Once-daily luliconazole cream 1% for the treatment of interdigital tinea pedis.

Luliconazole is an imidazole antifungal agent with a unique chemical structure. In this article, we summarize the in vitro data, animal studies and clinical trial data relating to the use of topical luliconazole cream 1% in the treatment of tinea pedis. Preclinical studies have demonstrated potent activity against dermatophytes.

A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides.

Objective: To compare the safety and effectiveness of small particle hyaluronic acid plus lidocaine (SPHAL) versus no treatment for lip augmentation and perioral rhytides.

Methods And Materials: Adults scoring 1 (very thin) to 2 (thin) on the Medicis Lip Fullness Scale (MLFS) for upper and lower lips were randomized (3:1) to SPHAL or no treatment. Treatment success was an MLFS increase ≥1 point at Week 8.

Access of efinaconazole topical solution, 10%, to the infection site by spreading through the subungual space.

Objective: To evaluate the ability of efinaconazole vehicle to reach the site of toenail onychomycosis by spreading through the subungual space between the nail plate and nail bed. Lacquer-based vehicles are primarily limited to application on the nail plate and dependent on nail plate permeation.

Methods: 11 patients (mean age 48.

Efinaconazole 10% solution in the treatment of onychomycosis of the toenails.

Background: Efinaconazole 10% solution is a new triazole antifungal agent developed for the topical treatment of onychomycosis. This article reviews the pooled results of the two pivotal clinical trials of this drug that have been performed in the United States, Canada, and Japan.

Methods: The two studies of 1,655 patients were both double-blind, vehicle-controlled, parallel-group, randomized, multicenter studies designed to determine the efficacy and safety of efinaconazole 10% solution in the treatment of mild-to-moderate onychomycosis of the toenails caused by dermatophytes.

Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

Background: Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis.

Objective: This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis.

Methods: A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days.

The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials.

Background: Onychomycosis is a fungal infection of the nail apparatus that can be challenging to treat due to the modest efficacy of existing antifungal therapies and a high rate of relapse and recurrence.

Objectives: To investigate the efficacy and safety of efinaconazole 10% solution in pooled Phase III clinical trial participants with mild to moderate onychomycosis.

Methods: Phase III clinical trials data from NCT01008033 and NCT01007708 were pooled.

Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study.

Background: Onychomycosis is a common nail infection that is difficult to treat successfully. The prevalence increases with age and is associated with diabetes. Oral treatments are limited by drug interactions and potential hepatotoxicity; topical treatments, by modest efficacy.

Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies.

Background: Onychomycosis is a common nail infection, often resulting in nail plate damage and deformity. Topical lacquer treatments have negligible efficacy. Oral treatments, although more efficacious, are limited by drug interactions and potential hepatotoxicity.

Rivastigmine transdermal patch and capsule in Alzheimer's disease: influence of disease stage on response to therapy.

Objectives: The cholinesterase inhibitor rivastigmine is approved for the symptomatic treatment of mild to moderate Alzheimer's disease (AD). This exploratory, hypothesis-forming analysis assessed response to rivastigmine according to severity of dementia at baseline.

Methods: This was a retrospective analysis of a large randomized, placebo-controlled trial (ENA713D2320).

Efficacy of rivastigmine transdermal patch on activities of daily living: item responder analyses.

Objective: In Alzheimer's disease (AD), rivastigmine has demonstrated statistically significant efficacy versus placebo on cognition and activities of daily living (ADL). The aim of this retrospective analysis was to further evaluate the treatment effects of rivastigmine on individual ADL items.

Methods: This exploratory analysis focused on the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) outcome from a large, international, 24-week, controlled trial of rivastigmine once-daily transdermal patch and twice-daily capsules in AD (CENA713D2320, NCT00099242).

Impact of rivastigmine patch and capsules on activities of daily living in Alzheimer's disease.

Background: Rivastigmine patches provide similar efficacy to rivastigmine capsules with a lower incidence of gastrointestinal side effects in patients with probable Alzheimer's disease (AD).

Methods: Post hoc analysis of a 24-week, prospective, international, randomized, double-blind, placebo- and active-controlled trial. Patients (n = 892) with probable AD received rivastigmine transdermal patches (9.

Switching from oral donepezil to rivastigmine transdermal patch in Alzheimer's disease: 20-week extension phase results.

Objective: To evaluate the long-term safety, tolerability, and efficacy of 2 strategies for switching from donepezil to rivastigmine transdermal patches in patients with mild to moderate Alzheimer's disease.

Method: This was a prospective, 25-week, randomized, open-label, parallel-group study to evaluate an immediate or delayed switch (7-day withdrawal) from donepezil (5 to 10 mg/d) to rivastigmine transdermal patches (4.6 mg/24 h).

Reviews: Effects of transdermal rivastigmine on ADAS-cog items in mild-to-moderate Alzheimer's disease.

Alzheimer's disease (AD) patients treated with rivastigmine transdermal patch have shown statistically significant differences versus placebo on the AD Assessment scale-cognitive subscale (ADAS-cog). In this retrospective analysis of a double-blind, placebo- and active-controlled, 24-week clinical trial, the specific effects of rivastigmine patch on individual ADAS-cog items and cognitive domains (memory, language, and praxis) were explored. The mean baseline to week 24 changes were calculated for each ADAS-cog item and domain in this exploratory, hypothesis-generating analysis.

Efficacy of rivastigmine on executive function in patients with Parkinson's disease dementia.

Background And Objective: Rivastigmine is approved in the USA for the treatment of mild to moderate Alzheimer's disease and Parkinson's disease dementia (PDD). Executive function (EF) deficits are a core symptom of PDD. The current objective was to investigate the effects of rivastigmine capsules versus placebo on EF in PDD, focusing on secondary outcome measures from a large, international, randomized, double-blind, placebo-controlled, 24-week trial (EXPRESS, CENA713B2311).

The ACTION study: methodology of a trial to evaluate safety and efficacy of a higher dose rivastigmine transdermal patch in severe Alzheimer's disease.

Background: Two sizes of rivastigmine patch (5 cm(2) and 10 cm(2)) are currently approved in the US and Europe, while a 20 cm(2) rivastigmine patch has also been tested. A 15 cm(2) rivastigmine patch may provide an optimal balance between efficacy and safety. Earlier studies have demonstrated the efficacy of rivastigmine in severe Alzheimer's disease (AD), and supported the use of a higher dose patch in AD.

Rivastigmine in the treatment of dementia associated with Parkinson's disease: effects on activities of daily living.

Aims: To investigate the effects of rivastigmine capsule 3-12 mg/day over 24 weeks on activities of daily living (ADLs) in patients with dementia associated with Parkinson's disease (PDD).

Methods: Post hocanalysis of a prospective, multicenter, randomized, double-blind, placebo-controlled trial in patients with PDD (>or=50 years) randomized to rivastigmine 3-12 mg/day (capsules bid) or placebo over 24 weeks. This analysis was carried out with three subscales derived from a factor analysis of the 23 items in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale.

Effects of rivastigmine transdermal patch and capsule on aspects of clinical global impression of change in Alzheimer's disease: a retrospective analysis.

Background: The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale is widely used in Alzheimer trials. It assesses cognition, activities of daily living (ADLs), behavior and global functioning. To advance the understanding of relationships between the ADCS-CGIC and scores from other commonly used tools, this analysis investigated the ability of each domain to measure change.

Effects of oral rivastigmine on cognitive domains in mild-to-moderate Alzheimer's disease.

Rivastigmine has beneficial effects on cognitive functioning in Alzheimer's disease (AD). Effects of cholinesterase inhibitors, particularly rivastigmine, on AD Assessment Scale-cognitive subscale (ADAS-cog) domains and individual items have rarely been analyzed. Results from 4 randomized, double-blind, placebo-controlled, 26-week rivastigmine capsule trials in patients with mild-to-moderate AD were pooled and ADAS-cog domains and individual items were evaluated.

Evaluating rivastigmine in mild-to-moderate Parkinson's disease dementia using ADAS-cog items.

Rivastigmine has been shown to improve cognition in patients with Parkinson's disease dementia (PDD). To further explore the impact of anticholinesterase therapy on PDD, Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) items were assessed in a retrospective analysis of a 24-week, double-blind, placebo-controlled trial of rivastigmine. Mean changes from baseline at week 24 were calculated for ADAS-cog item scores and for 3 cognitive domain scores.

Rivastigmine transdermal patch skin tolerability: results of a 1-year clinical trial in patients with mild-to-moderate Alzheimer's disease.

Background And Objectives: Transdermal patches provide non-invasive, continuous drug delivery, and offer significant potential advantages over oral treatments. With all transdermal treatments a proportion of patients will experience some form of skin reaction. The rivastigmine patch has been approved for the treatment of mild-to-moderate Alzheimer's disease (AD) since July 2007 in the US.

A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimer's disease: a post hoc analysis.

Objective: To investigate the tolerability and efficacy of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer's disease receiving concomitant memantine.

Research Design And Methods: Post hoc analysis of a 25-week, randomized, prospective, open-label, parallel-group study. Patients receiving donepezil were switched to rivastigmine patches (4.

Safety and tolerability of rivastigmine capsule with memantine in patients with probable Alzheimer's disease: a 26-week, open-label, prospective trial (Study ENA713B US32).

Objective: Rivastigmine, a dual cholinesterase inhibitor (ChEI), is widely approved for the symptomatic treatment of both mild-to-moderate Alzheimer's disease (AD) and Parkinson's disease dementia. Orally administered ChEIs may be associated with gastrointestinal (GI) side effects and add-on therapy with memantine, an N-methyl-d-aspartate receptor antagonist, approved for moderate-to-severe AD, may ameliorate such side effects. This was a 26-week, prospective, multicenter, single-arm, open-label pilot study to assess the safety and tolerability of rivastigmine capsules plus memantine in patients with moderate AD.

Switching from donepezil tablets to rivastigmine transdermal patch in Alzheimer's disease.

Objective: Evaluate safety and tolerability of switching from donepezil to rivastigmine transdermal patch in patients with mild to moderate Alzheimer's disease.

Methods: Prospective, parallel-group, open-label study to evaluate immediate or delayed switch from 5-10 mg/day donepezil to 4.6 mg/24 h rivastigmine following a 4-week treatment period.

The GRID-HAMD: standardization of the Hamilton Depression Rating Scale.

This report describes the GRID-Hamilton Depression Rating Scale (GRID-HAMD), an improved version of the Hamilton Depression Rating Scale that was developed through a broad-based international consensus process. The GRID-HAMD separates the frequency of the symptom from its intensity for most items, refines several problematic anchors, and integrates both a structured interview guide and consensus-derived conventions for all items. Usability was established in a small three-site sample of convenience, evaluating 29 outpatients, with most evaluators finding the scale easy to use.

Memantine treatment in patients with mild to moderate Alzheimer's disease already receiving a cholinesterase inhibitor: a randomized, double-blind, placebo-controlled trial.

Objective: To evaluate the efficacy and safety of memantine in patients with mild to moderate Alzheimer's disease (AD) receiving cholinesterase inhibitor (ChEI) treatment.

Methods: Participants (N= 433) with probable AD, Mini-Mental State Exam (MMSE) scores between 10-22 (inclusive), and concurrent stable use of ChEIs (donepezil, rivastigmine, galantamine) were randomized to placebo or memantine (20 mg once daily) for 24 weeks. Primary outcomes were changes from baseline on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and on Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) score.