were treated with cryotherapy followed by a 3% FIT039 patch for 24 h. Adverse events and adverse drug reactions, the concentrations of FIT039, and surface area of cutaneous warts were evaluated. RESULTS:Neither irritant reactions nor symptoms related to FIT039 occurred when the FIT039 patches were applied to patients' backs or on warts in ten patients. The concentrations of FIT039 were under 0.1 ng/ml at every time point. The median wart surface area at 1 week after application of the 1% FIT039 patch was similar to baseline, while that of the 3% FIT039 patch was smaller than baseline. CONCLUSION:The FIT039 patch showed no topical or systemic adverse reactions when applied on normal skin or cutaneous warts. The safety and good adherence of the FIT039 patch are encouraging and support further studies to evaluate the efficacy of FIT039 in patients with cutaneous warts.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Sumi E,Nomura T,Asada R,Uozumi R,Tada H,Amino Y,Sawada T,Yonezawa A,Hagiwara M,Kabashima Kdoi
10.1007/s40261-018-0712-7subject
Has Abstractpub_date
2019-01-01 00:00:00pages
55-61issue
1eissn
1173-2563issn
1179-1918pii
10.1007/s40261-018-0712-7journal_volume
39pub_type
杂志文章abstract:OBJECTIVE:To evaluate the cost effectiveness of subcutaneous interferon-beta-1a (IFNbeta-1a) 44mug three times weekly in relapsing-remitting multiple sclerosis (RRMS) using an econometric model. METHODS:Data on RRMS patients treated with IFNbeta-1a 22 or 44mug subcutaneously three times weekly or placebo for up to 4 y...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323090-00003
更新日期:2003-01-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to confirm randomized clinical trial results showing that a fixed timolol/travoprost combination (TT; DuoTrav) controls intraocular pressure (IOP) better than a fixed timolol/latanoprost combination (TL; Xalacom) in everyday ophthalmic practice, when measured in the morning and >24 h...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/0044011-200828120-00004
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The optimal choice for first- and second-line antiseizure medications for pediatric patients with convulsive status epilepticus remains ambiguous. The present study aimed to estimate the comparative effect on the efficacy and safety of different antiseizure medications in pediatric patients wit...
journal_title:Clinical drug investigation
pub_type:
doi:10.1007/s40261-020-00975-7
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Dyslipidaemia is a major cardiovascular risk factor associated with type 2 diabetes mellitus. Saroglitazar (ZYH1) is a novel peroxisome proliferator-activated receptor (PPAR) agonist with predominant PPARα and moderate PPARγ activity. It has been developed for the treatment of dyslipidaemia an...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0128-3
更新日期:2013-11-01 00:00:00
abstract::Androgenetic alopecia (AGA) is characterized by non-scarring follicle miniaturization. Despite the success of approved therapies, commonly reported side effects and the need for continual use has led to the investigation of alternative therapies. The aim of this paper is to critically review the success of off-label, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-018-00743-8
更新日期:2019-03-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to evaluate the long-term cost effectiveness of exenatide once weekly (ExQW) versus insulin glargine (IG) or liraglutide 1.2 mg (Lira1.2mg) for the treatment of adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on oral antidiabetic drug (OAD) therapy...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-017-0586-0
更新日期:2018-01-01 00:00:00
abstract:BACKGROUND:Aliskiren is the first oral direct renin inhibitor to be approved for the treatment of hypertension. The pharmacokinetic and pharmacodynamic profile of aliskiren has been extensively characterized in Caucasian individuals; however, drug disposition, treatment response and tolerability can vary among ethnic g...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11533050-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The degree of cycle control achieved with a hormonal contraceptive method is an important determinant of its acceptance and continuation. This study set out to compare the cycle control and bleeding profile of drospirenone (DRSP) 3 mg/ethinylestradiol (EE) 20 μg in a 24-active pill/4-inert pill...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,meta分析,多中心研究
doi:10.2165/11590260-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. The objective of this study was to evaluate the safety and tolerability of the brand-to-generic levetiracetam switch in patients with focal or generalized epilepsy. METHODS:A prosp...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0351-1
更新日期:2016-01-01 00:00:00
abstract::We report the long-term effects of deferasirox 10-30 mg/kg/day on cardiac iron overload in a case series of five patients with transfusion-dependent beta-thalassaemia major who underwent up to 5 years of chelation therapy. Iron overload was monitored by multislice multi-echo T2* magnetic resonance imaging (MRI). Overa...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11534480-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Characteristics of nucleoside reverse transcriptase inhibitors (NRTIs) make the drug class susceptible to elimination via continuous veno-venous hemofiltration (CVVH), potentially leading to suboptimal drug concentrations if given at the recommended anephric doses during CVVH. The objective of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0275-9
更新日期:2015-04-01 00:00:00
abstract::The Editor-in-Chief has retracted this article because two of the three studies [1, 2] included in the meta-analysis (cited as references 11 and 12) have been retracted due to fabrication of the data, which has rendered the results of this meta-analysis invalid. ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,撤回出版物
doi:10.1007/s40261-018-0643-3
更新日期:2018-05-01 00:00:00
abstract::The role of postprandial hyperglycaemia in contributing to the risk of both micro- and macrovascular complications in patients with diabetes mellitus is being increasingly recognized. In type 2 diabetes, there is a progressive shift in the relative contributions of postprandial and fasting hyperglycaemia to the overal...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/00044011-200828040-00001
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:First-line bevacizumab-based therapy has been shown to improve outcomes in patients with advanced non-squamous non-small-cell lung cancer (NSCLC). The recent international phase IV SAiL study (a Study of Avastin [bevacizumab] in combination with platinum-containing chemotherapy in patients with...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-012-0001-9
更新日期:2012-11-01 00:00:00
abstract:INTRODUCTION:The management of advanced gastrointestinal stromal tumors (GISTs) has been modified considerably by the availability of costly tyrosine kinase inhibitors (TKIs); however, the best therapeutic sequence in terms of cost and effectiveness remains unknown. OBJECTIVE:The aim of this study was to compare four ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0463-2
更新日期:2017-01-01 00:00:00
abstract::Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population. The minor manifestation of the condition is the most common and is characterised by small, shallow, round or oval lesions that are surrounded by a raised erythematous h...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525090-00001
更新日期:2005-01-01 00:00:00
abstract::The original version of this article unfortunately contained a mistake. The corresponding author was incorrect. ...
journal_title:Clinical drug investigation
pub_type: 已发布勘误
doi:10.1007/s40261-019-00817-1
更新日期:2019-07-01 00:00:00
abstract:OBJECTIVE:The efficacy and tolerability of acarbose were examined in a postmarketing surveillance study of 27 803 patients with diabetes mellitus (26 044 were diagnosed as having type 2 diabetes) over a 12-week treatment period. PATIENTS AND M ethods: Overall efficacy data were reported for type 1 and type 2 diabetes, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525100-00004
更新日期:2005-01-01 00:00:00
abstract::Epilepsy is common in children and adolescents where its prevalence is 3.2-5.5/1000. About one-third of patients also have attention deficit hyperactivity/impulsivity disorder (ADHD). The possible relationship between epilepsy and ADHD is still unclear, and ADHD symptoms (such as inattention, hyperactivity, behavioral...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-017-0585-1
更新日期:2018-01-01 00:00:00
abstract:BACKGROUND:The use of budesonide/formoterol as both maintenance and reliever therapy in asthma is recommended in many countries; however, there are limited data available for the Asian patient population. OBJECTIVE:This study aimed to evaluate the short-term safety and tolerability of a fixed high-dose combination of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11595440-000000000-00000
更新日期:2012-01-01 00:00:00
abstract:OBJECTIVES:This paper aimed to provide an overview from published randomised clinical trials of the efficacy and tolerability of lamotrigine monotherapy compared with carbamazepine and phenytoin when initiated in adult patients with newly diagnosed epilepsy. DESIGN:The review included two double-blind, randomised tria...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199816020-00005
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Fentanyl buccal soluble film (FBSF) is a small, bilayered, water-soluble polymer film (BioErodible MucoAdhesive; BEMA™) that adheres to the buccal mucosa and rapidly delivers fentanyl into the systemic circulation. It is approved for the treatment of cancer breakthrough pain in adult opioid-to...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11594670-000000000-00000
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Little is known about the effects of the calcium channel antagonist manidipine when it is added as a third drug in non-controlled hypertensive patients with diabetes mellitus receiving dual antihypertensive therapy. The aim of this study was to evaluate the response in terms of blood pressure (...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11587400-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:To investigate the efficacy and tolerability of high-dose N-acetylcysteine (NAC) in the treatment of patients with exacerbations of chronic obstructive pulmonary disease (COPD). DESIGN AND PATIENTS:Randomised, double-blind, double-dummy, placebo-controlled study in 123 patients experiencing an acute exacerba...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525060-00005
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND:Combining two standard-of-care medications for Alzheimer's disease (AD) into a single once-daily dosage unit may improve treatment adherence, facilitate drug administration, and reduce caregiver burden. A new fixed-dose combination (FDC) capsule containing 28 mg memantine extended release (ER) and 10 mg done...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-015-0296-4
更新日期:2015-07-01 00:00:00
abstract::Oral teneligliptin [Teneglucon® (Argentina)], a dipeptidyl peptidase-4 inhibitor, is indicated for the treatment of adults with type 2 diabetes (T2DM). This article reviews the pharmacology, therapeutic efficacy and tolerability of teneligliptin in the treatment of adults with T2DM. In 12- or 16-week, placebo-controll...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-015-0348-9
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:In England, the uptake of direct oral anticoagulants (DOACs) for stroke prevention in atrial fibrillation has been slow and varied across different Clinical Commissioning Groups (CCGs). This study aimed to profile the prescribing of oral anticoagulants for stroke prevention in patients with atr...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-019-00763-y
更新日期:2019-04-01 00:00:00
abstract::Lung infections caused by invasive filamentous fungi are very rare conditions in AIDS, but must be considered in patients with profound immune suppression especially in the presence of additional risk factors, such as hematologic malignancies, corticosteroid therapy, neutropenia, and chemotherapy. The authors report a...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0017-1
更新日期:2013-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:As compared with individual tablets, saxagliptin/metformin extended-release (XR) fixed-dose combination (FDC) tablets offer potential for increased patient compliance with the convenience of once-daily dosing. Two bioequivalence studies assessed the fed-state bioequivalence of saxagliptin/metf...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11590290-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This real-world study assessed the prevalence, risk factors for, and incidence of seizures in patients with metastatic castration-resistant prostate cancer (mCRPC). METHODS:Patients with mCRPC were selected from MarketScan Commercial and Medicare Supplemental Databases between 1 January 2009 a...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0578-0
更新日期:2017-12-01 00:00:00